Flexible Dose, Long-term Safety Study of Asenapine for the Treatmentof Schizophrenia in Adolescents (P05897 AM1) (ADDRESS-97)
- Conditions
- Health Condition 1: null- Schizophrenia, ParanoidSchizophrenia, DisorganizedSchizophrenia, UndifferentiatedHealth Condition 2: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2012/02/002403
- Lead Sponsor
- Merck Sharp and Dohme Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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 investigators 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of long-term asenapine treatment in adolescentsTimepoint: Through Week 26, plus a minimum of a 30-day follow up
- Secondary Outcome Measures
Name Time Method To Collect exploratory efficacy data of long-term treatment with asenapine in adolescents (12 to 17 years of age) with Schizophrenia <br/ ><br>Timepoint: Through Week 26, plus a minimum of a 30-day <br/ ><br>follow up