Treatment of Mild and Subthreshold Depressive Disorders

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00226642
• Collaborator: (none)
• Enrollment: 369
• Location: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Sertralin; Behavioral: Cognitive-behavioral therapy; Drug: Placebo; Behavioral: Non-specific supporting group therapy	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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")

Outcome Measures

Primary Outcome Measures

1. HAMD (changes between baseline and individual endpoint) []

2. IDS (changes between baseline and individual endpoint) []

Secondary Outcome Measures

1. BDI (changes between baseline and individual endpoint) []

2. CGI (changes between baseline and individual endpoint) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ludwig-Maximilians-University, Department of Psychiatry	Munich		Germany

Sponsors and Collaborators

• Ludwig-Maximilians - University of Munich

Investigators

• Principal Investigator: Ulrich Hegerl, Prof, MD, LMU, Department of Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00226642
• Other Study ID Numbers: KNDS-2.1
• First Posted: Sep 27, 2005
• Last Update Posted: Sep 27, 2005
• Last Verified: Feb 1, 2002

• Keywords provided by , ,: depression; primary care
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Sep 27, 2005