Cognitive Behavioural Analysis System of Psychotherapy (CBASp) Versus Escitalopram in Chronic Depression
Information source: University Hospital Freiburg
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Depression
Intervention: CBASP psychotherapy (Other); Escitalopram (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital Freiburg Official(s) and/or principal investigator(s):
Claus Normann, MD, Principal Investigator, Affiliation: University of Freiburg, Dep. of Psychiatry
Dieter Schoepf, MD, Principal Investigator, Affiliation: University of Bonn, Clinic for Psychiatry and Psychotherapy
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.
Clinical Details
Official title: Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
Secondary outcome: Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
University of Bonn, Dept. of Psychiatry, Bonn D-53105, Germany; Recruiting
Dieter Schoepf, MD, Email: dieter.schoepf@ukb.uni-bonn.de
Dieter Schoepf, MD, Principal Investigator
Henrik Walter, MD, PhD, Sub-Investigator
University of Freiburg, Dept. of Psychiatry and Psychotherapy, Freiburg D-79104, Germany; Recruiting
Claus Normann, MD, Phone: +49-761-2706501, Email: claus.normann@uniklinik-freiburg.de
Claus Normann, MD, Principal Investigator
Elisabeth Schramm, PhD, Sub-Investigator
Additional Information
Starting date: February 2009
Last updated: June 29, 2010
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