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NCT02389712 · ClinicalTrials.gov registry record · Phase 4
16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression
A Phase 4 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT02389712: Clinical Trial Phase 4 study, sponsored by Mayo Clinic.
NCT02389712 is a Phase 4 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02389712, a Phase 4 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to have a better understanding of whether individuals with a particular gene type and other inherited biological markers will have a good response to fluoxetine or lamotrigine, or alternatively, would be more likely to have side effects to this medication.
Interventions
- DRUG Lamotrigine
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-05-23 |
| Phase | Phase 4 |
Why NCT02389712 stopped before completion
NCT02389712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine is the first listed.
NCT02389712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02389712 about?
NCT02389712 is a clinical study titled "16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression". The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to have a better understanding of whether individuals with a particular gene type and other inherited biological ma...
What is the current status of trial NCT02389712?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2015-03. Estimated completion is 2018-05-23.
What interventions are being tested in trial NCT02389712?
The interventions under investigation include: Lamotrigine (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT02389712?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02389712's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 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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