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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02389712
The ClinicalTrials.gov registry entry for NCT02389712 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine is the first listed.
NCT02389712 reports 0 study locations.
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.
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