Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Bipolar II Disorder, Most Recent Episode Major Depressive
Interventions
DRUG

Lamotrigine

Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. For subjects in this combination therapy arm, antidepressant dose will remain constant throughout the study.

DRUG

Lamotrigine

Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. Subjects in this group will discontinue their antidepressants prescribed to them before the study.

Trial Locations (1)

Unknown

University of British Columbia Mood Disorders Centre, Vancouver

All Listed Sponsors
lead

University of British Columbia

OTHER

NCT00475137 - Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression | Biotech Hunter | Biotech Hunter