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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Bonn
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00837564
First received: February 4, 2009
Last updated: June 29, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Chronic Depression
Other: CBASP psychotherapy
Drug: Escitalopram
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Depressive symptomatology after 8 weeks after randomization as measured by the MADRS [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization [ Time Frame: 28 weeks after ranomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837564

Locations
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
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

No publications provided

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
Study First Received: February 4, 2009
Last Updated: June 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
chronic depression
CBASP
Escitalopram
depression
trauma

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 18, 2014