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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Unknown status

CT.gov ID

NCT00596986

Collaborator

German Federal Ministry of Education and Research (Other)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Depression	Drug: Duloxetine Behavioral: Cognitive Behavioural Analysis System of Psychotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

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

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2009

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Neuroimaging Data (fMRI) [Before and After Therapy]

Secondary Outcome Measures

HAMD [Weekly]
Salivary Cortisol [Before and After Therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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