Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.

PHASE3TerminatedINTERVENTIONAL
Enrollment

237

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

March 31, 2020

Study Completion Date

May 20, 2020

Conditions
Bipolar I Disorder
Interventions
DRUG

Escitalopram

"Escitalopram will be prescribed in the dose range 10-30 mg daily.~In patients randomized to the 8-week group:~* escitalopram will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of escitalopram (or matching placebo) may be decreased in 10 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 10-30 mg daily at all time points.~Patients randomized to the 52 week arm will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study."

DRUG

Bupropion XL

"Bupropion XL will be prescribed in the dosage range 150-450 mg daily.~In patients randomized to the 8-week group:~* bupropion XL will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of bupropion XL (or matching placebo) may be decreased in 150 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 150-450 mg daily at all time points.~Patients randomized to the 52 week arm will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study."

Trial Locations (1)

V6T 2A1

University of British Columbia, Vancouver

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Lundbeck Canada Inc.

INDUSTRY

collaborator

Lupin Limited

INDUSTRY

lead

University of British Columbia

OTHER

NCT00958633 - Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. | Biotech Hunter | Biotech Hunter