Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

Key facts

Study ID

NCT03198078

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

316

Starts

2017-06-30

Expected to finish

2023-04-03

Last updated by the study team

2023-12-20

Who can join

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

You may qualify if…

• Male \& female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
• PANSS score >= 80, inclusive, at screening and baseline

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 who have been hospitalized > 21 days for a current exacerbation of schizophrenia at the time of baseline.
• Any neurological disorder other than Tourette's Syndrome
• Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
• Subjects with epilepsy, a history of seizures, severe head trauma or stroke
• Subjects who test positive for drugs of abuse at screening

Where it is running

• For additional information regarding sites, contact 844-687-8522 — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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