fMRI Study of Treatment Changes in Major Depression

Browse trials for

• Depression 8,057
• Depressive Disorder 4,845
• Depressive Disorder, Major 2,741

Keywords

• Major Depression
• Functional Magnetic Resonance Imaging
• Emotional Circuitry
• Cognitive Behavioral Therapy

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 97 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Eligibility criteria

Study arms

• Active comparator
  Depressed Group: CBT

  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.

  Behavioral: Cognitive Behavioral Therapy

• No intervention
  Healthy Control Group

  Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.

• Active comparator
  Depressed Group: SRT

  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.

  Drug: Sertraline

Interventions

• DrugSertraline

  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.

  Also known as: SRT

• BehavioralCognitive Behavioral Therapy

  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.

  Also known as: CBT

Primary outcomes

1. 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.

   Time frame: baseline visit and 8-week follow-up

2. 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.

   Time frame: Baseline and 12 weeks

Baseline characteristics