Brain Imaging of Psychotherapy for Depression

This study is ongoing, but not recruiting participants.

First Received: January 24, 2008 Last Updated: August 27, 2008 History of Changes

Sponsored by:	University of North Carolina
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00609453

Purpose

The goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fMRI), and to compare results to those obtained from a nondepressed control group.

Condition	Intervention
Major Depressive Disorder	Behavioral: Brief Behavioral Activation Treatment for Depression

MedlinePlus related topics: Depression MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Official Title:	Brain Imaging of Psychotherapy for Depression (Includes, "Reward System Recovery Following Behavioral Activation Therapy in Depression")

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Hamilton Depression Inventory [ Time Frame: three times over 12 weeks ] [ Designated as safety issue: No ]
Functional Magnetic Resonance Imaging [ Time Frame: twice in 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Individuals with major depressive disorder receiving therapy	Behavioral: Brief Behavioral Activation Treatment for Depression Weekly individual therapy sessions

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

For group 1: Diagnosis of current depression and no other current Axis I psychiatric disorder
For group 1: Hamilton Depression Rating Scale score of 15 or greater

Exclusion Criteria:

A history of serious head injury or neurological disease or psychosis
Current use of psychoactive medications
Factors that could affect MRI safety including current or planned pregnancy
For group 2: current Axis I psychiatric disorder, as assessed by structured clinical interview

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609453

Locations

United States, North Carolina
Duke-UNC Brain Imaging and Analysis Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

University of North Carolina

Investigators

Principal Investigator:

Gabriel S Dichter, PhD

The University of North Carolina, Chapel Hill

More Information

No publications provided

Responsible Party:	University of North Carolina at Chapel Hill ( Gabriel Dichter/Principal Investigator )
Study ID Numbers:	05-2605, NIMH R03 MH078145
Study First Received:	January 24, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00609453 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Control participants

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009