40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Bipolar Disorder
Interventions
DRUG

Asenapine

Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks

DRUG

Placebo

Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00145509 - 40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786) | Biotech Hunter | Biotech Hunter