Treatment of Mild and Subthreshold Depressive Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226642
Recruitment Status : Unknown
Verified February 2002 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
First Posted : September 27, 2005
Last Update Posted : September 27, 2005
Information provided by:
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.


  • 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 Type : Interventional  (Clinical Trial)
Enrollment : 369 participants
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")

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226642

Ludwig-Maximilians-University, Department of Psychiatry
Munich, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Principal Investigator: Ulrich Hegerl, Prof, MD LMU, Department of Psychiatry

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00226642     History of Changes
Other Study ID Numbers: KNDS-2.1
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: September 27, 2005
Last Verified: February 2002

Keywords provided by Ludwig-Maximilians - University of Munich:
primary care

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators