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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole; Drug: Brexpiprazole (OPC-34712); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198078

2017-001447-12 (EudraCT Number)

331-10-234

Details and patient eligibility

About

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

Full description

This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Enrollment: 316 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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316 participants in 3 patient groups, including a placebo group

Brexpiprazole

Experimental group

Description:

Participants were administered with brexpiprazole oral tablets, daily, dose titrated up to 0.5 mg by Day 4, 1 mg by Day 7, 2 mg by Day 14, then between 2-4 mg after Day 21 up to Week 6 with a 1 mg increase or decrease, based on the Investigator's decision.

Treatment:

Drug: Brexpiprazole (OPC-34712)

Aripiprazole

Active Comparator group

Description:

Participants were administered with aripiprazole oral tablets, daily, dose titrated up to 2 mg by Day 4, 5 mg by Day 7, 10 mg by Day 14, then 10, 15 or 20 mg after Day 21 up to Week 6 with a 5 mg increase or decrease, based on the Investigator's decision.

Treatment:

Drug: Aripiprazole

Placebo

Placebo Comparator group

Description:

Participants were administered with brexpiprazole or aripiprazole matching placebo oral tablets, daily up to Week 6.

Treatment:

Drug: Placebo