Treatment of Mild and Subthreshold Depressive Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2002 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Information provided by:
Ludwig-Maximilians - University of Munich Identifier:
First received: September 23, 2005
Last updated: NA
Last verified: February 2002
History: No changes posted

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 Intervention Phase
Drug: Sertralin
Behavioral: Cognitive-behavioral therapy
Drug: Placebo
Behavioral: Non-specific supporting group therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 NLM:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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
  More Information

No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00226642     History of Changes
Other Study ID Numbers: KNDS-2.1
Study First Received: September 23, 2005
Last Updated: September 23, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Serotonin Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents processed this record on November 27, 2015