Anxiety Disorders Clinical Trial
— ODSOfficial title:
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
Verified date | August 2015 |
Source | Seinajoki Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 242 |
Est. completion date | June 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years to 65 Years |
Eligibility |
Inclusion Criteria: Patients referred to psychiatric secondary services because of 1. Depressive symptoms 2. Anxiety 3. Self-destructiveness 4. Insomnia 5. Alcohol or other substance related problems, and had Beck depression inventory (BDI, version 1A) score at least 17 at the screening phase. Exclusion Criteria: - A likely or verified ICD-10 F2 category diagnosis (psychotic disorders). - Organic brain disease |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Finland | Seinäjoki Hospital District | Seinäjoki | South Ostrobothnia |
Lead Sponsor | Collaborator |
---|---|
Seinajoki Central Hospital | University of Tampere |
Finland,
Kampman O, Lassila A. Samanaikaisen mielenterveys- ja päihdeongelman hoitoon on kehitetty integroitu arviointimalli [TI: An Integrated Assessment Method for Dual Diagnosis]. Suom Lääkäril 2007:4447-4451.[SO: Finnish Medical Journal, Finnish]
Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010 Aug;30(6):608-20. Review. — View Citation
Rollnick S, Miller WR. What is motivational interviewing? Behavioural and Cognitive Psychotherapy. 1995;23:325-334.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months | Measure: MADRS depression scale | baseline, 6 weeks, 6 months, 12 months, 24 months | No |
Secondary | Change in quality of life from baseline at 6 weeks, 6 months, 12 months, and 24 months | Measure: 15D scale | baseline, 6 months, 12 months, 24 months | No |
Secondary | 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 | No | |
Secondary | Change in severity of alcohol use from baseline at 6 weeks, 6 months, 12 months, and 24 months | Measure: AUDIT (Alcohol Use Disorders Identification Test) | baseline, 6 weeks, 6 months, 12 months, 24 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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