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

NCT03198078 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 331-10-2342017-001447-12
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Brexpiprazole; Schizophrenia; Adolescent

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) to 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value and baseline visit interaction as a covariate, and with an unstructured covariance.

  Baseline to Week 6

Secondary Outcomes (21)

• Change From Baseline to Week 6 in PANSS Positive and Negative Sub-Scales Scores

  Baseline to Week 6

• Percentage of Participants Achieving Response

  Up to 6 weeks

• Percentage of Participants Achieving Remission

  Up to 6 weeks

• Change From Baseline to Week 6 in Children's Global Assessment Scale (CGAS) Total Score

  Baseline to Week 6

• Change From Baseline to Week 6 in Clinical Global Impression Severity (CGI-S) Scale Score

  Baseline to Week 6

Study Arms (3)

Brexpiprazole

EXPERIMENTAL

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.

Drug: Brexpiprazole (OPC-34712)

Aripiprazole

ACTIVE COMPARATOR

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.

Drug: Aripiprazole

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Brexpiprazole (OPC-34712) DRUG

Once-daily, tablets

Brexpiprazole

Aripiprazole DRUG

Once-daily, tablets

Aripiprazole

Placebo DRUG

Once-daily, tablets

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

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

Oklahoma City, Oklahoma, 73116, United States

Location

Related Publications (1)

• 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.

  PMID: 40209740 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Study Officials

• Caroline Ward, PhD.

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety \& efficacy

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: June 30, 2017
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-11

Locations

US (1)