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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609453
Other study ID # 05-2605
Secondary ID NIMH R03 MH07814
Status Completed
Phase N/A
First received January 24, 2008
Last updated October 5, 2012
Start date October 2006
Est. completion date January 2008

Study information

Verified date October 2012
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Behavioral:
Brief Behavioral Activation Treatment for Depression
Weekly individual therapy sessions

Locations

Country Name City State
United States Duke-UNC Brain Imaging and Analysis Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Inventory three times over 12 weeks No
Primary Functional Magnetic Resonance Imaging twice in 12 weeks No
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