Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression (ssrifMRI)
Recruitment status was Recruiting
Our goals are 1) to use functional magnetic resonance imaging (fMRI) to predict which depressed individuals will respond to different validated treatments for unipolar depression including Cognitive Therapy (CT) and antidepressant medications (selective serotonin reuptake inhibitors; SSRIs) and 2) to understand whether CT and SSRIs affect similar aspects of brain function underlying cognition and emotion. Thus, we will examine depressed adults ages 18-55 using fMRI during cognitive and emotional information processing tasks, before and after treatment with an SSRI (n=25) or CT (n=40). We hypothesize that: 1) Recovery will occur in treatment with an SSRI primarily for individuals with increased reactivity in limbic brain regions associated with emotion generation and prefrontal regions associated with regulation,. 2) Recovery with CT will occur for patients with increased activity in brain regions associated with emotion generation but decreased activity in prefrontal regions associated with emotion regulation. 3) Recovery with an SSRI will yield similar changes in brain function to CT in brain regions associated with emotion generation but less change in brain regions responsible for emotion regulation such as the prefrontal cortex. Findings from this study may have a profound impact on reducing the burden of clinical depression by providing evidenced-based diagnostic and treatment guidelines.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression|
- Treatment outcome will be assessed on a variety of dimensions including change in symptoms, self-reported rumination, behavioral performance on cognitive tasks, and physiological reactivity to emotional information processing tasks. [ Time Frame: 14-16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Active Comparator: SSRIs
Selective Serotonin Reuptake Inhibitors
SSRI: 25 patients will receive 14 weeks of an FDA approved selective serotonin reuptake inhibitor (SSRI), administered under the supervision of a staff psychiatrist. After an initial 30-45 minute session patients will be seen for 15-30 minute sessions for 16-20 sessions over 14 weeks. Medication will begin with 10mg escitalopram daily (or its equivalent), increased to 30 mg/day (or its equivalent) by week 6 if pt has not achieved a minimum level of response (i.e., CGI < 2) and tolerability is adequate. Nonresponse at week 10 (CGI < 2) will be cause for medication switch or augmentation.
Active Comparator: CBT
Cognitive Behavior Therapy
Cognitive Behavior Therapy: 40 patients will receive 16- 20 60 minute sessions of procedurally determined Cognitive Therapy (Beck, 1979) over 14 weeks. Patients will begin with 2 sessions per week which may be reduced to once per week in the latter part of the study period if the patient is responding to the therapy. Cognitive Therapy is designed to teach skills that help to reduce depressive severity. Each session will be videotaped and will include homework to be completed and brought to the following session.
Same as above.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787501
|Contact: Susan R Bermanfirstname.lastname@example.org|
|Contact: Agnes E Haggertyemail@example.com|
|United States, Pennsylvania|
|Mood Disorders Treatment and Research Program - UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Susan R Berman 412-246-6111 firstname.lastname@example.org|
|Contact: Agnes E Haggerty 412-383-5443 email@example.com|
|Sub-Investigator: Edward S Friedman|
|Sub-Investigator: Robert H Howland, M.D.|
|Sub-Investigator: Timothy Denko, M.D.|
|Sub-Investigator: Duane Spiker, M.D.|
|Sub-Investigator: Michael Thase, M.D.|
|Principal Investigator:||Greg J Siegle, PhD||University of Pittsburgh|