ong-Term Safety Extension Trial of Asenapine in Bipolar 1 DisorderParticipants Who Completed Protocol P05691 (P05692)

Conditions: Bipolar 1 Disorder
MedDRA version: 17.0Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2010-018410-78-BG

Lead Sponsor: Schering-Plough Research Institute, a Division of Schering

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 208
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to evaluate the long-term safety of 5 and 10 mg BID asenapine in bipolar subjects.;Secondary Objective: There are no secondary objectives.;Primary end point(s): Number of participants experiencing clinical and laboratory<br>adverse events (AEs);Timepoint(s) of evaluation of this end point: Baseline up to 212 days

Secondary Outcome Measures