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

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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

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.

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
We found this trial at
3
sites
Rochester, New York 14618
Phone: 585-241-9670
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Rochester, NY
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Belgrade, 11000
Phone: 381 63 343 969
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Belgrade,
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New York, New York 10022
Phone: 646-678-4196
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New York, NY
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