Bipolar I Disorder
Conditions
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.
Interventions
DRUGasenapine
asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Baseline up to 212 days |
Countries
United States
Outcome results
None listed