Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Key facts

Study ID

NCT03238326

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

295

Starts

2017-08-23

Expected to finish

2025-04-22

Last updated by the study team

2026-02-04

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Clinical Research Site #128 — Anaheim, California, United States
• Clinical Research Site #105 — Culver City, California, United States
• Clinical Research Site #103 — Long Beach, California, United States
• Clinical Research Site #136 — Atlanta, Georgia, United States
• Clinical Research Site #148 — Kansas City, Kansas, United States
• Clinical Research Site #138 — Lake Charles, Louisiana, United States
• Clinical Research Site #124 — Las Vegas, Nevada, United States
• Clinical Research Site #130 — New York, New York, United States
• Clinical Research Site #100 — Rochester, New York, United States
• Clinical Research Site #121 — Kinston, North Carolina, United States
• Clinical Research Site #133 — Cincinnati, Ohio, United States
• Clinical Research Site #113 — Garfield Heights, Ohio, United States
• Clinical Research Site #102 — Oklahoma City, Oklahoma, United States
• Clinical Research Site #135 — Tulsa, Oklahoma, United States
• Clinical Research Site #140 — Frisco, Texas, United States
• Clinical Research Site #108 — Everett, Washington, United States
• Clinical Research Site #321 — Nice, France
• Clinical Research Site #283 — Naples, Italy
• Clinical Research Site #163 — León, Guanajuato, Mexico
• Clinical Research Site #165 — Guadalajara, Jalisco, Mexico
• Clinical Research Site #171 — Monterrey, Nuevo León, Mexico
• Clinical Research Site #160 — Monterrey, Nuevo León, Mexico
• Clinical Research Site #170 — San Luis Potosí City, San Luis Potosí, Mexico
• Clinical Research Site #161 — Culiacán, Sinaloa, Mexico
• Clinical Research Site #101 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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