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NCT00367341 · ClinicalTrials.gov registry record · NA
Imaging Predictors of Treatment Response in Depression
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT00367341 is a NA study that has completed, run by Emory University. The registered enrollment target is 82 participants.
The verdict
NCT00367341, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study Summary
While there are many effective options for treating a major depressive episode, there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy. More critically, there are also no reliable predictors that might anticipate failure to such standard treatments either alone or in combination. This project will characterize imaging-based brain subtypes that distinguish groups of depressed patients who later remit or not to SSRI pharmacotherapy or cognitive behavior therapy (CBT), respectively. To define these subtypes, a prospectively-treated cohort of 100 patients will be randomized to receive either escitalopram (s-CIT) or CBT for the first 12 weeks, with non-remitters to either first treatment crossed over to receive an additional 12 weeks of treatment with combined treatment. Non-remitters to both treatments will thus define a relatively treatment resistant third subgroup. Resting-state 18F-fluoro-deoxyglucose (FDG) positron emission tomography (PET) scans will be acquired prior to initiating antidepressant therapy, with pre-treatment scan patterns associated with three possible outcomes (CBT remission, s-CIT remission, and non-remission to both) assessed using multivariate analytic methods. A second PET scan, acquired early in the treatment course, will be used to assess the likelihood of response to the specific treatment first assigned. The proposed studies are a first step towards defining brain-based biomarkers predictive of differential treatment outcome in major depression; most critically, patterns distinguishing patients at risk for treatment resistance. Identification of such biomarkers has additional implications for future testing of novel therapies in patients with distinct brain signatures, including development of evidence-based treatment algorithms for individual patients.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- DRUG escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2006-08 |
| Est. Completion | 2013-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00367341
The ClinicalTrials.gov registry entry for NCT00367341 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy (CBT) is the first listed.
NCT00367341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00367341 about?
NCT00367341 is a clinical study titled "Imaging Predictors of Treatment Response in Depression". While there are many effective options for treating a major depressive episode, there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy. More critically, there are also no reliable predictors that might anti...
What is the current status of trial NCT00367341?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2006-08. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00367341?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), escitalopram (DRUG).
Who is sponsoring clinical trial NCT00367341?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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