3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)

A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501004 (Secondary Title: ARES)

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. Patients will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Patients will be required to stay in the hospital for at least the first seven days of treatment. Patients that complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.

Inclusion Criteria:

• Have a DSMIV diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

• Patients with unstable medical conditions or clinically significant laboratory abnormalities or patients who are rapid cyclers (ie. have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.