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NCT00787501 · ClinicalTrials.gov registry record · Phase 1
Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT00787501 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 98 participants.
The verdict
NCT00787501, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL CBT
- DRUG SSRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00787501
The ClinicalTrials.gov registry entry for NCT00787501 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CBT is the first listed.
NCT00787501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00787501 about?
NCT00787501 is a clinical study titled "Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression". 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) t...
What is the current status of trial NCT00787501?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2008-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00787501?
The interventions under investigation include: CBT (BEHAVIORAL), SSRI (DRUG).
Who is sponsoring clinical trial NCT00787501?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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