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Clinical Trials/NCT00226642
NCT00226642
Unknown
Phase 4

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")

Ludwig-Maximilians - University of Munich1 site in 1 country369 target enrollmentSeptember 27, 2005

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Depression
Sponsor
Ludwig-Maximilians - University of Munich
Enrollment
369
Locations
1
Primary Endpoint
HAMD (changes between baseline and individual endpoint)
Last Updated
20 years ago

Overview

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.

Hypotheses:

  • SSRI is superior to placebo
  • CBT is superior to a non-specific supporting group therapy
Registry
clinicaltrials.gov
Start Date
September 27, 2005
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
  • informed consent

Exclusion Criteria

  • severe mood disorders
  • bipolar disorder
  • recurrent brief depression
  • suicidality
  • alcohol or drug dependency
  • obsessive-compulsive disorder
  • schizoaffective disorder / schizophrenia
  • pregnancy

Outcomes

Primary Outcomes

HAMD (changes between baseline and individual endpoint)

IDS (changes between baseline and individual endpoint)

Secondary Outcomes

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

Study Sites (1)

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