Treatment of Mild and Subthreshold Depressive Disorders

Phase 4

• Conditions: Depression

• Registration Number: NCT00226642
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression.

Hypotheses:

* SSRI is superior to placebo

* CBT is superior to a non-specific supporting group therapy

Detailed Description

Not available

Study Timeline

• Status Verified: 2002-02
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Last Update Submitted: 2005-09-23
• Study First Posted: 2005-09-27
• Last Update Posted: 2005-09-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

(e.g.)

• subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
• informed consent
• 18 years

Exclusion Criteria

(e.g.)

• severe mood disorders
• bipolar disorder
• recurrent brief depression
• suicidality
• alcohol or drug dependency
• obsessive-compulsive disorder
• schizoaffective disorder / schizophrenia
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)

Secondary Outcome Measures

Name	Time	Method
CGI (changes between baseline and individual endpoint)
BDI (changes between baseline and individual endpoint)

Trial Locations

Locations (1)

Ludwig-Maximilians-University, Department of Psychiatry; 🇩🇪 Munich, Germany