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

Sponsor

University Hospital Freiburg (Other)

Overall Status

Unknown status

CT.gov ID

NCT00837564

Collaborator

University Hospital, Bonn (Other)

Enrollment

Locations

Arms

25.9

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Depression	Other: CBASP psychotherapy Drug: Escitalopram	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBASP CBASP psychotherapy	Other: CBASP psychotherapy specific psychotherapy for chronic depression
Experimental: Escitalopram Escitalopram pharmacotherapy and clinical management	Drug: Escitalopram Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management

Arm

Intervention/Treatment

Experimental: CBASP

CBASP psychotherapy

Other: CBASP psychotherapy

specific psychotherapy for chronic depression

Experimental: Escitalopram

Escitalopram pharmacotherapy and clinical management

Drug: Escitalopram

Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management

Outcome Measures

Primary Outcome Measures

Depressive symptomatology after 8 weeks after randomization as measured by the MADRS [8 weeks]

Secondary Outcome Measures

Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization [28 weeks after ranomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bonn, Dept. of Psychiatry	Bonn		Germany	D-53105
2	University of Freiburg, Dept. of Psychiatry and Psychotherapy	Freiburg		Germany	D-79104

Sponsors and Collaborators

University Hospital Freiburg
University Hospital, Bonn

Investigators

Principal Investigator: Claus Normann, MD, University of Freiburg, Dep. of Psychiatry
Principal Investigator: Dieter Schoepf, MD, University of Bonn, Clinic for Psychiatry and Psychotherapy