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Clinical Trial Summary

60 patients with chronic major depressive disorder according to DSM-IV will be included into the study. Patients will be randomized to receive an open treatment either with CBASP, a psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28 weeks.


Clinical Trial Description

The psychotherapeutic treatment with CBASP will be conducted in 2 weekly sessions for the first 4 weeks, one per week thereafter until week 9, followed by one session every 2 weeks for 20 more weeks. The starting dose for Escitalopram will be 10 mg/d for one week and will be increased to 20 mg/d after one week. The dosage can be reduced to 10 mg/d after day 7 to improve tolerance. Th MADRS-scale is the primary outcome measure; ratings will be performed by a blinded rater. If there is no improvement (reduction of less than 20% of the MADRS), patients will be crossed over in terms of adding the other treatment at week 8. Study patients will be asked to participate in fMRI, genetic and pharmacological substudies. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00837564
Study type Interventional
Source University Hospital Freiburg
Contact
Status Recruiting
Phase Phase 3
Start date February 2009
Completion date April 2011

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00596986 - Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression N/A
Completed NCT02470988 - Does Disciplined Personal Involvement Precede Change in CBASP? N/A
Completed NCT05221567 - Intensive Psychotherapy for Chronic Depression N/A
Completed NCT00006172 - Clinical Trials of Two Non-drug Treatments for Chronic Depression N/A
Recruiting NCT05833087 - Schema Therapy for Patients With Chronic Treatment Resistant Depression N/A