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

Primary Purpose

Chronic Depression

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

CBASP psychotherapy

Escitalopram

About this trial

This is an interventional treatment trial for Chronic Depression focused on measuring chronic depression, CBASP, Escitalopram, depression, trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Bonn, Dept. of PsychiatryRecruiting
University of Freiburg, Dept. of Psychiatry and PsychotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CBASP

Escitalopram

Arm Description

CBASP psychotherapy

Escitalopram pharmacotherapy and clinical management

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00837564

First Posted

February 4, 2009

Last Updated

June 29, 2010

Sponsor

University Hospital Freiburg

Collaborators

University Hospital, Bonn

1. Study Identification

Unique Protocol Identification Number

NCT00837564

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Freiburg

Collaborators

University Hospital, Bonn

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Depression

Keywords

chronic depression, CBASP, Escitalopram, depression, trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBASP

Arm Type

Experimental

Arm Description

CBASP psychotherapy

Arm Title

Escitalopram

Arm Type

Experimental

Arm Description

Escitalopram pharmacotherapy and clinical management

Intervention Type

Other

Intervention Name(s)

CBASP psychotherapy

Intervention Description

specific psychotherapy for chronic depression

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

28 weeks after ranomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claus Normann, MD

Organizational Affiliation

University of Freiburg, Dep. of Psychiatry

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dieter Schoepf, MD

Organizational Affiliation

University of Bonn, Clinic for Psychiatry and Psychotherapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Bonn, Dept. of Psychiatry

City

Bonn

ZIP/Postal Code

D-53105

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dieter Schoepf, MD

dieter.schoepf@ukb.uni-bonn.de

First Name & Middle Initial & Last Name & Degree

Dieter Schoepf, MD

First Name & Middle Initial & Last Name & Degree

Henrik Walter, MD, PhD

Facility Name

University of Freiburg, Dept. of Psychiatry and Psychotherapy

City

Freiburg

ZIP/Postal Code

D-79104

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claus Normann, MD

Phone

+49-761-2706501

claus.normann@uniklinik-freiburg.de

First Name & Middle Initial & Last Name & Degree

Claus Normann, MD

First Name & Middle Initial & Last Name & Degree

Elisabeth Schramm, PhD

12. IPD Sharing Statement

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

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