Extension Study of Asenapine {P06107 (NCT01244815)} for Pediatric Bipolar Disorder (P05898 AM3)
Status: | Completed |
---|---|
Conditions: | Psychiatric, Bipolar Disorder |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | June 2011 |
End Date: | August 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P05898)
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 (NCT01244815).
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 or who is not pregnant,
not lactating, and is using a medically accepted method of contraception
- 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
We found this trial at
62
sites
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