3 Week Clinical Trial comparing Asenapine to Placebo Treatment followed by an optional 50 weeks of Active Asenapine Treatment (CHR #11-07598)
Description This clinical trial will compare the safety and effectiveness of Asenapine to placebo.
Each participant will take part in the trial for up to 65 days and will be given either study medication or a placebo (inactive substance). Participants will be evaluated each week through approximately eight clinic visits.Participants will then have the option of joining a 50‐week extension of the study in which all participants will receive study medication.
The study doctor and study staff can more fully explain the specific details of what study participants must do while participating in this study.
End Date 12/31/2014
- 10-17 years of age
- Generally healthy
- Diagnosed with bipolar disorder with current manic or mixed episodes with or without psychotic features.
Payment Patricipants will receive a stipend of $40 for attending each clinic visit.