NCT00609453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

January 24, 2008

Last Update Submit

October 5, 2012

Conditions

Major Depressive Disorder

Keywords

Control participants

Outcome Measures

Primary Outcomes (2)

  • Hamilton Depression Inventory

    three times over 12 weeks

  • Functional Magnetic Resonance Imaging

    twice in 12 weeks

Study Arms (1)

1

EXPERIMENTAL

Individuals with major depressive disorder receiving therapy

Behavioral: Brief Behavioral Activation Treatment for Depression

Interventions

Brief Behavioral Activation Treatment for DepressionBEHAVIORAL

Weekly individual therapy sessions

1

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-UNC Brain Imaging and Analysis Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Gabriel S Dichter, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

October 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations

US(1)