Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia

NCT05325645 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 331-102-00062
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia

Conditions

Acute Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at last visit of the double-blind period

  Baseline and Week 7

Study Arms (2)

Brexpiprazole QW 48mg

EXPERIMENTAL

Brexpiprazole QW 48mg, tablet, once weekly, for seven weeks(Initial dose Brexpiprazole QW 24mg)

Drug: OPC-34712FUM/ Brexpiprazole fumarate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OPC-34712FUM/ Brexpiprazole fumarate DRUG

2 brexpiprazole QW tablets 24 mg (48 mg/dose) will be orally administered once weekly for 7weeks.(As an initial dose, one brexpiprazole QW tablet 24 mg and one placebo tablet will be orally administered (24 mg/dose))

Brexpiprazole QW 48mg

Placebo DRUG

Two placebo tablets will be orally administered once weekly for 7weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients at least 18 years of age and below the age of 65 at the time of informed consent
• Patients with a diagnosis of schizophrenia based on DSM-5® (295.90) (multiple episodes, currently in acute episode) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) at the time of informed consent
• Patients who are hospitalized, or judged to require hospitalization, for acute relapse of schizophrenia at the time of informed consent
• Patients whose current episode developed within 2 months prior to screening
• Patients who were treated with antipsychotics at appropriate doses for appropriate durations for the most recent acute episode and who are considered to have responded to the antipsychotics (excluding clozapine)
• Patients who experienced a recurrence or exacerbation of symptoms during an antipsychotic-free period
• Patients who have been fully informed of and understand the objectives, procedures, risks, and expected medicinal benefits of the trial and are able to provide written informed consent prior to initiation of any trial-related procedures

You may not qualify if:

• \<Regarding indication\>
• Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
• Patients who are considered resistant/refractory to antipsychotic treatment Patients who are "unresponsive to medication with 2 or more antipsychotics at effective doses for a sufficiently long duration (6 weeks)" will be deemed resistant/refractory to antipsychotic treatment.
• Patients who have a history of treatment with clozapine for schizophrenia
• Patients experiencing acute depressive symptoms within 30 days prior to informed consent that, in the judgment of the investigator, require treatment with an antidepressant
• Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior
• Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment)
• Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment)
• Patients who present a serious risk of suicide based on the judgment of the investigator
• Patients presenting tardive dyskinesia at the time of informed consent, as determined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormal movements) of the AIMS at screening or at baseline
• Patients with a score of 5 (severe akathisia) in the BARS global clinical assessment of akathisia at screening or at baseline
• Patients who meet either of the following criteria between 30 days before screening and the start of screening\*
• Not including the start date of screening
• Received 2 or more antipsychotics, each at doses equivalent to ≥ 600 mg/day of chlorpromazine
• Received a mean daily dose equivalent to \> 800 mg/day\*\*,\*\*\* of chlorpromazine

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (1)

Hayakawa Clinic

Kure-shi, Japan

RECRUITING

Study Officials

• Takeshi Tsunoda

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

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

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: July 21, 2022
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)