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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00596986
First received: January 8, 2008
Last updated: July 31, 2009
Last verified: July 2009
History of Changes
  Purpose

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


Condition Intervention
Chronic Depression
 Drug: Duloxetine
Behavioral: Cognitive Behavioural Analysis System of Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Neuroimaging Data (fMRI) [ Time Frame: Before and After Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAMD [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Salivary Cortisol [ Time Frame: Before and After Therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596986

Locations
Germany
Charité Universitätsmedizin
Berlin, Germany, 14050
Sponsors and Collaborators
Charite University, Berlin, Germany
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
  More Information

No publications provided

Responsible Party: Dr. med. Michael Colla, Dept. of Psychiatry, Campus Benjamin Franklin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00596986     History of Changes
Other Study ID Numbers: EUK-B2.1, EUK-B2
Study First Received: January 8, 2008
Last Updated: July 31, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Depression
Duloxetine
Psychotherapy
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Duloxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on May 22, 2013