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

Chronic Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00837564
• Other study ID #: CBASP-1
• Status: Recruiting
• Phase: Phase 3
• First received: February 4, 2009
• Last updated: June 29, 2010
• Start date: February 2009
• Est. completion date: April 2011

Study information

• Verified date: July 2010
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic MDD according to DSM-IV (modification: depressive symptomatology for at least one year), or recurrent MDE (third or greater episode with the immediately preceding episode being no more than 2.5 years before the onset of the present episode)

• Age 18-65

• Score of at least 18 on the Montgomery-Asberg-Rating Scale for Depression (MADRS)

Exclusion Criteria:

• Acute risk for suicide

• History of psychotic symptoms, bipolar disorder or dementia

• Severe substance-related abuse or dependence disorder

• Schizotypal, antisocial or borderline personality disorder

• Serious medical condition

• Severe cognitive impairment

• Absence of a response to previous adequate trial of the study medication/CBASP

• Hypersensitivity to Escitalopram

• Treatment with a MAO-inhibitor within 1 week before the initiation of study treatment

Study Design

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

Related Conditions & MeSH terms

• Chronic Depression
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Germany	University of Bonn, Dept. of Psychiatry	Bonn
Germany	University of Freiburg, Dept. of Psychiatry and Psychotherapy	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptomatology after 8 weeks after randomization as measured by the MADRS		8 weeks	Yes
Secondary	Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization		28 weeks after ranomization	Yes