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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: Completed NA study, sponsored by Emory University.
NCT00367341 is a NA study that has completed, run by Emory University. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
\# of study participants with Hamilton Depression-17-item score less than or equal to 7.
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 |
What the finished NCT00367341 record still lists
NCT00367341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy (CBT) is the first listed.
NCT00367341 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00367341's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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