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

PHASE4TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

May 23, 2018

Study Completion Date

May 23, 2018

Conditions
Bipolar Disorder
Interventions
DRUG

Lamotrigine

Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.

DRUG

Fluoxetine

Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed \> 40mg.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

J Willard and Alice S. Marriott Foundation

UNKNOWN

lead

Mayo Clinic

OTHER