Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression (GETTY)

July 31, 2009 updated by: Charite University, Berlin, Germany

Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias

The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Charité Universitätsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic Depression (Double Depression, Chronic MDE, MDE with incomplete remission)
  • HAMD-24>20

Exclusion Criteria:

  • Concurrent Psychotherapy or Psychopharmacotherapy
  • Previous Non-Response to Duloxetine
  • Non-Response to three Antidepressants of two different groups given at adequate doses or Non-Response to two empirically tested forms of Psychotherapy in the current Depressive Episode
  • Serious Psychiatric comorbidity
  • Serious Neurologic comorbidity
  • Contraindications to Duloxetine
  • Contraindications to fMRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AD
Antidepressant Duloxetine
Drug: Duloxetine
Duloxetine 30mg up to 120mg per day.
ACTIVE_COMPARATOR: PT
Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy
Behavioral: Cognitive Behavioural Analysis System of Psychotherapy
Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuroimaging Data (fMRI)
Time Frame: Before and After Therapy
Before and After Therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
HAMD
Time Frame: Weekly
Weekly
Salivary Cortisol
Time Frame: Before and After Therapy
Before and After Therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Study Chair: Isabella Heuser, Prof. Dr. med. Dipl. Psych., Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
  • Principal Investigator: Michael Colla, Dr. med., Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2009

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 8, 2008

First Posted (ESTIMATE)

January 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2009

Last Update Submitted That Met QC Criteria

July 31, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUK-B2.1
  • EUK-B2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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