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Treatment of Mild and Subthreshold Depressive Disorders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Depression Drug: Sertralin Behavioral: Cognitive-behavioral therapy Drug: Placebo Behavioral: Non-specific supporting group therapy Phase 4

Study Type: Interventional
Study Design: 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 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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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 processed this record on September 21, 2017