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1.  Depressive attribution style and stressor uncontrollability increase perceived pain intensity after electrical skin stimuli in healthy young men 
Depressive and pain symptoms often occur concurrently in patients with psychiatric disorders or somatic diseases, but the contribution of pre-existing dysfunctional cognitive schemata to pain perception remains unclear.
To investigate the relationship between depression-related attribution styles and perceived pain intensity (PPI) after controllable versus uncontrollable electrical skin stimulation in healthy male individuals.
Causal attributions for negative events were measured using the attribution style questionnaire (ASQ) on the dimensions internal versus external (INT), global versus specific (GLO) and stable versus unstable (STA) in 50 men (20 to 31 years of age). Additionally, symptoms of anxiety and depression (measured using the Depression Scale) as well as baseline helplessness were assessed. Participants were randomly assigned to receive self-administered (controllable) or experimenter-administered (uncontrollable) painful skin stimuli. PPI was assessed after stress exposure using a visual analogue scale (0 to 100). Relationships between PPI and depression-related cognitions were calculated using correlation and multiple regression analyses.
Correlation analyses revealed a moderate correlation between PPI and ASQ-INT scores (r=0.46). Following uncontrollable stress exposure, significantly higher PPI ratings (P=0.001) and a higher correlation between PPI and ASQ-INT (r=0.70) were observed. Multiple regression analysis showed an independent influence of stressor controllability (ß=0.39; P=0.003) and ASQ-INT (ß=0.36; P=0.006) on PPI.
These findings highlight the interaction of specific depression-related cognitions and stress controllability on pain intensity perception.
The results of the present study may facilitate understanding of the cognitive aspects of pain intensity perception and improve psychological pain therapies focusing on attributions and controllability.
PMCID: PMC3812192  PMID: 23717827
Attribution styles; Controllability; Pain intensity
2.  Clinical Practice Associated with a Switch from and to Ziprasidone during Routine Inpatient Treatment of Patients with Schizophrenia 
Ziprasidone (ZIP) shows a low propensity for metabolic side effects but can prolong QTc time. It is unclear how these features translate into clinical reality. Charts of inpatients with schizophrenia and switched from (ZIP − , n = 27) or to ZIP (ZIP + , n = 24) were reviewed. Clinical data including documented switch reasons were anonymously analyzed. Comorbidity, body mass index (BMI) at admission, illness severity, side effects, illness duration, and length of stay were comparable in both groups. About 2/3 of ZIP+ were women (1/3 of ZIP − , P = 0.035); ZIP+ patients were younger (P = 0.017), had higher BMI values (P = 0.042), and received higher chlorpromazine equivalents before switch (P = 0.004) whereas ZIP doses were comparable (136 versus 141 mg/d). More patients in ZIP− versus ZIP+ were switched because of previous weight gain (P = 0.006) and depression (P = 0.085) whereas single reasons for ZIP− versus ZIP+ were mainly persisting positive symptoms (P = 0.089) and patients' choice (P = 0.10). The results of the naturalistic study corroborate controlled trials.
PMCID: PMC3420656  PMID: 22937263
3.  Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus 
BMC Psychiatry  2013;13:206.
Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes.
This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase.
The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression.
The study is investigator initiated and was supported by the ‘Förderprogramm Klinische Studien (Clinical Trials)’ and the ‘Competence Network for Diabetes mellitus’ funded by the Federal Ministry of Education and Research (FKZ 01KG0505).
Trial registration
Current controlled trials ISRCTN89333241.
PMCID: PMC3750698  PMID: 23915015
4.  Serum Levels After Everolimus-Stent Implantation and Paclitaxel-Balloon Angioplasty in an Infant with Recurrent Pulmonary Vein Obstruction After Repaired Total Anomalous Pulmonary Venous Connection 
Pediatric Cardiology  2011;32(7):1036-1039.
Everolimus-eluting stents and paclitaxel-coated balloons are used in the interventional treatment of coronary artery disease in adults to reduce the restenosis rate and in small-vessel disease. Both substances are released into the circulation. We report systemic drug exposure after implantation of one everolimus-eluting stent and dilation with one paclitaxel-coated balloon in an 8-month-old infant, which was used as an innovative therapy for recurrent pulmonary vein stenosis.
PMCID: PMC3174384  PMID: 21796444
Pulmonary venous obstruction; Everolimus stent; Paclitaxel balloon; Total anomalous pulmonary venous connection
5.  Helplessness and perceived pain intensity: relations to cortisol concentrations after electrocutaneous stimulation in healthy young men 
Uncontrollable aversive events are associated with feelings of helplessness and cortisol elevation and are suitable as a model of depression. The high comorbidity of depression and pain symptoms and the importance of controllability in both conditions are clinically well-known but empirical studies are scarce. The study investigated the relationship of pain experience, helplessness, and cortisol secretion after controllable vs. uncontrollable electric skin stimulation in healthy male individuals.
Sixty-four male volunteers were randomly assigned to receive 30 controllable (self-administered) or uncontrollable (experimenter-administered) painful electric skin stimuli. Perceived pain intensity (PPI), subjective helplessness ratings, and salivary cortisol concentrations were assessed. PPI was assessed after stress exposure. For salivary cortisol concentrations and subjective helplessness ratings, areas under the response curve (AUC) were calculated.
After uncontrollable vs. controllable stress exposure significantly higher PPI ratings (P = 0.023), higher subjective helplessness AUC (P < 0.0005) and higher salivary cortisol AUC (P = 0.004, t-tests) were found. Correlation analyses revealed a significant correlation between subjective helplessness AUC and PPI (r = 0.500, P < 0.0005), subjective helplessness AUC and salivary cortisol AUC (r = 0.304, P = 0.015) and between PPI and salivary cortisol AUC (r = 0.298, P = 0.017).
The results confirm the impact of uncontrollability on stress responses in humans; the relationship of PPI with subjective helplessness and salivary cortisol suggests a cognitive-affective sensitization of pain perception, particularly under uncontrollable conditions.
PMCID: PMC3141369  PMID: 21718526
6.  Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA) 
BMC Geriatrics  2010;10:21.
The global prevalence of diabetes among adults will be 6.4% in 2010 and will increase to 7.7% by 2030. Diabetes doubles the odds of depression, and 9% of patients with diabetes are affected by depressive disorders. When subclinical depression is included, the proportion of patients who have clinically relevant depressive symptoms increases to 26%. In patients aged over 65 years, the interaction of diabetes and depression has predicted increased mortality, complications, disability, and earlier occurrence of all of these adverse outcomes. These deleterious effects were observed even in minor depression, where the risk of mortality within 7 years was 4.9 times higher compared with diabetes patients who did not have depressive symptoms. In this paper we describe the design and methods of the Minor Depression and Diabetes trial, a clinical trial within the 'Competence Network for Diabetes mellitus', which is funded by the German Federal Ministry of Education and Research.
Patients' inclusion criteria are: Type 2 diabetes mellitus, 65 to 85 years of age, 3 to 6 depressive symptoms (minor depression or mild major depression). Our aim is to compare the efficacy of diabetes-specific cognitive behavioural therapy adapted for the elderly vs. intensified treatment as usual vs. a guided self-help intervention regarding improvement of health related quality of life as the primary outcome. The trial will be conducted as a multicentre, open, observer-blinded, parallel group (3 groups) randomized controlled trial. Patients will be randomized to one of the three treatment conditions. After 12 weeks of open-label therapy in all treatment conditions, both group interventions will be reduced to one session per month during the one-year long-term phase of the trial. At the one-year follow-up, all groups will be re-examined regarding the primary and secondary parameters, for example reduction of depressive symptoms, prevention of moderate/severe major depression, improvement of glycaemic control, mortality, and cost effectiveness. Depending on additional funding, the sample will be continuously observed as a prospective cohort; the primary outcome will be changed to mortality for all subsequent follow-up measurements.
Trial registration
Current Controlled Trials Register (ISRCTN58007098).
PMCID: PMC2877665  PMID: 20441572
7.  Cost-effectiveness analysis of cognitive behaviour therapy for treatment of minor or mild-major depression in elderly patients with type 2 diabetes: study protocol for the economic evaluation alongside the MIND-DIA randomized controlled trial (MIND-DIA CEA) 
BMC Geriatrics  2009;9:25.
Depression and elevated depression symptoms are more prevalent in patients with type 2 diabetes than in those without diabetes and are associated with adverse health outcomes and increased total healthcare utilization. This suggests that more effective depression treatment might not only improve health outcome, but also reduce costs. However, there is a lack of evidence on (cost-) effectiveness of treatment options for minor and mild-major depression in patients with type 2 diabetes. In this paper we describe the design and methods of the economic evaluation, which will be conducted alongside the MIND-DIA trial (Cognitive behaviour therapy in elderly type 2 diabetes patients with minor or mild-major depression). The objective of the economic evaluation (MIND-DIA CEA) is to examine incremental cost-effectiveness of a diabetes specific cognitive behaviour group therapy (CBT) as compared to intensified treatment as usual (TAU) and to a guided self-help group intervention (SH).
Patients will be followed for 15 months. During this period data on health sector costs, patient costs and societal productivity/time costs will be collected in addition to clinical data. Person-years free of moderate/severe major depression, quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial (CBT, TAU and SH). To determine cost-effectiveness of the CBT, differences in costs and effects between the CBT group and TAU/SH group will be calculated.
CBT is a potentially effective treatment option to improve quality of life and to avoid the onset of a moderate/severe major depression in elderly patients with type 2 diabetes and minor or mild-major depression. This hypothesis will be evaluated in the MIND-DIA trial. Based on these results the associated economic evaluation will provide additional evidence on the cost-effectiveness of CBT in this target population. Methodological strengths and weaknesses of the planned economic evaluation are discussed.
Trial registration
The MIND-DIA study has been registered at the Current Controlled Trials Register (ISRCTN58007098).
PMCID: PMC2709652  PMID: 19570236
8.  Association analysis between variants of the interleukin-1β and the interleukin-1 receptor antagonist gene and antidepressant treatment response in major depression 
This study investigated the possible association of the interleukin-1 beta (IL-1β) C-511T promoter polymorphism and the interleukin-1 receptor antagonist (IL-1Ra) (86bp)n variable number of tandem repeats (VNTR) polymorphism with antidepressant response to paroxetine and mirtazapine treatment. The study group consisted of 101 patients suffering from DSM-IV major depression participating in a randomized double-blind controlled clinical trial. Patients homozygous for the IL-1β-511T allele had a significantly faster and more pronounced response to paroxetine treatment than IL-1β-511C allele carriers. No association was found for the IL-1β C-511T polymorphism with mirtazapine treatment response. The IL-1Ra VNTR showed neither an association with paroxetine nor with mirtazapine treatment response. Our results provide further suggestive evidence that time course of response and antidepressant efficacy of paroxetine, but not of mirtazapine, is influenced in a clinically relevant manner by the IL-1β C-511T gene variant. Our data do not support the hypothesis that the IL-1Ra (86bp)n VNTR affects antidepressant treatment response to paroxetine or mirtazapine. An independent replication of our finding is needed. If replicated, the IL-1β C-511T promoter polymorphism could be considered useful for prospective confirmatory pharmacogenetic trials in patients with major depression.
PMCID: PMC2515903  PMID: 18728809
major depression; antidepressive agents; treatment outcome; interleukin-1 beta; interleukin-1 receptor antagonist; genetic polymorphisms

Results 1-8 (8)