- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609453
Brain Imaging of Psychotherapy for Depression
October 5, 2012 updated by: Gabriel Dichter, University of North Carolina, Chapel Hill
Brain Imaging of Psychotherapy for Depression (Includes, "Reward System Recovery Following Behavioral Activation Therapy in Depression")
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke-UNC Brain Imaging and Analysis Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Individuals with major depressive disorder receiving therapy
|
Weekly individual therapy sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hamilton Depression Inventory
Time Frame: three times over 12 weeks
|
three times over 12 weeks
|
|
Functional Magnetic Resonance Imaging
Time Frame: twice in 12 weeks
|
twice in 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gabriel S Dichter, PhD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Estimate)
October 8, 2012
Last Update Submitted That Met QC Criteria
October 5, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-2605
- NIMH R03 MH078145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.