Status:
ACTIVE_NOT_RECRUITING
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
Detailed Description
This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophreni...
Eligibility Criteria
Inclusion
- Male \& female subjects 13-17 years of age, inclusive.
- Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
- Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.
- Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).
Exclusion
- Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening
- Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).
- History of failure of clozapine treatment or response to clozapine treatment only.
- History of neuroleptic malignant syndrome
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2025
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT03238326
Start Date
August 23 2017
End Date
August 5 2025
Last Update
May 15 2025
Active Locations (57)
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1
Clinical Research Site #101
Dothan, Alabama, United States, 36303
2
Clinical Research Site #128
Anaheim, California, United States, 92805
3
Clinical Research Site #105
Culver City, California, United States, 90230
4
Clinical Research Site #103
Long Beach, California, United States, 90807