3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
Status:
Completed
Trial end date:
2006-04-28
Target enrollment:
Participant gender:
Summary
Bipolar disorder is characterized by mood swings that range 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. This is a 3-week study that will test the safety and efficacy
of this medication. Participants will receive either asenapine, olanzapine (a medication that
is already approved for the treatment of bipolar mania), or placebo (no active medication).
Participants will be required to stay in the hospital for at least the first seven days of
treatment. Participants who complete the 3 week study may be eligible to continue in
extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.