MedDataX Logo

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

NCT ID: NCT00837564

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chronic depression CBASP Escitalopram depression trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBASP

CBASP psychotherapy

Group Type EXPERIMENTAL

CBASP psychotherapy

Intervention Type OTHER

specific psychotherapy for chronic depression

Escitalopram

Escitalopram pharmacotherapy and clinical management

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBASP psychotherapy

specific psychotherapy for chronic depression

Intervention Type OTHER

Escitalopram

Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bonn

OTHER

Sponsor Role collaborator

University Hospital Freiburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Freiburg, Dep. of Psychiatry, Germany

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claus Normann, MD

Role: PRINCIPAL_INVESTIGATOR

University of Freiburg, Dep. of Psychiatry

Dieter Schoepf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn, Clinic for Psychiatry and Psychotherapy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Bonn, Dept. of Psychiatry

Bonn, , Germany

Site Status RECRUITING

University of Freiburg, Dept. of Psychiatry and Psychotherapy

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dieter Schoepf, MD

Role: primary

Claus Normann, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CBASP-1

Identifier Type: -

Identifier Source: org_study_id