NCT00143182

9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

A Double-Blind, 9-Week Extension Study Evaluating the Safety and Maintenance of Effect of Asenapine vs. Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501006 (Secondary Title: ARES)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (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. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Asenapine	Asenapine , 9 weeks
DRUG	Olanzapine	Olanzapine, 9 weeks

Timeline

• Start date: 2005-01-07
• Primary completion: 2006-06-28
• Completion: 2006-06-28
• First posted: 2005-09-02
• Last updated: 2024-08-15