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")
ConditionsDepression
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
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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