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.

Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale)

Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated.

The Readiness for Discharge Questionaire (RDQ) was administered to characterize the subject's readiness for discharge. The investigator was to make the decision about discharging the subject.

SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered.

The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint..

The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms

Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded.

Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline.

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.

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