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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: Completed Phase 4 study, sponsored by Emory University.
NCT02137369 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 77 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.
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 |
What the finished NCT02137369 record still lists
NCT02137369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT02137369 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02137369's enrollment target sits among peer trials
77 989th of 2000 higher than 1,007 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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