Overview

This trial is active, not recruiting.

Condition depression
Treatments sertralin, cognitive-behavioral therapy, placebo, non-specific supporting group therapy
Phase phase 4
Sponsor Ludwig-Maximilians - University of Munich
Trial size 369 participants
Trial identifier NCT00226642, KNDS-2.1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
HAMD (changes between baseline and individual endpoint)
time frame:
IDS (changes between baseline and individual endpoint)
time frame:

Secondary Outcomes

Measure
BDI (changes between baseline and individual endpoint)
time frame:
CGI (changes between baseline and individual endpoint)
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Behandlung Von Leichten Und Unterschwelligen Depressionen. Eine Randomisierte, Kontrollierte Studie Zum Wirksamkeitsnachweis Eines Serotonin-Wiederaufnahme-Hemmers (SSRI), Einer Kognitiven Verhaltenstherapie Und Einer Freien Therapiewahl ("Treatment of Mild and Subthreshold Depressive Disorders". A Randomized, Controlled Trial on the Efficacy of a Serotonin-Reuptake-Inhibitor (SSRI), a Cognitive-Behavioral Therapy and of Free Choice Between SSRI and CBT")
Principal investigator Ulrich Hegerl, Prof, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.