NCT00764478View on ClinicalTrials.gov

Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

PHASE3CompletedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

April 6, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

May 28, 2014

Conditions
Bipolar 1 Disorder
Interventions
DRUG

Asenapine

asenapine tablet, 5 mg sublingually BID for 21 days

DRUG

Asenapine

asenapine tablet, 10 mg sublingually BID for 21 days

DRUG

Placebo

placebo sublingual tablet, administered BID for 21 days

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00764478 - Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) | Biotech Hunter | Biotech Hunter