NCT01807741

Asenapine for Bipolar Depression

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks. We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.

Detailed description

86 patients with an episode of major depression associated with bipolar disorder, type I will be recruited by two sites for the study over fifteen months. Medication will be administered in a double-blind manner. Patients will receive asenapine (or placebo) beginning on day 0 at 5 mg bid. Dose may be increased to 10 mg bid and adjusted based on clinical response. Patients will be evaluated by a blinded (to treatment status) rater. Patients will be seen and ratings obtained at baseline (day 0) and on days 7, 14, 28, 42, and 56 (or termination from the study). Adverse events will be evaluated as well.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Asenapine	Available in 5 and 10 mg.
DRUG	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2013-03-08
• Last updated: 2017-07-24

Locations

1 site across 1 country: United States