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1.  Antipsychotic polypharmacy in a regional health service: a population-based study 
BMC Psychiatry  2012;12:42.
To analyse the extent and profile of outpatient regular dispensation of antipsychotics, both in combination and monotherapy, in the Barcelona Health Region (Spain), focusing on the use of clozapine and long-acting injections (LAI).
Antipsychotic drugs dispensed for people older than 18 and processed by the Catalan Health Service during 2007 were retrospectively reviewed. First and second generation antipsychotic drugs (FGA and SGA) from the Anatomical Therapeutic Chemical classification (ATC) code N05A (except lithium) were included. A patient selection algorithm was designed to identify prescriptions regularly dispensed. Variables included were age, gender, antipsychotic type, route of administration and number of packages dispensed.
A total of 117,811 patients were given any antipsychotic, of whom 71,004 regularly received such drugs. Among the latter, 9,855 (13.9%) corresponded to an antipsychotic combination, 47,386 (66.7%) to monotherapy and 13,763 (19.4%) to unspecified combinations. Of the patients given antipsychotics in association, 58% were men. Olanzapine (37.1%) and oral risperidone (36.4%) were the most common dispensations. Analysis of the patients dispensed two antipsychotics (57.8%) revealed 198 different combinations, the most frequent being the association of FGA and SGA (62.0%). Clozapine was dispensed to 2.3% of patients. Of those who were receiving antipsychotics in combination, 6.6% were given clozapine, being clozapine plus amisulpride the most frequent association (22.8%). A total of 3.800 patients (5.4%) were given LAI antipsychotics, and 2.662 of these (70.1%) were in combination. Risperidone was the most widely used LAI.
The scant evidence available regarding the efficacy of combining different antipsychotics contrasts with the high number and variety of combinations prescribed to outpatients, as well as with the limited use of clozapine.
PMCID: PMC3511232  PMID: 22587453
Antipsychotics; Clozapine; Antipsychotic combination; Outpatient setting
2.  Exploration of experiences in therapeutic groups for patients with severe mental illness: development of the Ferrara group experiences scale (FE- GES) 
BMC Psychiatry  2013;13:242.
Group therapies are routinely provided for patients with severe mental illness. The factors important to the group experience of patients are still poorly understood and are rarely measured. To support further research and practice, we aimed to develop a questionnaire that captures how patients experience groups within a community mental health context.
An initial pool of 39 items was conceptually generated to assess different aspects of group experiences. Items were completed by 166 patients with severe mental illness attending group therapies in community mental health services in Italy. Patients with different psychiatric diagnoses who attended at least 5 group sessions were included. An exploratory factor analysis was used to identify different dimensions of group experiences and to reduce the number of items for each dimension.
The resulting questionnaire has five subscales: 1) sharing of emotions and experiences, 2) cognitive improvement, 3) group learning, 4) difficulties in open expression and 5) relationships. Each subscale has 4 items. The scale and sub-scales have good internal consistency.
The Ferrara Group Experiences Scale is conceptually derived and assesses dimensions of group experience that are theoretically and practically relevant. It is brief, easy to use and has good psychometric properties. After further validation, the scale may be used for research into patient experiences across different group therapy modalities and for evaluation in routine care.
PMCID: PMC3851601  PMID: 24083824
Group therapy; Patient experiences; Severe mental illness; Community mental health care
3.  QTc and psychopharmacs: are there any differences between monotherapy and polytherapy 
Some psychotropic drugs are connected with prolongation of QT interval, increased risk of cardiac arrhythmias and greater incidence of sudden death, especially when used in combination. Concomitant use of antipsychotics and antidepressants is not rare in our clinical practice. The study compares the length of QT interval in patients on monotherapy with an antipsychotic or an antidepressant and patients taking polytherapy (an antipsychotic agent combined with an antidepressant).
Sixty-one hospitalized women who met the ICD-10 criteria for schizophrenia, schizoaffective psychosis, delusional disorder and mood disorder were included in the study. The monotherapy group was consisted of thirty-two women treated with an antipsychotic or an antidepressant while the polytherapy group was composed of twenty-nine women treated with an antipsychotic agent plus an antidepressant. Two electrocardiograms (ECGs) were obtained for each patient: the first was carried out before the treatment and the second after two weeks of treatment.
Statistical analysis was carried out by SPSS program and included unpaired and paired t test and Fisher's exact test.
Mean baseline QTc values did not differ between the groups (439 ± 22 ms was the same value found in the both groups; unpaired t test, p > 0.5). Mean QTc intervals after two weeks of treatment were also similar (439 ± 24 ms in the monotherapy group and 440 ± 20 ms in the polytherapy group; unpaired t test, p > 0.5). Fisher's exact test did not reveal significant difference in the number of patients with borderline (451–470 ms) or prolonged (> 470 ms) QTc between groups, neither before treatment nor after two weeks of treatment. Twenty two women of the total of sixty one patients (36%) had QTc > 450 ms before applying therapy.
We did not find significant QT prolongation in our patients after two weeks of treatment with antipsychotics and/or antidepressants. The QTc interval length did not differ significantly in the monotherapy and the polytherapy group. More than one third of included women exceeded the threshold value of borderline QTc interval (450 ms) before starting treatment. This finding calls for caution when prescribing drugs to female psychiatric patients, especially if they have other health problems.
PMCID: PMC1871590  PMID: 17477877
4.  Retrospective Study of Japanese Patients with Schizophrenia Treated with Aripiprazole 
ISRN Nursing  2012;2012:454898.
Aim. The purpose of this retrospective study was to evaluate changes in clinical indicators which influence the quality of life (QOL) of patients with schizophrenia treated by antipsychotic therapy before and after switching to aripiprazole. Methods. A retrospective chart review of 27 patients diagnosed with schizophrenia and who were switched from one antipsychotic to aripiprazole was performed. Clinical indicators about the daily dosage of antipsychotics and antiparkinsonian drugs, psychiatric condition, and glucose/lipid metabolism, clinical evaluation by nursing observation were used to measure the responsiveness of subjects to aripiprazole. Results. Of the 27 subjects, 14 responded to the switch to aripiprazole with significant improvement of the Brief Psychiatric Rating Scale (BPRS) score (P = 0.04), significant decrease in dosage of antipsychotics in 71% of patients (P = 0.03), and tendency toward reduction in dosage of antiparkinsonian drugs (P = 0.07) and body mass index (BMI) (P = 0.06). However, 8 of 27 subjects had a significant increase in lipid levels after switching to aripiprazole (P = 0.01). Conclusion. QOL for subjects who responded to the switch to aripiprazole improved as indicated by lower doses of antipsychotic and antiparkinson medications, improvement in BPRS score, and a decrease in BMI. Results indicate little influence on patient's QOL.
PMCID: PMC3437285  PMID: 22970386
5.  Medication adherence levels and differential use of mental-health services in the treatment of schizophrenia 
BMC Research Notes  2009;2:6.
Adherence to antipsychotics for schizophrenia is associated with favorable clinical outcomes. This study compared annual mental-health service utilization by recent medication adherence levels for patients treated for schizophrenia, and assessed whether adherence levels change from pre- to post-psychiatric hospitalization.
We analyzed data from a large prospective, non-interventional study of patients treated for schizophrenia in the United States, conducted between 7/1997 and 9/2003. Detailed mental-health resource utilization was systematically abstracted from medical records and augmented with patients' self report. Medication possession ratio (MPR) with any antipsychotic in the 6 months prior to enrollment was used to categorize patients as: adherent (MPR ≥ 80%, N = 1758), partially adherent (MPR ≥ 60% < 80%, N = 36), or non-adherent (MPR < 60%, N = 216). Group comparisons employed propensity score-adjusted bootstrap re-sampling methods with 1000 iterations, adjusting for baseline patient demographic and clinical characteristics identified a priori.
Adherent patients had a lower rate of psychiatric hospitalization compared with partially adherent and non-adherent patients (p < 0.001) and were more likely than non-adherent to engage in group therapy, individual therapy, and medication management. Most patients (92.0%) who were adherent in the 6 months prior to hospital admission continued to be adherent 6 months following hospitalization. However, 75.0% of previously partially adherent became adherent, and 38.7% of previously non-adherent became adherent following hospitalization.
Adherence is associated with lower utilization of acute care services and greater engagement in outpatient mental-health treatment. Adherence is a potentially dynamic phenomenon, which may improve, at least temporarily, following patients' psychiatric hospitalizations.
PMCID: PMC2628922  PMID: 19138402
6.  Psychotropic Medication Burden and Factors Associated with Antipsychotic Use: An Analysis of a Population-Based Sample of Community-Dwelling Older Persons with Dementia 
To estimate the proportion of community dwelling older adults with dementia being prescribed a psychotropic and identify patient and caregiver factors associated with antipsychotics use.
Retrospective cohort study of The Aging, Demographics, and Memory Study (ADAMS) from 2002 to 2004 designed to assess dementia severity and service use among community-dwelling older adults. The frequency of psychotropic medication (antipsychotics, antidepressants, anticonvulsants and benzodiazepines) use was tabulated and weighted to the US population by dementia diagnosis. Logistic regression analysis identified factors associated with antipsychotic use.
The 307 participants of ADAMS had the following dementia diagnosis: Alzheimer’s disease (69.29%), vascular dementia (17.74%) and other dementia (12.39%). The proportion of participants prescribed a psychotropic medication broken down by therapeutic class was as 19.07% antipsychotics, 29.08% antidepressants, 9.84% benzodiazepines, and 8.85% anticonvulsants. Older adults with dementia were significantly more likely to receive an antipsychotic if they had moderate dementia (OR =7.4, p<0.05), or severe dementia (OR=5.80, p<0.05), compared to mild dementia or were diagnosed with Alzheimer (OR =6.7, p<0.05) dementia compared to vascular dementia.
Older adults with dementia who lived with their caregivers in were significantly less likely to be medicated with antipsychotics (OR= 0.19, p<0.05) compared to those who lived alone. Also, persons with dementia were significantly less likely to be prescribed an antipsychotic if the caregivers were clinically depressed (OR=0.03, p<0.05) compared to those who were not depressed.
We found psychotropic medication use is common among community-dwelling older adults with dementia. Caregivers appear to have a substantial impact on whether or not an antipsychotic is prescribed, which adds additional complexity to conversations discussing the risk-benefit ratio of this medication class.
PMCID: PMC3230879  PMID: 22092099
Antipsychotic Use; Dementia; Health Retirement Study (HRS); The Aging; Demographics; Memory Study (ADAMS)
7.  Correlation of adverse effects of cisplatin administration in patients affected by solid tumours: A retrospective evaluation 
Oncology Reports  2013;29(4):1285-1292.
Cisplatin is the most common antineoplastic drug used for the therapy of solid tumours. To date, researchers have focused on the dosage to be administered for each specific tumour, mainly considering the local adverse effects. The aim of this study was to correlate the severity of the adverse effects with: i) the dosage of cisplatin; ii) the specific site of the tumour; iii) the association with other drugs; and iv) the symptoms. We analysed data from 123 patients with 11 different tumour classes undergoing therapy from 2007 to 2008 at St. Anna Hospital (Ferrara, Italy), using the Spearman non-parametric correlation index. Even though significant correlations were found among the variables, the overall results showed that the main factor influencing the severity of the adverse effects was the dosage of cisplatin administered.
PMCID: PMC3621656  PMID: 23404427
adverse effect correlation; cisplatin toxicity; solid tumours; chemotherapy
8.  Metabolic risk factor profile associated with use of second generation antipsychotics: a cross sectional study in a community mental health centre 
BMC Psychiatry  2006;6:11.
Second generation antipsychotics (SGA) have demonstrated several advantages over first generation antipsychotics (FGA) in terms of positive, negative, cognitive, and affective symptoms and a lower propensity for extrapyramidal side effects. Despite these undeniable advantages, SGA have been associated with causing and exacerbating metabolic disorders, such as obesity, diabetes, and hyperlipidemia. This cross sectional study aimed to evaluate the metabolic risk factor profile associated with use of SGAs in comparison with non -treated control patients.
The study was carried out at a Community Mental Health Centre (CMHC) in Bologna. The study subjects were outpatients with serious mental disorders treated with SGA (clozapine, olanzapine, risperidone, quetiapine). A sample of adult men and women suffering from idiopathic hyperhydrosis, without psychiatric history or antipsychotic treatment, were randomly selected from outpatients of the Department of Neurology in Bologna as a reference group. We investigated differences among the treatment and reference groups for glycaemia, cholesterolaemia and triglyceridaemia levels.
The study sample was composed of 76 patients, 38 males and 38 females. The reference group was composed of 36 subjects, 19 females and 17 males. All patients treated with SGAs had higher mean glycaemia and triglyceridaemia and a significantly higher risk of receiving a diagnosis of hyperglycaemia and hypertriglyceridaemia than the reference group. We did not find any differences in mean glycaemia or mean triglyceridaemia levels among treatment groups. Patients with clozapine had a significantly higher mean BMI value and rate of obesity than patients treated with other SGAs.
The rate of obesity and metabolic disorders observed in this study were higher than the prevalence in the control group and similar to that previously reported in psychiatric samples; these findings imply per se that more attention should be paid to the metabolic condition of psychiatric patients. In line with the International Consensus Conferences we recommend that monitoring of weight, fasting plasma glucose, cholesterol and triglyceride levels be obtained in routine clinical practice with all antipsychotics.
PMCID: PMC1435746  PMID: 16542430
9.  Iron Deficiency in Pediatric Patients in Long-Term Risperidone Treatment 
Atypical antipsychotics, increasingly used in children and adolescents, modulate brain dopamine. Iron plays a critical role in dopaminergic signaling. Therefore, we explored whether body iron status is related to psychiatric symptom severity, treatment response, and tolerability following extended antipsychotic therapy.
Between November 2005 and August 2009, medically healthy 7–17-year-old risperidone-treated participants enrolled in a cross-sectional study examining the long-term safety of this antipsychotic. Anthropometric measurements were obtained. Psychiatric symptom severity and dietary intake were assessed. Serum ferritin, transferrin receptor, and prolactin concentrations were measured. Linear multivariable regression analysis tested the association among body iron, symptom severity, the dose of risperidone and psychostimulants, and serum prolactin concentration.
The sample consisted of 115 patients (87% males) with a mean (±SD) age of 11.6 (±2.8) years. The majority had externalizing disorders, and they had taken risperidone for 2.4 (±1.7) years. Body iron was low, with 45% having iron depletion and 14% having iron deficiency. Iron status was inversely associated with weight gain during risperidone treatment and with interleukin-6. Body iron was neither associated with psychiatric symptom severity nor with the daily dose of risperidone and psychostimulants. It was, however, inversely associated with prolactin concentration, which was nearly 50% higher in the iron-deficient group.
Iron depletion and deficiency are prevalent in children and adolescents chronically treated with risperidone. Iron deficiency accentuates the antipsychotic-induced elevation in prolactin. Future studies should confirm this finding and investigate the potential benefit of iron supplementation in antipsychotic-treated patients.
PMCID: PMC3609616  PMID: 23480322
10.  Fluvoxamine monotherapy for psychotic depression: the potential role of sigma-1 receptors 
Psychotic depression is a clinical subtype of major depressive disorder. A number of clinical studies have demonstrated the efficacy of the combination of an antidepressant (for example, a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI)) and an atypical antipsychotic or electroconvulsive therapy in treating psychotic depression. In some cases, the clinician or patient may prefer to avoid antipsychotic drugs altogether because of the risk of extrapyramidal side effects (EPS) in patients with psychotic depression treated with these drugs.
We report five cases where fluvoxamine monotherapy was effective in the patients with psychotic depression.
The scores on the Hamilton Depression (HAM-D) scale and the Brief Psychiatric Rating Scale (BPRS) in the five patients with psychotic depression were reduced after fluvoxamine monotherapy.
Doctors should consider fluvoxamine monotherapy as an alternative approach in treating psychotic depression because it avoids the risk of EPS from antipsychotic drugs.
PMCID: PMC2803775  PMID: 20025739
11.  Comparative Effectiveness of Second-Generation Antipsychotic Medications in Early-Onset Schizophrenia 
Schizophrenia Bulletin  2011;38(4):845-853.
Scant information exists to guide pharmacological treatment of early-onset schizophrenia. We examine variation across commonly prescribed second-generation antipsychotic medications in medication discontinuation and psychiatric hospital admission among children and adolescents clinically diagnosed with schizophrenia. A 45-state Medicaid claims file (2001–2005) was analyzed focusing on outpatients, aged 6–17 years, diagnosed with schizophrenia or a related disorder prior to starting a new episode of antipsychotic monotherapy with risperidone (n = 805), olanzapine (n = 382), quetiapine (n = 260), aripiprazole (n = 173), or ziprasidone (n = 125). Cox proportional hazard regressions estimated adjusted hazard ratios of 180-day antipsychotic medication discontinuation and 180-day psychiatric hospitalization for patients treated with each medication. During the first 180 days following antipsychotic initiation, most youth treated with quetiapine (70.7%), ziprasidone (73.3%), olanzapine (73.7%), risperidone (74.7%), and aripirazole (76.5%) discontinued their medication (χ2 = 1.69, df = 4, P = .79). Compared with risperidone, the adjusted hazards of antipsychotic discontinuation did not significantly differ for any of the 4-comparator medications. The percentages of youth receiving inpatient psychiatric treatment while receiving their initial antipsychotic medication ranged from 7.19% (aripiprazole) to 9.89% (quetiapine) (χ2 = 0.79, df = 4, P = .94). As compared with risperidone, the adjusted hazard ratio of psychiatric hospital admission was 0.96 (95% CI: 0.57–1.61) for olanzapine, 1.03 (95% CI: 0.59–1.81) for quetiapine, 0.85 (95% CI: 0.43–1.70) for aripiprazole, and 1.22 (95% CI: 0.60–2.51) for ziprasidone. The results suggest that rapid antipsychotic medication discontinuation and psychiatric hospital admission are common in the community treatment of early-onset schizophrenia. No significant differences were detected in risk of either adverse outcome across 5 commonly prescribed second-generation antipsychotic medications.
PMCID: PMC3406514  PMID: 21307041
schizophrenia; child psychiatry; antipsychotics; comparative effectiveness
12.  Costs of treating patients with schizophrenia who have illness-related crisis events 
BMC Psychiatry  2008;8:72.
Relatively little is known about the relationship between psychosocial crises and treatment costs for persons with schizophrenia. This naturalistic prospective study assessed the association of recent crises with mental health treatment costs among persons receiving treatment for schizophrenia.
Data were drawn from a large multi-site, non-interventional study of schizophrenia patients in the United States, conducted between 1997 and 2003. Participants were treated at mental health treatment systems, including the Department of Veterans Affairs (VA) hospitals, community mental health centers, community and state hospitals, and university health care service systems. Total costs over a 1-year period for mental health services and component costs (psychiatric hospitalizations, antipsychotic medications, other psychotropic medications, day treatment, emergency psychiatric services, psychosocial/rehabilitation group therapy, individual therapy, medication management, and case management) were calculated for 1557 patients with complete medical information. Direct mental health treatment costs for patients who had experienced 1 or more of 5 recent crisis events were compared to propensity-matched samples of persons who had not experienced a crisis event. The 5 non-mutually exclusive crisis event subgroups were: suicide attempt in the past 4 weeks (n = 18), psychiatric hospitalization in the past 6 months (n = 240), arrest in the past 6 months (n = 56), violent behaviors in the past 4 weeks (n = 62), and diagnosis of a co-occurring substance use disorder (n = 413).
Across all 5 categories of crisis events, patients who had a recent crisis had higher average annual mental health treatment costs than patients in propensity-score matched comparison samples. Average annual mental health treatment costs were significantly higher for persons who attempted suicide ($46,024), followed by persons with psychiatric hospitalization in the past 6 months ($37,329), persons with prior arrests ($31,081), and persons with violent behaviors ($18,778). Total cost was not significantly higher for those with co-occurring substance use disorder ($19,034).
Recent crises, particularly suicide attempts, psychiatric hospitalizations, and criminal arrests, are predictive of higher mental health treatment costs in schizophrenia patients.
PMCID: PMC2533651  PMID: 18727831
13.  Pneumonia following antipsychotic prescriptions in electronic health records: a patient safety concern? 
The British Journal of General Practice  2010;60(579):e385-e394.
In screening the Intercontinental Medical Statistics (IMS) Health Disease Analyzer database of GP records from the UK, an increased registration of pneumonia subsequent to the prescription of some antipsychotic medicines was identified.
To investigate the temporal pattern between antipsychotic prescriptions and pneumonia with respect to age, type of pneumonia and other chest infections, and antipsychotic class.
Design of study
Self-controlled cohort analysis.
Electronic health records from the UK IMS Health Disease Analyzer database.
Three groups of pneumonia-related International Classification of Diseases (ICD)-10 terms and prescriptions of atypical and conventional antipsychotic medicines were studied. Separate analyses were carried out for patients aged a65 years. The observed rate of pneumonia terms registered in different time periods in connection to antipsychotic prescriptions was contrasted to the overall rate of pneumonia terms relative to prescriptions of other drugs in the same dataset.
In patients aged ≥65 years, an increased registration of a group of terms defined as ‘acute chest infections’, after atypical antipsychotic prescriptions, was identified. The corresponding increase after conventional antipsychotic prescriptions was much smaler. Bronchopneumonia had a striking increase after both atypical and conventional antipsychotic prescriptions, and was commonly recorded with fatal outcome. Few registrations of hypostatic pneumonia were noted. Patients aged <65 years did not have a higher rate of acute chest infections after receiving antipsychotic prescriptions.
The consistent pattern of an increased rate of chest infections after atypical antipsychotic prescriptions in older people seen in this outpatient study, together with the higher risk shown in a previous study on hospitalised patients, suggests a causal relationship. This is of importance since bronchopneumonia seems highly linked to fatal outcome. In the absence of a mechanism, further investigation of the role of antipsychotics in older people is needed.
PMCID: PMC2944948  PMID: 20883613
aged; antipsychotic agents; computerised medical records systems; pneumonia
14.  Combined Venlafaxine and Olanzapine Prescription in Women with Psychotic Major Depression: A Case Series 
Case Reports in Medicine  2011;2011:856903.
Patients with psychotic major depression suffer prolonged duration and greater severity of illness, including an increased likelihood of recurrent episodes and resistance to conventional pharmacotherapies. They do not respond to placebo and respond poorly to antidepressant or antipsychotic monotherapy. On the other hand, as has been demonstrated, they do respond well to antidepressant and antipsychotic combination therapies. Different combinations of drugs were studied, but little is known up to now with regard to the combination of venlafaxine and olanzapine. The following paper presents three separate case studies of female patients suffering from psychotic unipolar major depression, all of whom were admitted to a psychiatric ward and successfully treated with a combination of venlafaxine and olanzapine.
PMCID: PMC3087461  PMID: 21547217
15.  Cardiometabolic Risk of Second-Generation Antipsychotics During First-Time Use in Children and Adolescents 
Cardiometabolic effects of second-generation antipsychotics (SGAs) are concerning, but have been insufficiently studied in antipsychotic-naïve and pediatric patients.
To study SGAs effects on body composition and metabolic parameters, unconfounded by prior antipsychotic exposure.
Three-month, non-randomized Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) cohort study, conducted 12.2001–09.2007.
Semi-urban, tertiary care, academic inpatient and outpatient services in Queens, New York, with a 4.5 million people catchment area.
Of 505 youth, aged 4–19 (mean age: 13.9±3.6) years with ≤1 week antipsychotic exposure, 338 (66.9%) were enrolled. Of these, 272 (80.5%) had ≥1 post-baseline assessment forming the final sample, and 205 (61.7%) completed the study. Patients had mood spectrum (n=130, 47.8%), schizophrenia spectrum (n=82, 30.1%) and disruptive/aggressive behavior spectrum disorders (n=60, 22.1%). Fifteen refusing/non-adherent patients served as a comparison group.
12-week treatment with aripiprazole, olanzapine, quetiapine or risperidone.
Main Outcome Measures
Body composition (weight, Body Mass Index percentile/z-score, fat mass, waist circumference), and fasting glucose and lipid parameters.
Weight increased by 19.0(95% Confidence Interval:16.4, 21.5)lbs=15.2(13.2, 17.2)% with olanzapine (N=45), 13.5(10.9, 16.0)lbs=10.4(8.5, 12.3)% with quetiapine (N=36), 11.9(10.7, 13.1)bs=10.4(9.4, 11.3)% with risperidone (N=135), and 9.9(8.2, 11.5)lbs=8.1(7.0, 9.5)% with aripiprazole (N=41). Comparison subjects (N=15) changed weight minimally: 0.4(−2.3, 3.2)lbs=0.7(−1.3, 2.6)%. Weight gain ≥7% occurred in 84.4% (n=38) of patients on olanzapine, 64.4% (n=87) on risperidone, 58.4% (n=24) on aripiprazole, 55.6% (n=20) on quetiapine, and 0% of comparison subjects. With olanzapine, cholesterol (p<.001), triglycerides (p=0.002), non-HDL-cholesterol (p<.001), triglyceride/HDL ratio (p=0.002), glucose (p=0.02), insulin (p=0.02), and HOMA-IR (p=0.03) increased significantly. With quetiapine, cholesterol (p<0.05), triglycerides (p=0.01), non-HDL-cholesterol (p=0.03), and triglyceride/HDL ratio (p=0.004) increased significantly. With risperidone, triglycerides (p=0.04) increased significantly. Metabolic baseline-to-endpoint changes were non-significant with aripiprazole and comparison subjects. Dyslipidemia developed in 28.9% (n=13), 19.4% (n=26), 8.8% (n=3), and 7.3% (n=3) of youth on olanzapine, risperidone, quetiapine and aripiprazole, and 6.7% (n=1) of comparison subjects (p=0.03), while acquired insulin resistance (HOMA-IR>4.39: 2.9%–17.8%) and metabolic syndrome (0%–6.5%) were relatively rare in this short-term study.
First time SGA use was associated with significant weight gain with each medication. Metabolic changes varied among the 4 antipsychotics.
PMCID: PMC3055794  PMID: 19861668
Second-generation Antipsychotics; Antipsychotic-naïve; Weight Gain; Insulin Resistance; Dyslipidemia; Metabolic Syndrome; Cardiometabolic Risk; Children; Adolescents
16.  Patient perspectives in the development and use of long-acting antipsychotics in schizophrenia: focus on olanzapine long-acting injection 
Schizophrenia is a chronic mental disorder generally treated with antipsychotic medication. However, non-adherence and partial adherence to antipsychotic medication treatment is common and long-acting injectable “depot” preparations of antipsychotic medications have been used as an alternative to oral medication therapy for patients for whom adherence is a clinically significant problem, as well as for the sake of convenience and in response to patient preference. Olanzapine long-acting injection (OLAI) is a new treatment option and has been approved by several regulatory agencies for the treatment of schizophrenia. OLAI is a crystalline salt formulation of olanzapine and pamoic acid. Efficacy was established in 2 double-blind randomized clinical trials of OLAI for the treatment of acute schizophrenia and for the maintenance of response. The therapeutic OLAI dosages are 150 mg q2 weeks, 210 mg q2 weeks, 300 mg q2 weeks or q4 weeks, and 405 mg q4 weeks, administered by deep intramuscular gluteal injection with a 19-gauge needle. Injection volume ranges from 1 to 2.7 mL. OLAI has essentially the same general tolerability as that of oral olanzapine; however with the depot there is the additional risk of a post-injection delirium sedation syndrome occurring at a rate of 0.07% of injections, requiring a risk management plan that includes observing the patient for 3 hours post injection.
PMCID: PMC2792872  PMID: 20016798
adherence; antipsychotic; depot; long-acting; olanzapine pamoate; schizophrenia
17.  Retrospective Analysis of Diabetes Care in California Medicaid Patients with Mental Illness 
Serious mental illness often is associated with an increased risk of diabetes and sub-optimal diabetes care.
To examine diabetes prevalence and care among Medicaid patients from one county mental health system.
Retrospective cohort study combining county records and 12 months of state Medicaid claims.
Patients ages 18 to 59 receiving mental health services between November 1 and 14, 2004.
Dependent variables were glycolated hemoglobin A1C (HbA1c) testing, lipid testing, and eye examinations. Psychiatric status was assessed by second generation antipsychotic prescription (SGA) and low Global Assessment of Functioning (GAF) score.
Among psychiatric patients, 482 (11.8%) had diabetes. Among those with diabetes, 47.3% received annual HbA1c testing, 56.0% lipid testing, and 31.7% eye examinations. Low GAF scores were associated with lower likelihood of lipid testing (OR 0.43). SGA prescription reduced the likelihood of HbA1c testing (OR 0.58) but increased the likelihood of eye examinations (OR 2.02). Primary care visits were positively associated with HbA1c and lipid testing (ORs 5.01 and 2.21, respectively). Patients seen by a fee-for-service psychiatrist were more likely to have lipid testing (OR 2.35) and eye examinations (OR 2.03).
Among Medicaid psychiatric patients, worse diabetes care was associated with SGA prescription, more serious psychiatric symptoms, and receiving psychiatric care only in public mental health clinics. Diabetes care improved when patients were seen by fee-for-service psychiatrists or primary care physicians. Further study is needed to identify methods for improving diabetes care of public mental health patients.
PMCID: PMC2695534  PMID: 19415391
diabetes; Medicaid; mental health; health services research; quality assessment
18.  Evaluation of Defined Daily Dose, percentage of British National Formulary maximum and chlorpromazine equivalents in antipsychotic drug utilization 
The present study was carried out to investigate and compare the three methods for calculating total antipsychotic dose among outpatients with schizophrenia attending primary psychiatric health care centers. The three methods were: Defined Daily Doses (DDDs), chlorpromazine equivalents (CPZeq) and percentages of the British National Formulary (BNF) maximum.
Antipsychotic drug dosing data for 250 patients with schizophrenia were investigated by calculating Spearman’s rank correlation coefficients. Factors associated with antipsychotic dose, expressed as DDDs, CPZeq and percentages of the BNF maximum recommended daily dose, were investigated by means of linear regression analysis.
Spearman’s correlation showed that there is a significant relationship between all pairs of the three dosing methods. In all three methods, coherence was strongest when dealing with first generation antipsychotics (FGA). Linear regression analyses showed a high degree of coherence between antipsychotic doses expressed as DDDs, CPZeq and percentages of the BNF maximum recommended daily dose.
All three tested methods are reliable and coherent for calculating antipsychotic dosing.
PMCID: PMC3950502  PMID: 24648824
%BNFmax, percentage of British National Formulary maximum; CPZeq, chlorpromazine equivalents; DDD, Defined Daily Dose (DDD); FGA, first generation antipsychotics; SGA, second generation antipsychotics; Antipsychotics; Chlorpromazine equivalents; Defined Daily Doses; Schizophrenia
19.  Lithium dosage and leukocyte counts in psychiatric patients. 
OBJECTIVE: To evaluate differences in leukocyte counts among patients treated with either lithium alone, antipsychotic medications alone, or a combination of both. DESIGN: Retrospective study. SETTING: Long-stay psychiatric hospital. PATIENTS: Patients admitted between 1990 and 1993, and treated with lithium for at least 1 week and/or with antipsychotic medication for at least 2 weeks. Excluded from the study were those patients for whom complete blood counts at baseline and during therapy were not available, and those patients whose blood picture could primarily be accounted for by extraneous factors. Included in the study were 38 patients treated with lithium alone, 207 patients receiving antipsychotic medications alone, and 71 patients receiving both. OUTCOME MEASURES: Leukocyte, lymphocyte and granulocyte counts. RESULTS: Patients treated with lithium alone had significantly higher mean leukocyte and granulocyte counts than those treated with antipsychotic medication alone (analysis of variance, p < 0.05). None of the patients receiving lithium alone showed leukopenia. The dosage of lithium was significantly correlated with leukocyte count (r = 0.25, 95% confidence interval [CI] 0.14 to 0.35, p < 0.001,) and granulocyte count (r = 0.27, 95% CI 0.16 to 0.38, p < 0.001), but not with lymphocyte count (r = 0.06, p = 0.286, 95% CI -0.05 to 0.17). CONCLUSIONS: Lithium therapy is associated with higher leukocyte and granulocyte levels in psychiatric patients. This leukocytotic effect of lithium may be dose dependent.
PMCID: PMC1189011  PMID: 10354655
20.  Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalization 
BMC Psychiatry  2013;13:246.
This study aimed to assess antipsychotic adherence patterns and all-cause and schizophrenia-related health care utilization and costs sequentially during critical clinical periods (i.e., before and after schizophrenia-related hospitalization) among Medicaid-enrolled patients experiencing a schizophrenia-related hospitalization.
All patients aged ≥ 18 years with a schizophrenia-related inpatient admission were identified from the MarketScan Medicaid database (2004–2008). Adherence (proportion of days covered [PDC]) to antipsychotics and schizophrenia-related and all-cause health care utilization and costs were assessed during preadmission (182- to 121-day, 120- to 61-day, and 60- to 0-day periods; overall, 6 months) and postdischarge periods (0- to 60-day, 61- to 120-day, 121- to 180-day, 181- to 240-day, 241- to 300-day, and 301- to 365-day periods; overall, 12 months). Health care utilization and costs (2010 US dollars) were compared between each adjacent 60-day follow-up period after discharge using univariate and multivariable regression analyses. No adjustment was made for multiplicity.
Of the 2,541 patients with schizophrenia (mean age: 41.2 years; 57% male; 59% black) who were identified, approximately 89% were “discharged to home self-care.” Compared with the 60- to 0-day period before the index inpatient admission, greater mean adherence as measured by PDC was observed during the 0- to 60-day period immediately following discharge (0.46 vs. 0.78, respectively). The mean PDC during the overall 6-month preadmission period was lower than during the 6-month postdischarge period (0.53 vs. 0.69; P < 0.001). Compared with the 0- to 60-day postdischarge period, schizophrenia-related health care costs were significantly lower during the 61- to 120-day postdischarge period (mean: $2,708 vs. $2,102; P < 0.001); the primary cost drivers were rehospitalization (mean: $978 vs. $660; P < 0.001) and pharmacy (mean: $959 vs. $743; P < 0.001). Following the initial 60-day period, both all-cause and schizophrenia-related costs declined and remained stable for the remaining postdischarge periods (days 121–365).
Although long-term (e.g., 365-day) adherence measures are important, estimating adherence over shorter intervals may clarify the course of vulnerability to risk and enable clinicians to better design adherence/risk-related interventions. The greatest risk of rehospitalization and thus greater resource utilization were observed during the initial 60-day postdischarge period. Physicians should consider tailoring management and treatment strategies to help mitigate the economic and humanistic burden for patients with schizophrenia during this period.
PMCID: PMC3853885  PMID: 24094241
Schizophrenia; Medicaid; Hospitalization; Health care utilization; Adherence
21.  Elderly Patients with Dementia-Related Symptoms of Severe Agitation and Aggression: Consensus Statement on Treatment Options, Clinical Trials Methodology, and Policy 
Atypical antipsychotic drugs have been used off-label in clinical practice for treatment of serious dementia-associated agitation and aggression. Following reports of cerebrovascular adverse events associated with the use of atypical antipsychotic in elderly patients with dementia, the FDA issued black box warnings for several atypical antipsychotics, titled “Cerebrovascular Adverse Events, including Stroke, in Elderly Patients with Dementia.” Subsequently, the FDA initiated a meta-analysis of safety data from 17 registration trials across six antipsychotic drugs (five atypical antipsychotics and haloperidol). In 2005, the Agency issued a black box warning regarding increased risk of mortality associated with the use of atypical antipsychotic drugs in this patient population. Geriatric mental health experts participating in a 2006 consensus conference reviewed evidence on the safety and efficacy of antipsychotics, as well as nonpharmacologic approaches, in treating dementia-related symptoms of agitation and aggression. They concluded that, while problems in clinical trials design may have been one of the contributors to the failure to find a signal of drug efficacy, the findings related to drug safety should be taken seriously by clinicians in assessing the potential risks and benefits of treatment in a frail population, and in advising families about treatment. Information provided to patients and family members should be documented in the patient’s chart. Drugs should be used only when non-pharmacologic approaches have failed to adequately control behavioral disruption. Participants also agreed that that there is a need for an FDA-approved medication for the treatment of severe, persistent or recurrent dementia-related symptoms of agitation and aggression (even in the absence of psychosis), that are unresponsive to nonpharmacologic intervention. The authors have outlined methodological enhancements to better evaluate treatment approaches in future registration trials, and they provided an algorithm for improving the treatment of these patients in nursing home and non-nursing home settings.
PMCID: PMC2674239  PMID: 18494535
agitation and aggression; psychosis of Alzheimer disease; atypical antipsychotics; conventional antipsychotics; mortality
22.  Effect of regulatory warnings on antipsychotic prescription rates among elderly patients with dementia: a population-based time-series analysis 
Three warnings of serious adverse events associated with the use of atypical antipsychotic drugs among elderly patients with dementia were sent to health care professionals in Canada. We assessed the impact of these warnings on prescription rates of antipsychotic drugs in this patient population.
We used prescription drug claims data from Ontario to calculate prescription rates of atypical and conventional antipsychotic drugs among elderly patients with dementia from May 1, 2000, to Feb. 28, 2007. We performed a time-series analysis to estimate the effect of each warning on rates of antipsychotic drug use.
Before the first warning, growth in the use of atypical antipsychotics was responsible for an increasing rate of overall antipsychotic use. Each warning was associated with a small relative decrease in the predicted growth in the use of atypical antipsychotic drugs: a 5.0% decrease after the first warning, 4.9% after the second and 3.2% after the third (each p < 0.05). The overall prescription rate of antipsychotic drugs among patients with dementia increased by 20%, from 1512 per 100 000 elderly patients in September 2002, the month before the first warning, to 1813 per 100 000 in February 2007, 20 months after the last warning.
Although the warnings slowed the growth in the use of atypical antipsychotic drugs among patients with dementia, they did not reduce the overall prescription rate of these potentially dangerous drugs. More effective interventions are necessary to improve postmarket drug safety in vulnerable populations.
PMCID: PMC2518182  PMID: 18725616
23.  The relationship between antipsychotic medication adherence and patient outcomes among individuals diagnosed with bipolar disorder: a retrospective study 
Reducing hospitalizations and emergency room visits is important to improve patient outcomes. This observational study examined the association between adherence to antipsychotics and risk of hospitalizations and emergency room (ER) visits among patients with bipolar disorder.
Claims data from commercial healthcare plans (Pharmetrics; January 2000 to December 2006) for patients with bipolar disorder receiving an antipsychotic prescription were examined. Adherence was analyzed over a 12-month follow-up period after the receipt of first prescription of an antipsychotic. Adherence to antipsychotics was measured by the medication possession ratio (MPR). The MPR was calculated as the number of days that an antipsychotic medication was filled as compared with the total number of days during the follow-up period. Logistic stepwise regressions examined the association between achievement of various adherence goals and patient outcomes (hospitalization or ER visit for mental health or any reason).
In total, 7,769 patients with bipolar disorder were included. The mean MPR was 0.417, with 61.7% of individuals having an MPR < 0.50, and 78.7% an MPR < 0.75. As adherence improved, the risk of hospitalization or ER visit declined. A significant reduction in the risk of hospitalization (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.75 to 0.98) or an ER visit (OR 0.84, 95% CI 0.74 to 0.96) for any cause was associated with an MPR ≥ 0.75. An MPR ≥ 0.80 was associated with a significant reduction in the risk of a mental health-related hospitalization (OR 0.82, 95% CI 0.70 to 0.95), while an MPR ≥ 0.90 was associated with a significant reduction in risk of a mental health-related ER visit (OR 0.71, 95% CI 0.54 to 0.91).
Patients with lower antipsychotic adherence were at greater risk of hospitalizations and ER visits. Thus, any efforts to increase adherence, even in small increments, can be helpful in decreasing these risks.
PMCID: PMC2649921  PMID: 19226463
24.  Antipsychotic monotherapy and polypharmacy in the naturalistic treatment of schizophrenia with atypical antipsychotics 
BMC Psychiatry  2005;5:26.
Antipsychotic monotherapy is recognized as the treatment of choice for patients with schizophrenia. Simultaneous treatment with multiple antipsychotics (polypharmacy) is suggested by some expert consensus guidelines as the last resort after exhausting monotherapy alternatives. This study assessed the annual rate and duration of antipsychotic monotherapy and its inverse, antipsychotic polypharmacy, among schizophrenia patients initiated on commonly used atypical antipsychotic medications.
Data were drawn from a large prospective naturalistic study of patients treated for schizophrenia-spectrum disorders, conducted 7/1997–9/2003. Analyses focused on patients (N = 796) who were initiated during the study on olanzapine (N = 405), quetiapine (N = 115), or risperidone (N = 276). The percentage of patients with monotherapy on the index antipsychotic over the 1-year post initiation, and the cumulative number of days on monotherapy were calculated for all patients and for each of the 3 atypical antipsychotic treatment groups. Analyses employed repeated measures generalized linear models and non-parametric bootstrap re-sampling, controlling for patient characteristics.
During the 1-year period, only a third (35.7%) of the patients were treated predominately with monotherapy (>300 days). Most patients (57.7%) had at least one prolonged period of antipsychotic polypharmacy (>60 consecutive days). Patients averaged 195.5 days on monotherapy, 155.7 days on polypharmacy, and 13.9 days without antipsychotic therapy. Olanzapine-initiated patients were significantly more likely to be on monotherapy with the initiating antipsychotic during the 1-year post initiation compared to risperidone (p = .043) or quetiapine (p = .002). The number of monotherapy days was significantly greater for olanzapine than quetiapine (p < .001), but not for olanzapine versus risperidone, or for risperidone versus quetiapine-initiated patients.
Despite guidelines recommending the use of polypharmacy only as a last resort, the use of antipsychotic polypharmacy for prolonged periods is very common during the treatment of schizophrenia patients in usual care settings. In addition, in this non-randomized naturalistic observational study, the most commonly used atypical antipsychotics significantly differed on the rate and duration of antipsychotic monotherapy. Reasons for and the impact of the predominant use of polypharmacy will require further study.
PMCID: PMC1156914  PMID: 15921508
25.  Drug Use Patterns in Severely Mentally Ill Medicare Beneficiaries: Impact of Discontinuities in Drug Coverage 
Health Services Research  2008;43(2):496-514.
To describe the extent of drug coverage among severely mentally ill Medicare beneficiaries and to determine whether and to what extent discontinuities in prescription drug coverage influence the use of medications used to treat serious mental health conditions.
Data Source
1997–2001 Medicare Current Beneficiary Surveys.
Study Design
We use a zero-inflated negative binomial model to estimate: (1) the probability of not receiving any mental health drug and (2) the number of medications received, adjusting for age, race, income, census region, health status, and comorbidity. Severe mental illness is defined using inpatient and outpatient claims with ICD-9 codes of schizophrenia, other psychotic disorders, bipolar disorders, and major depression. Mental health medications include antidepressants, antipsychotics, mood stabilizers, anxiolytic/sedative-hypnotics, and stimulants. Prescription drug coverage is assessed as full coverage (0 percent discontinuities), no coverage (100 percent discontinuities), or as discontinuous coverage, measured as 1–25, 26–50, and 51–99 percent of time without coverage.
Data Collection/Extraction Methods
We constructed three 3-year longitudinal cohorts of severely mentally ill Medicare beneficiaries residing in the community (n = 901).
Principal Findings
Severely mentally ill Medicare beneficiaries with drug coverage discontinuities are more likely than their continuously insured peers not to receive medications used to treat mental health disorders, with the most significant impact seen in the probability of receiving any psychiatric medications. Analysis of two therapeutic classes—antidepressants and antipsychotics—revealed varying impacts of drug gaps on both probability of any drug use, as well as number of medications received among users.
Severely mentally ill Medicare beneficiaries may be particularly vulnerable to the Medicare Part D drug benefit design and, as such, warrant close evaluation and monitoring to insure adequate access to and utilization of medications used to manage mental illness.
PMCID: PMC2442367  PMID: 18370965
Drug coverage; mental health; prescription drugs; Medicare; access

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