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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: asenapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395992

P05692

2010-018410-78 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 2 patient groups

Asenapine 5 mg

Experimental group

Description:

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.

Treatment:

Drug: asenapine

Drug: asenapine

Asenapine 10 mg

Experimental group

Description:

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.

Treatment:

Drug: asenapine

Drug: asenapine