drugset / Trial / NCT00159783

40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

NCT00159783

Phase 3 Completed 218 enrolled Organon and Co Pfizer · collab
Non-randomizedParallel-groupQuadruple-blindTreatment

Summary

Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

Timeline

Start
2005-07
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Asenapine Other / unclassified 5 mg
Subject Asenapine Other / unclassified 10 mg
Comparator Olanzapine Small molecule 5 mg
Comparator Olanzapine Small molecule 20 mg

Indications