Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)

• Status: Completed
• Trial end date: 2014-09-05
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed study P06107.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Asenapine

Criteria

Inclusion Criteria:

• Completed study P06107 and demonstrated acceptable degree of compliance with medication, visits and other study requirements

• Must be male or a female who is not of childbearing potential and is not sexually active or is using a medically accepted method of contraception; or female who is not pregnant, or not lactating.

• Must have a caregiver or responsible person living with the participant who agrees to provide support to ensure compliance with treatment, visits, and protocol procedures

Exclusion Criteria:

• Positive pregnancy test or intention to become pregnant during the study

• At imminent risk of self-harm or harm to others

• Under involuntary inpatient commitment

• Known serological evidence of human immunodeficiency virus (HIV) antibody