Treatment of Mild and Subthreshold Depressive Disorders

Depression Clinical Trial

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")

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00226642
• Other study ID #: KNDS-2.1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 23, 2005
• Last updated: September 23, 2005

Study information

• Verified date: February 2002
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 369
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Sertralin

Behavioral:
• Cognitive-behavioral therapy

Drug:
• Placebo

Behavioral:
• Non-specific supporting group therapy

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians-University, Department of Psychiatry	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD (changes between baseline and individual endpoint)
Primary	IDS (changes between baseline and individual endpoint)
Secondary	BDI (changes between baseline and individual endpoint)
Secondary	CGI (changes between baseline and individual endpoint)