Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

Bipolar I Disorder Clinical Trial

Official title:

A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395992
• Other study ID #: P05692
• Secondary ID: 2010-018410-78
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: May 26, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial Summary

Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment

• Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691

Exclusion criteria:

• A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial

• A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691

• A participant must not be at imminent risk of self-harm or harm to others

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• asenapine
asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
• asenapine
asenapine 10 mg tablet, SL BID for 182 days

Locations

Country	Name	City	State
United States	Forest Investigative Site 1000	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing clinical and laboratory adverse events (AEs)		Baseline up to 212 days	No