ODS is a Naturalistic, Open Label, Non-randomized Follow-up Study on Depression and Related Substance Use Disorders (SUD). Study Targets: Efficacy of Psychosocial Treatment, Pharmacogenetics, Inflammation Related Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months
研究概览
简要总结
Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up study on depression and related substance use disorders (SUD). The study focuses on several aspects concerning the relation of depression and SUDs, the efficacy of selected assessment and treatment protocols, characteristics and genetics of the participants and the use of related biomarkers in clinical practice. The misused substance in focus is alcohol. In this study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the local ethics committee. Written informed consent was collected from all participants.
详细描述
Participants The participants were recruited in five outpatient clinics and in one psychiatric hospital ward in the South Ostrobothnia hospital district (population 200,000) during 1.10.2009 - 31.10.2013. Patients referred to psychiatric secondary services because of depressive symptoms, anxiety, self destructiveness, insomnia and alcohol or other substance related problems were screened with Beck depression inventory (BDI, version 1A). Patients with BDI score ≥ 17 at the screening phase were recruited in the study. The patients with a likely or verified psychotic disorders (ICD-10, F2*.** diagnosis) or organic brain disease were excluded.
A total of 242 patients were included in the study. Fifty-three (21.9%) patients were hospitalised at baseline. The participants were aged 17-64 years (mean 38.8 years, SD 12.2). Among the recruited were 148 females (61.2%) and 94 males (38.8%). The Mini International Neuropsychiatric Interview 5.0 (MINI) was made at the baseline to 219 patients.
At baseline 203 (84%) patients were prescribed antidepressive medication, 81% of cases either SSRI or SNRI as primary antidepressant). Antipsychotic medication was prescribed to 66 (28%) patients.
At the time of recruitment the participants were divided in two groups based on the AUDIT -score. The patients with baseline AUDIT-score ≥ 11 were categorized as patients with comorbid AUD and therefore dual diagnosis (DD+). The patients with AUDIT ≤ 10 were categorized as (DD-).
The clinical psychiatric evaluation was performed by a psychiatrist or other trained professional using the Mini International Neuropsychiatric Interview 5.0 (MINI). The symptoms of MDD were assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to psychiatric secondary services because of
- •Depressive symptoms
- •Self-destructiveness
- •Alcohol or other substance related problems, and had Beck depression inventory (BDI, version 1A) score at least 17 at the screening phase.
排除标准
- •A likely or verified ICD-10 F2 category diagnosis (psychotic disorders).
- •Organic brain disease
结局指标
主要结局
Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months
时间窗: baseline, 6 weeks, 6 months, 12 months, 24 months
Measure: MADRS depression scale
次要结局
- Change in severity of alcohol use from baseline at 6 weeks, 6 months, 12 months, and 24 months(baseline, 6 weeks, 6 months, 12 months, 24 months)
- Change in quality of life from baseline at 6 weeks, 6 months, 12 months, and 24 months(baseline, 6 months, 12 months, 24 months)
- Change in number of weekly consumed alcohol drinks from baseline at 6 weeks, 6 months, 12 months, and 24 months(baseline, 6 weeks, 6 months, 12 months, 24 months)
研究者
Olli Kampman
Associate Professor
Seinajoki Central Hospital
