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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Depression

Intervention / Treatment
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* Other: CBASP psychotherapy
* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptomatology after 8 weeks after randomization as measured by the MADRS |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization |  | 28 weeks after ranomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic depression, CBASP, Escitalopram, depression, trauma