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

NCT ID: NCT03198078

Last Updated: 2023-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2023-04-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia

Keywords

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Brexpiprazole Schizophrenia Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety \& efficacy
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Brexpiprazole

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.

Group Type EXPERIMENTAL

Brexpiprazole (OPC-34712)

Intervention Type DRUG

Once-daily, tablets

Aripiprazole

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.

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Once-daily, tablets

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once-daily, tablets

Interventions

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Brexpiprazole (OPC-34712)

Once-daily, tablets

Intervention Type DRUG

Aripiprazole

Once-daily, tablets

Intervention Type DRUG

Placebo

Once-daily, tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Ward, PhD.

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

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For additional information regarding sites, contact 844-687-8522

Oklahoma City, Oklahoma, United States

Site Status

Countries

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Serbia Spain Ukraine United States

References

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Ward C, Pejovic Milovancevic M, Kohegyi E, Hefting N, Aurang C, Chen D, Larsen KG, Hobart M, Correll CU. Efficacy and safety of brexpiprazole in adolescents with schizophrenia: a multicountry, randomised, double-blind, placebo-controlled, phase 3 trial with an active reference. Lancet Psychiatry. 2025 May;12(5):345-354. doi: 10.1016/S2215-0366(25)00043-4. Epub 2025 Apr 7.

Reference Type DERIVED
PMID: 40209740 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-001447-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

331-10-234

Identifier Type: -

Identifier Source: org_study_id