Treatment of Mild and Subthreshold Depressive Disorders - Full Text View

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00226642

Purpose

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	Intervention	Phase
Depression	Drug: Sertralin Behavioral: Cognitive-behavioral therapy Drug: Placebo Behavioral: Non-specific supporting group therapy	Phase IV

MedlinePlus related topics: Depression

Drug Information available for: Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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")

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)

Secondary Outcome Measures:

BDI (changes between baseline and individual endpoint)
CGI (changes between baseline and individual endpoint)

Estimated Enrollment:

369

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226642

Locations

Germany
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

More Information

Study ID Numbers:	KNDS-2.1
Study First Received:	September 23, 2005
Last Updated:	September 23, 2005
ClinicalTrials.gov Identifier:	NCT00226642
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

depression
primary care

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder
Serotonin
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009