NCT00159796

3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

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 7501005 (Secondary Title: ARES)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Asenapine	Asenapine, 3 weeks
DRUG	Olanzapine	Olanzapine, 3 weeks
DRUG	Placebo	placebo, 3 weeks

Timeline

• Start date: 2004-12-14
• Primary completion: 2006-03-28
• Completion: 2006-04-28
• First posted: 2005-09-12
• Last updated: 2024-08-15