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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
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00226642
First received: September 23, 2005
Last updated: NA
Last verified: February 2002
History: No changes posted

September 23, 2005
September 23, 2005
Not Provided
Not Provided
  • HAMD (changes between baseline and individual endpoint)
  • IDS (changes between baseline and individual endpoint)
Same as current
No Changes Posted
  • BDI (changes between baseline and individual endpoint)
  • CGI (changes between baseline and individual endpoint)
Same as current
Not Provided
Not Provided
 
Treatment of Mild and Subthreshold Depressive Disorders
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")

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depression
  • Drug: Sertralin
  • Behavioral: Cognitive-behavioral therapy
  • Drug: Placebo
  • Behavioral: Non-specific supporting group therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
369
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00226642
KNDS-2.1
Not Provided
Not Provided
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Ulrich Hegerl, Prof, MD LMU, Department of Psychiatry
Ludwig-Maximilians - University of Munich
February 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP