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

NCT ID: NCT00596986

Last Updated: 2009-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AD

Antidepressant Duloxetine

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Duloxetine 30mg up to 120mg per day.

PT

Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Analysis System of Psychotherapy

Intervention Type BEHAVIORAL

Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.

Interventions

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Duloxetine

Duloxetine 30mg up to 120mg per day.

Intervention Type DRUG

Cognitive Behavioural Analysis System of Psychotherapy

Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Psychiatry, Campus Benjamin Franklin, Charite University, Berlin, Germany

Principal Investigators

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Isabella Heuser, Prof. Dr. med. Dipl. Psych.

Role: STUDY_CHAIR

Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany

Michael Colla, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany

Locations

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Charité Universitätsmedizin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EUK-B2

Identifier Type: -

Identifier Source: secondary_id

EUK-B2.1

Identifier Type: -

Identifier Source: org_study_id

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