Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression (GETTY)
Primary Purpose
Chronic Depression
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Duloxetine
Cognitive Behavioural Analysis System of Psychotherapy
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Depression focused on measuring Depression, Duloxetine, Psychotherapy, Magnetic Resonance Imaging
Eligibility 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
Sites / Locations
- Charité Universitätsmedizin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AD
PT
Arm Description
Antidepressant Duloxetine
Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy
Outcomes
Primary Outcome Measures
Neuroimaging Data (fMRI)
Secondary Outcome Measures
HAMD
Salivary Cortisol
Full Information
NCT ID
NCT00596986
First Posted
January 8, 2008
Last Updated
July 31, 2009
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00596986
Brief Title
Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression
Acronym
GETTY
Official Title
Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Depression
Keywords
Depression, Duloxetine, Psychotherapy, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AD
Arm Type
Active Comparator
Arm Description
Antidepressant Duloxetine
Arm Title
PT
Arm Type
Active Comparator
Arm Description
Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine 30mg up to 120mg per day.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Analysis System of Psychotherapy
Intervention Description
Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.
Primary Outcome Measure Information:
Title
Neuroimaging Data (fMRI)
Time Frame
Before and After Therapy
Secondary Outcome Measure Information:
Title
HAMD
Time Frame
Weekly
Title
Salivary Cortisol
Time Frame
Before and After Therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Heuser, Prof. Dr. med. Dipl. Psych.
Organizational Affiliation
Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Colla, Dr. med.
Organizational Affiliation
Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression
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