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1.  Cognitive Therapy Alone and in Combination with Antidepressants for Anxious Depression: A STAR*D Report 
Journal of affective disorders  2012;142(1-3):213-218.
Background
Anxious depression, defined as MDD with high levels of anxiety, has been associated with lower rates of antidepressant response and remission as well as greater chronicity, suicidality and antidepressant side-effect burden. The primary aim of this study was to assess the effectiveness of cognitive therapy (CT) alone or in combination with medications for anxious versus non-anxious depression.
Methods
We assessed the STAR*D study participants who were partial or non-responders to citalopram. Subjects were then either switched (n = 696) to a new antidepressant or to CT alone, or they were kept on citalopram and augmented (n = 577) with another antidepressant or CT. We compared response and remission rates of those who met criteria for anxious depression to those who did not across treatment conditions.
Results
Those with anxious depression had significantly lower remission rates based on the QIDS, whether assigned to switch or augmentation, compared to those with non-anxious depression. Those with anxious depression, compared to those without, had significantly lower response rates based on the QIDS only in the switch group. There was no significant interaction between anxious depression and treatment assignment.
Limitations
Limitations include the use of citalopram as the only Level 1 pharmacotherapy and medication augmentation option, depression-focused CT rather than anxiety-focused CT, and focus on acute treatment outcomes.
Conclusions
Individuals with anxious depression appear to experience higher risk of poorer outcome following pharmacotherapy and/or CT after an initial course of SSRI, and continued efforts to target this challenging form of depression are needed.
doi:10.1016/j.jad.2012.04.029
PMCID: PMC3483355  PMID: 22877961
anxious depression; MDD; CT; psychosocial interventions; STAR*D
2.  The Impact of HAART on the Respiratory Complications of HIV Infection: Longitudinal Trends in the MACS and WIHS Cohorts 
PLoS ONE  2013;8(3):e58812.
Objective
To review the incidence of respiratory conditions and their effect on mortality in HIV-infected and uninfected individuals prior to and during the era of highly active antiretroviral therapy (HAART).
Design
Two large observational cohorts of HIV-infected and HIV-uninfected men (Multicenter AIDS Cohort Study [MACS]) and women (Women’s Interagency HIV Study [WIHS]), followed since 1984 and 1994, respectively.
Methods
Adjusted odds or hazards ratios for incident respiratory infections or non-infectious respiratory diagnoses, respectively, in HIV-infected compared to HIV-uninfected individuals in both the pre-HAART (MACS only) and HAART eras; and adjusted Cox proportional hazard ratios for mortality in HIV-infected persons with lung disease during the HAART era.
Results
Compared to HIV-uninfected participants, HIV-infected individuals had more incident respiratory infections both pre-HAART (MACS, odds ratio [adjusted-OR], 2.4; 95% confidence interval [CI], 2.2–2.7; p<0.001) and after HAART availability (MACS, adjusted-OR, 1.5; 95%CI 1.3–1.7; p<0.001; WIHS adjusted-OR, 2.2; 95%CI 1.8–2.7; p<0.001). Chronic obstructive pulmonary disease was more common in MACS HIV-infected vs. HIV-uninfected participants pre-HAART (hazard ratio [adjusted-HR] 2.9; 95%CI, 1.02–8.4; p = 0.046). After HAART availability, non-infectious lung diseases were not significantly more common in HIV-infected participants in either MACS or WIHS participants. HIV-infected participants in the HAART era with respiratory infections had an increased risk of death compared to those without infections (MACS adjusted-HR, 1.5; 95%CI, 1.3–1.7; p<0.001; WIHS adjusted-HR, 1.9; 95%CI, 1.5–2.4; p<0.001).
Conclusion
HIV infection remained a significant risk for infectious respiratory diseases after the introduction of HAART, and infectious respiratory diseases were associated with an increased risk of mortality.
doi:10.1371/journal.pone.0058812
PMCID: PMC3595204  PMID: 23554932
3.  The Effect of Concurrent Substance Use Disorder on the Effectiveness of Single and Combination Antidepressant Medications for the Treatment of Major Depression: An Exploratory Analysis of a Single-Blind Randomized Trial 
Depression and Anxiety  2012;29(2):111-122.
Background
The co-occurrence of substance use disorder (SUD) and major depressive disorder (MDD) is common and is often thought to impair response to antidepressant therapy. These patients are often excluded from clinical trials, resulting in a significant knowledge gap regarding optimal pharmacotherapy for the treatment of MDD with concurrent SUD.
Methods
In the Combining Medications to Enhance Depression Outcomes study, 665 adult outpatients with chronic and/or recurrent MDD were prospectively treated with either escitalopram monotherapy (escitalopram and placebo) or an antidepressant combination (venalfaxine-XR and mirtazapine or escitalopram and bupropion-SR). Participants with MDD and concurrent SUD (13.1%) were compared to those without SUD (86.9%) on sociodemographic and clinical characteristics at baseline and treatment response at 12-week and 28-week endpoints.
Results
The participants with MDD and SUD were more likely to be male and have current suicidal thoughts/plans, and had a greater lifetime severity and number of suicide attempts, and a higher number of concurrent Axis I disorders, particularly concurrent anxiety disorders. There were no significant differences between the MDD with or without SUD groups in terms of dose, time in treatment, response or remission at week 12 and 28. Furthermore, no significant differences in response or remission rates were noted between groups on the basis of the presence or absence of SUD and treatment assignment.
Conclusions
Although significant baseline sociodemographic and clinical differences exist, patients with MDD and concurrent SUD are as likely to respond and remit to a single or combination antidepressant treatment as those presenting without SUD.
doi:10.1002/da.20918
PMCID: PMC3325509  PMID: 22495941
major depressive disorder; substance use disorder; dual diagnosis; combination antidepressants; treatment outcome
4.  Medical Conditions Associated with Out-of-Hospital Endotracheal Intubation 
OBJECTIVE
While prior studies describe the clinical presentation of patients requiring paramedic out-of-hospital endotracheal intubation (ETI), limited data characterize the underlying medical conditions or comorbidities. We sought to characterize the medical conditions and comorbidities of patients receiving successful paramedic out-of-hospital ETI.
METHODS
We used Pennsylvania statewide EMS clinical data, including all successful ETIs performed during 2003–2005. Using multiple imputation triple-match algorithms, we probabilistically linked EMS ETI to statewide death and hospital admission data. Each hospitalization record contained one primary and up to eight secondary diagnoses, classified according to the International Classification of Diseases, Clinical Modification, ninth edition (ICD-9-CM). We determined the proportion of patients in each major ICD-9-CM diagnostic group and subgroup. We calculated the Charlson Comorbidity Index for each patient. Using binomial proportions with confidence intervals, we analyzed the data and combined imputed results using Rubin's method.
RESULTS
Across the imputed sets, we linked 25,733 (77.7% linkage) successful ETI to death or hospital records; 56.3% died before and 43.7% survived to hospital admission. Of the 14,479 deaths before hospital admission, most (92.7%, 95% CI: 92.5–93.3%) presented to EMS in cardiac arrest. Of the 11,255 hospitalized patents, the leading primary diagnoses were circulatory diseases (32.0%, 30.2–33.7%), respiratory diseases (22.8%, 21.9–23.7%), and injury or poisoning (25.2%; 22.7–27.8%). Prominent primary diagnosis subgroups included: asphyxia and respiratory failure (15.2%), traumatic brain injury and skull fractures (11.3%), acute myocardial infarction and ischemic heart disease (10.9%), poisoning, drug and alcohol disorders (6.7%), dysrhythmias (6.7%), hemorrhagic and non-hemorrhagic stroke (5.9%), acute heart failure and cardiomyopathies (5.6%), pneumonia and aspiration (4.9%), and sepsis, septicemia and septic shock (3.2%). Most of the admitted ETI patients had a secondary circulatory (70.8%), respiratory (61.4%), or endocrine, nutritional or metabolic secondary diagnosis (51.4%). The mean Charlson Index score was 1.6 (95% CI: 1.5–1.7).
CONCLUSIONS
The majority of successful paramedic ETI occur on patients with cardiac arrest, circulatory and respiratory conditions. Injury, poisoning and other conditions compromise smaller but important portions. ETI patients have multiple comorbidities. These findings may guide the systemic planning of paramedic airway management care and education.
doi:10.3109/10903127.2011.569850
PMCID: PMC3103090  PMID: 21612386
Emergency Medical Services; Paramedics; Intubation Intratracheal; Comorbidities
5.  Out-of-Hospital Endotracheal Intubation Experience and Patient Outcomes 
Annals of emergency medicine  2010;55(6):527-537.e6.
Study objective
Previous studies suggest improved patient outcomes for providers who perform high volumes of complex medical procedures. Out-of-hospital tracheal intubation is a difficult procedure. We seek to determine the association between rescuer procedural experience and patient survival after out-of-hospital tracheal intubation.
Methods
We analyzed probabilistically linked Pennsylvania statewide emergency medicine services, hospital discharge, and death data of patients receiving out-of-hospital tracheal intubation. We defined tracheal intubation experience as cumulative tracheal intubation during 2000 to 2005; low=1 to 10 tracheal intubations, medium=11 to 25 tracheal intubations, high=26 to 50 tracheal intubations, and very high=greater than 50 tracheal intubations. We identified survival on hospital discharge of patients intubated during 2003 to 2005. Using generalized estimating equations, we evaluated the association between patient survival and out-of-hospital rescuer cumulative tracheal intubation experience, adjusted for clinical covariates.
Results
During 2003 to 2005, 4,846 rescuers performed tracheal intubation. These individuals performed tracheal intubation on 33,117 patients during 2003 to 2005 and 62,586 patients during 2000 to 2005. Among 21,753 cardiac arrests, adjusted odds of survival was higher for patients intubated by rescuers with very high tracheal intubation experience; adjusted odds ratio (OR) versus low tracheal intubation experience: very high 1.48 (95% confidence interval [CI] 1.15 to 1.89), high 1.13 (95% CI 0.98 to 1.31), and medium 1.02 (95% CI 0.91 to 1.15). Among 8,162 medical nonarrests, adjusted odds of survival were higher for patients intubated by rescuers with high and very high tracheal intubation experience; adjusted OR versus low tracheal intubation experience: very high 1.55 (95% CI 1.08 to 2.22), high 1.29 (95% CI 1.04 to 1.59), and medium 1.16 (95% CI 0.97 to 1.38). Among 3,202 trauma nonarrests, survival was not associated with rescuer tracheal intubation experience; adjusted OR versus low tracheal intubation experience: very high 1.84 (95% CI 0.89 to 3.81), high 1.25 (95% CI 0.85 to 1.85), and medium 0.92 (95% CI 0.67 to 1.26).
Conclusion
Rescuer procedural experience is associated with improved patient survival after out-of-hospital tracheal intubation of cardiac arrest and medical nonarrest patients. Rescuer procedural experience is not associated with patient survival after out-of-hospital tracheal intubation of trauma nonarrest patients.
doi:10.1016/j.annemergmed.2009.12.020
PMCID: PMC3071147  PMID: 20138400
6.  Identifying Risk for Attrition during Treatment for Depression 
Psychotherapy and Psychosomatics  2009;78(6):372-379.
Background
Understanding patients’ ambivalence about treatment persistence may be useful in tailoring retention interventions for individual patients with major depressive disorder.
Methods
Participants (n = 265) with major depressive disorder were enrolled into an 8-week trial with a selective serotonin reuptake inhibitor. At baseline and week 2, the participants were asked about their intent to return for the next visit, complete the study and continue in the study should they experience side effects or no improvement. Dropouts were defined as participants who discontinued attending clinic visits before completing the trial.
Results
Participants who at baseline reported an uncertain/negative intent to continue if they experienced side effects or no improvement dropped out at a significantly higher rate by weeks 6 and 8. Uncertain/negative intent at week 2 predicted attrition at all following visits. Dropouts without side effects were more likely to have reported an uncertain/negative intent to attend at both baseline and week 2, while dropouts who experienced side effects were more likely to have reported an uncertain/negative intent to attend only at baseline. Positive intent to continue was associated with greater symptom improvement in both dropouts and completers despite the possibility of lack of efficacy.
Conclusions
Participants’ pretreatment concerns about continuing antidepressant treatment in the presence of side effects signals challenges to the completion of a full 8-week acute phase treatment, even if the participant does not develop side effects. Individualized review of concerns and tailoring appropriate interventions may be necessary to reduce attrition.
doi:10.1159/000235977
PMCID: PMC2820313  PMID: 19738403
Attrition; Adherence; Depression; Antidepressant; Attitudes
7.  Gender Differences in Depression Symptoms in Treatment-Seeking Adults: STAR*D Confirmatory Analyses 
Comprehensive psychiatry  2008;49(3):238-246.
Background
While epidemiologic research consistently reports greater prevalence of major depressive disorder in women, small sample sizes in many studies do not allow for full elaboration of illness characteristics. This paper examines gender differences in terms of illness attributes in a cohort of 2541 outpatients from across the United States who enrolled in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study.
Method
Confirmatory analyses were performed in 2541 outpatients comparing men and women with regard to socio-demographic features, comorbid Axis I and Axis III conditions, and illness characteristics. Results were compared to those of our previous report on the initial population of the first 1500 individuals enrolled in STAR*D.
Results
In both samples, nearly two-thirds of the sample (62.5%) were women. Women had greater symptom severity, but men had more episodes of major depression, despite no difference in the length of illness. No differences in age of onset emerged. As in the first cohort, women showed greater rates of an anxiety disorder, bulimia and somatoform disorder, as well as more past suicide attempts, while men showed more alcohol and substance abuse. Women reported more appetite, weight, hypersomnia, interpersonal sensitivity, gastrointestinal and pain complaints, and less suicidal ideation. Irritability was equally common in men and women.
Conclusion
This large analysis confirmed most of the clinical features and co-morbidities found to be more prevalent in the first cohort of women. Additionally, this analysis corroborated previous research suggesting higher rates of atypical and anxious depression in women, but refuted the notion of an “irritable depression” found in men. The report confirmed the 1.7:1 ratio for depression seen across genders in the National Comorbidity Survey.
doi:10.1016/j.comppsych.2007.06.012
PMCID: PMC2759282  PMID: 18396182
Women; Depression; Prevalence; Gender
8.  Primary Versus Specialty Care Outcomes for Depressed Outpatients Managed with Measurement-Based Care: Results from STAR*D 
Background
Whether the acute outcomes of major depressive disorder (MDD) treated in primary (PC) or specialty care (SC) settings are different is unknown.
Objective
To compare the treatment and outcomes for depressed outpatients treated in primary versus specialty settings with citalopram in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study (www.star-d.org), a broadly inclusive effectiveness trial.
Design
Open clinical trial with citalopram for up to 14 weeks at 18 primary and 23 specialty sites. Participants received measurement-based care with 5 recommended treatment visits, manualized pharmacotherapy, ongoing support and guidance by a clinical research coordinator, the use of structured evaluation of depressive symptoms and side effects at each visit, and a centralized treatment monitoring and feedback system.
Participants
A total of 2,876 previously established outpatients in primary (n = 1091) or specialty (n = 1785) with nonpsychotic depression who had at least 1 post-baseline measure.
Measurements and Main Results
Remission (Hamilton Depression Rating Scale for Depression [Hamilton] or 16-item Quick Inventory of Depressive Symptomatology-Self-Rated [QIDS-SR16]); response (QIDS-SR16); time to first remission (QIDS-SR16). Remission rates by Hamilton (26.6% PC vs 28.0% SC, p = .40) and by QIDS-SR16 (32.5% PC vs 33.1% SC, p = .78) and response rates by QIDS-SR16 (45.7% PC vs 47.6% SC, p = .33) were not different. For those who reached remission or response at exit, the time to remission (6.2 weeks PC vs 6.9 weeks SC, p = .12) and to response (5.5 weeks PC vs 5.4 weeks SC, p = .97) did not differ by setting.
Conclusions
Identical remission and response rates can be achieved in primary and specialty settings when identical care is provided.
doi:10.1007/s11606-008-0522-3
PMCID: PMC2324144  PMID: 18247097
primary care; depression; clinical trial; outcomes
9.  Sex Differences in Response to Citalopram: A STAR*D Report 
Journal of psychiatric research  2008;43(5):503-511.
Objective
Controversy exists as to whether women with depression respond better to selective serotonin reuptake inhibitors (SSRIs) than men. The purpose of this report was to determine whether men and women differ in their responses to treatment with the SSRI citalopram using a large sample of real world patients from primary and psychiatric specialty care settings.
Method
As part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, 2876 participants were treated with citalopram for up to 12-14 weeks. Baseline demographic and clinical characteristics and outcomes were gathered and compared between men and women.
Results
At baseline, women were younger, had more severe depressive symptoms and were more likely to have: early onset; previous suicide attempt(s); a family history of depression, alcohol abuse or drug abuse; atypical symptom features; and one or more of several concurrent psychiatric disorders. Despite greater baseline severity and more Axis I comorbidities, women were more likely to reach remission and response with citalopram than men.
Conclusions
Women have a better response to the SSRI citalopram than men, which may be due to sex-specific biological differences particularly in serotonergic systems.
doi:10.1016/j.jpsychires.2008.07.002
PMCID: PMC2681489  PMID: 18752809
antidepressants; gender differences; estradiol; women's health; depression

Results 1-9 (9)