Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression

PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

October 31, 2007

Study Completion Date

February 29, 2008

Conditions
Bipolar Disorder
Interventions
DRUG

Divalproex Sodium ER

Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

DRUG

Placebo

. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

Trial Locations (1)

44106

University Hospitals of Cleveland, Cleveland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

University Hospitals Cleveland Medical Center

OTHER