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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596986
First Posted: January 17, 2008
Last Update Posted: August 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Charite University, Berlin, Germany
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Neuroimaging Data (fMRI) [ Time Frame: Before and After Therapy ]

Secondary Outcome Measures:
  • HAMD [ Time Frame: Weekly ]
  • Salivary Cortisol [ Time Frame: Before and After Therapy ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 8, 2008
First Posted: January 17, 2008
Last Update Posted: August 3, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Duloxetine Hydrochloride
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Agents