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

NCT ID: NCT01395992

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-01-31

Brief 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.

Conditions

Bipolar I Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Asenapine 5 mg

Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial.

Group Type: EXPERIMENTAL

asenapine

Intervention Type: DRUG

asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days

Asenapine 10 mg

Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study.

Group Type: EXPERIMENTAL

asenapine

Intervention Type: DRUG

asenapine 10 mg tablet, SL BID for 182 days

Interventions

asenapine

asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days

Intervention Type: DRUG

asenapine

asenapine 10 mg tablet, SL BID for 182 days

Intervention Type: DRUG

Other Intervention Names

Saphris®, SCH 900274, Org 5222, Sycrest®; Saphris®, SCH 900274, Org 5222, Sycrest®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Forest Investigative Site 1000

Austin, Texas, United States

Countries

United States

Other Identifiers

2010-018410-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05692

Identifier Type: -

Identifier Source: org_study_id