NCT00837564

Cognitive Behavioural Analysis System of Psychotherapy (CBASp) Versus Escitalopram in Chronic Depression

Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Depression

Interventions

Type	Name	Description
OTHER	CBASP psychotherapy	specific psychotherapy for chronic depression
DRUG	Escitalopram	Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-04-01
• Completion: 2011-04-01
• First posted: 2009-02-05
• Last updated: 2010-06-30

Locations

2 sites across 1 country: Germany