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
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 30, 2010
July 1, 2010
1.2 years
February 4, 2009
June 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
8 weeks
Secondary Outcomes (1)
Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization
28 weeks after ranomization
Study Arms (2)
CBASP
EXPERIMENTALCBASP psychotherapy
Escitalopram
EXPERIMENTALEscitalopram pharmacotherapy and clinical management
Interventions
Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Freiburglead
- University Hospital, Bonncollaborator
Study Sites (2)
University of Bonn, Dept. of Psychiatry
Bonn, D-53105, Germany
University of Freiburg, Dept. of Psychiatry and Psychotherapy
Freiburg im Breisgau, D-79104, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus Normann, MD
University of Freiburg, Dep. of Psychiatry
- PRINCIPAL INVESTIGATOR
Dieter Schoepf, MD
University of Bonn, Clinic for Psychiatry and Psychotherapy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2011
Last Updated
June 30, 2010
Record last verified: 2010-07