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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Depression
• Intervention / Treatment: Other: CBASP psychotherapy; Drug: Escitalopram

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, D-53105
    • Recruiting
    • University of Bonn, Dept. of Psychiatry
    • Contact: Dieter Schoepf, MD; Email: dieter.schoepf@ukb.uni-bonn.de
    • Principal Investigator: Dieter Schoepf, MD
    • Sub-Investigator: Henrik Walter, MD, PhD
  • Freiburg, Germany, D-79104
    • Recruiting
    • University of Freiburg, Dept. of Psychiatry and Psychotherapy
    • Contact: Claus Normann, MD; Phone Number: +49-761-2706501; Email: claus.normann@uniklinik-freiburg.de
    • Principal Investigator: Claus Normann, MD
    • Sub-Investigator: Elisabeth Schramm, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: February 4, 2009
• First Posted (Estimate): February 5, 2009

Study Record Updates

• Last Update Posted (Estimate): June 30, 2010
• Last Update Submitted That Met QC Criteria: June 29, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: trauma; depression; Escitalopram; CBASP; chronic depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: CBASP-1