16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

ClinicalTrials.gov ID: NCT02389712

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Official title

16-week Open Randomized Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression: Pharmacogenomic and Biomarker Predictors of Response

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02389712
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 4
Lead sponsor: Mayo Clinic; Other
Enrollment: 2 participants

Conditions and interventions

Conditions

Bipolar Disorder

Interventions

Lamotrigine Drug
Fluoxetine Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2015 (Type not available)
Primary completion: May 23, 2018 (Actual)
Completion: May 23, 2018 (Actual)
Last update posted: Jun 19, 2019

2015 – 2018

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Mayo Clinic	Rochester	Minnesota	55905	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02389712, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 19, 2019 · Synced Nov 14, 2026