NCT01027559|CompletedResults
fMRI Study of Treatment Changes in Major Depression
fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes
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fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes
Sponsor study identifier
Secondary identifiers
interventional
97
1 country
1
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT) has the same healing effect on the brain for people with depression as traditional antidepressants do, and in comparison to healthy controls with no history of depression, to find out more about the causes of depression including differences in the extent of problems caused by depression. We hypothesize that CBT will have the same healing effect on the brain as antidepressants; that differences in brain activations created by the various tasks and genetic differences will help us understand differences in the type and severity of symptoms among the depressed subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 4, 2009
Actual (reported)December 8, 2009
Actual (reported)January 2014
Actual (reported)January 2014
Actual (reported)June 13, 2018
Actual (reported)Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.
baseline visit and 8-week follow-up
Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment.
Baseline and 12 weeks
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
Depressed participants randomized to receive the antidepressant sertraline (SRT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.
Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.
Washington University
St Louis, Missouri, 63110, United States
Yvette I Sheline, MD
University of Pennsylvania
Charles Conway, MD
Washington University School of Medicine
97 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2009
First Posted
December 8, 2009
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Cognitive Behavioral Therapy for Depression in Parkinson's Disease
Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.
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Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
July 17, 2018
Results First Posted
June 13, 2018
Record last verified: 2018-06
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