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NCT02137369 · ClinicalTrials.gov registry record · Phase 4
The ISLAND Study: InSuLa Assessed Needs for Depression
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 77
- Enrollment target
NCT02137369 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 77 participants.
The verdict
NCT02137369, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 77 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. The goal of this study is to test how brain function changes in depress patients treated with cognitive behavioral therapy (CBT) compared to patients treated with a selective serotonin reuptake inhibitor (SSRI, either escitalopram or sertraline), which are FDA approved antidepressants. The study aims to determine if bran scan findings might help physicians to select the most effective antidepressant treatment for an individual patient. Up to 100 male and female outpatients who are between 21-55 years old will be enrolled. Participation in the study will last from 14-26 weeks. Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks. Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance imaging (fMRI) scans will be done before the treatment begins, and again at the end of treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an additional 12 weeks of treatment with the alternative intervention.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- DRUG Selective serotonin re-uptake inhibitor
- OTHER Combination treatment (SSRI + CBT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2014-09 |
| Est. Completion | 2019-10-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02137369
The ClinicalTrials.gov registry entry for NCT02137369 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 77 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 3 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT02137369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02137369 about?
NCT02137369 is a clinical study titled "The ISLAND Study: InSuLa Assessed Needs for 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. The goal of this study is to test how brain function changes in depres...
What is the current status of trial NCT02137369?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 77 participants. The study started on 2014-09. Estimated completion is 2019-10-24.
What interventions are being tested in trial NCT02137369?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Selective serotonin re-uptake inhibitor (DRUG), Combination treatment (SSRI + CBT) (OTHER).
Who is sponsoring clinical trial NCT02137369?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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