Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
Status: | Recruiting |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 13 - 17 |
Updated: | 4/6/2019 |
Start Date: | August 23, 2017 |
End Date: | December 2022 |
A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents
with schizophrenia
with schizophrenia
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 schizophrenia.
and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a DSM-5 diagnosis
of schizophrenia.
Inclusion Criteria:
- 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, the current diagnosis of schizophrenia must be confirmed by the K-SADS-PL at
screening.
- Subjects who, in the investigator's judgment, require treatment with antipsychotic
medication(s).
Exclusion Criteria:
- 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
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