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

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ClinicalTrials.gov Identifier: NCT00837564
Recruitment Status : Unknown
Verified July 2010 by University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : February 5, 2009
Last Update Posted : June 30, 2010
Sponsor:
Collaborator:
University Hospital, Bonn
Information provided by:
University Hospital Freiburg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Depression Other: CBASP psychotherapy Drug: Escitalopram Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma
Study Start Date : February 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CBASP
CBASP psychotherapy
 Other: CBASP psychotherapy
specific psychotherapy for chronic depression
Experimental: Escitalopram
Escitalopram pharmacotherapy and clinical management
 Drug: Escitalopram
Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management


Outcome Measures
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Primary Outcome Measures :
  1. Depressive symptomatology after 8 weeks after randomization as measured by the MADRS [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization [ Time Frame: 28 weeks after ranomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837564


Locations
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Germany
University of Bonn, Dept. of Psychiatry Recruiting
Bonn, Germany, D-53105
Contact: Dieter Schoepf, MD       dieter.schoepf@ukb.uni-bonn.de   
Principal Investigator: Dieter Schoepf, MD         
Sub-Investigator: Henrik Walter, MD, PhD         
University of Freiburg, Dept. of Psychiatry and Psychotherapy Recruiting
Freiburg, Germany, D-79104
Contact: Claus Normann, MD    +49-761-2706501    claus.normann@uniklinik-freiburg.de   
Principal Investigator: Claus Normann, MD         
Sub-Investigator: Elisabeth Schramm, PhD         
Sponsors and Collaborators
University Hospital Freiburg
University Hospital, Bonn
Investigators
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Principal Investigator: Claus Normann, MD University of Freiburg, Dep. of Psychiatry
Principal Investigator: Dieter Schoepf, MD University of Bonn, Clinic for Psychiatry and Psychotherapy
More Information
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Responsible Party: Dr. Claus Normann, University of Freiburg, Dep. of Psychiatry, Germany
ClinicalTrials.gov Identifier: NCT00837564     History of Changes
Other Study ID Numbers: CBASP-1
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: July 2010
Keywords provided by University Hospital Freiburg:
chronic depression
CBASP
Escitalopram
depression
trauma
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
 Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents