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临床试验/NCT02520271
NCT02520271已完成不适用

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

Seinajoki Central Hospital2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2009年10月1日最近更新:
适应症

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

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

发起方
Seinajoki Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olli Kampman

Associate Professor

Seinajoki Central Hospital

研究点 (2)

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