Clinical trial NCT00837564: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Depression
Keywords: chronic depression
CBASP
Escitalopram
depression
trauma
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: University Hospital, Bonn
First posted: 2009-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
timeFrame: 8 weeks
Secondary outcomes:
measure: Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization
timeFrame: 28 weeks after ranomization
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Dept. of Psychiatry
city: Freiburg
country: Germany
facility: University of Freiburg, Dept. of Psychiatry and Psychotherapy
Study officials:
affiliation: University of Freiburg, Dep. of Psychiatry
name: Claus Normann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bonn, Clinic for Psychiatry and Psychotherapy
name: Dieter Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References: