Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897 AM2 EXT)

Status:	Completed
Conditions:	Schizophrenia
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	September 2010
End Date:	September 2013
Contact:	Toll Free Number
Phone:	1-888-577-8839

A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

This study is designed to evaluate whether asenapine, which is a US FDA-approved acute
treatment for schizophrenia in adults, is generally safe and well tolerated in adolescents
with schizophrenia. This is an extension of study to P05896, which means participants must
have completed participation in the 8-week study in order to qualify for this study.
Participants will receive open-label asenapine for 26 weeks. Throughout the study,
observations will be made on each participant at various times to assess the long-term
safety, tolerability and efficacy of the study treatment.

Inclusion Criteria:

- Each participant must be between 12 and 17 years of age at the time of entry on this
study, however, participants in the 8-week trial (P05896) who reach 18 years of age
while on P05896 may be enrolled in this extension study provided all other
inclusion/exclusion criteria are met.

- Must have completed the 8-week efficacy and safety trial (P05896) and, according to
the investigator's judgment, would benefit from long-term treatment.

- Must have demonstrated an acceptable degree of compliance with trial medication,
visits, and other requirements in the 8-week trial (P05896), in the opinion of the
investigator.

Exclusion Criteria:

- A female participant must not be pregnant and must not have the intention to become
pregnant during the trial.

- A participant must not be at imminent risk of self-harm or harm to others.

- A participant must not currently be under involuntary inpatient commitment.

We found this trial at

sites

Clinical Trial Facility in Colton California

Colton, California 92324

1118

from

Colton, CA