Lamotrigine for Symptoms of Geriatric Bipolar Depression

PHASE3CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Bipolar DisorderDepression, Bipolar
Interventions
DRUG

Lamotrigine regular tablet formulation

Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.

DRUG

Lamotrigine novel formulation

"Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used.~Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds."

Trial Locations (5)

10605

Weill Medical College of Cornell University, White Plains

15213

University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh

19104

University of Pennsylvania, Philadelphia

44106

University Hospitals Case Medical Center/ Case Western Reserve University, Cleveland

77030

Baylor College of Medicine/Michael E. DeBakey VAMC, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

University Hospitals Cleveland Medical Center

OTHER