Status:
COMPLETED
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
Lead Sponsor:
Organon and Co
Conditions:
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and...
Eligibility Criteria
Inclusion
- 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 base study (P05896 \[NCT01190254\]) 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 \[NCT01190254\]) 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 \[NCT01190254\]), in the opinion of the investigator.
Exclusion
- 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.
Key Trial Info
Start Date :
September 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2013
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01190267
Start Date
September 28 2010
End Date
October 7 2013
Last Update
May 22 2024
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