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Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

NCT ID: NCT01393613

Last Updated: 2015-11-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

674 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Detailed Description

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Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Conditions

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Acute Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 3 OPC 34712

Higher dose, tablet, once daily, for six weeks

Group Type EXPERIMENTAL

OPC-34712

Intervention Type DRUG

Higher dose tablet, once daily, for six weeks,

Dose 2 OPC 34712

Middle dose, tablet, once daily, for six weeks

Group Type EXPERIMENTAL

OPC-34712

Intervention Type DRUG

Middle dose tablet, once daily, for six weeks

Dose 1 OPC 34712

Lower dose, tablet, once daily, for six weeks

Group Type EXPERIMENTAL

OPC-34712

Intervention Type DRUG

Lower dose tablet, once daily, for six weeks

Placebo

Placebo, once daily, for six weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, once daily, for six weeks

Interventions

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OPC-34712

Higher dose tablet, once daily, for six weeks,

Intervention Type DRUG

OPC-34712

Middle dose tablet, once daily, for six weeks

Intervention Type DRUG

OPC-34712

Lower dose tablet, once daily, for six weeks

Intervention Type DRUG

Placebo

Placebo, once daily, for six weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms

Exclusion Criteria

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

* Schizoaffective disorder
* MDD
* Bipolar disorder
* Delirium, dementia, amnestic or other cognitive disorder
* Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksandar Skuban, M.D.

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

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Little Rock, Arkansas, United States

Site Status

Springdale, Arkansas, United States

Site Status

Escondido, California, United States

Site Status

Long Beach, California, United States

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Orange, California, United States

Site Status

Pico Rivera, California, United States

Site Status

San Diego, California, United States

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North Miami, Florida, United States

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North Miami, Florida, United States

Site Status

Overland Park, Kansas, United States

Site Status

Lake Charles, Louisiana, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Flowood, Mississippi, United States

Site Status

St Louis, Missouri, United States

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Buffalo, New York, United States

Site Status

Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

Site Status

Houston, Texas, United States

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Bogotá, , Colombia

Site Status

Medellín, , Colombia

Site Status

Pereira, , Colombia

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Rijeka, , Croatia

Site Status

Zagreb, , Croatia

Site Status

Zagreb, , Croatia

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Col. Florida, Mexico City, Mexico

Site Status

Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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San Luis Potosí City, San Luis Potos, Mexico

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Monterrey, , Mexico

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Cebu City, , Philippines

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Davano City, , Philippines

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Makati City, , Philippines

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Mandaluyong, , Philippines

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Manila, , Philippines

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Arkhangelsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

Site Status

Moscow Region, , Russia

Site Status

Nizhny Novgorod, , Russia

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Petrozavodsk, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Samara, , Russia

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Saratov, , Russia

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Tomsk, , Russia

Site Status

Village Nikolskoe, , Russia

Site Status

Bojnice, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Michalovace, , Slovakia

Site Status

Rimavská Sobota, , Slovakia

Site Status

Rožňava, , Slovakia

Site Status

Kaohsiung City, , Taiwan

Site Status

New Taipei City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Countries

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United States Colombia Croatia Mexico Philippines Russia Slovakia Taiwan

References

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Ismail Z, Kapadia S, Palma AM, Yildirim M, Farovik A. Brexpiprazole for anxiety symptoms in schizophrenia: a pooled analysis of short- and long-term trials. Curr Med Res Opin. 2025 Sep 11:1-14. doi: 10.1080/03007995.2025.2552286. Online ahead of print.

Reference Type DERIVED
PMID: 40859756 (View on PubMed)

Ismail Z, Meehan SR, Farovik A, Kapadia S, Palma AM, Zhang Z, McIntyre RS. Effects of brexpiprazole on patient life engagement in schizophrenia: post hoc analysis of Positive and Negative Syndrome Scale data. Curr Med Res Opin. 2025 Jan;41(1):145-153. doi: 10.1080/03007995.2024.2440059. Epub 2025 Jan 3.

Reference Type DERIVED
PMID: 39749727 (View on PubMed)

Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793.

Reference Type DERIVED
PMID: 35235720 (View on PubMed)

Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan.

Reference Type DERIVED
PMID: 34901863 (View on PubMed)

Newcomer JW, Eriksson H, Zhang P, Weiller E, Weiss C. Changes in metabolic parameters and body weight in brexpiprazole-treated patients with acute schizophrenia: pooled analyses of phase 3 clinical studies. Curr Med Res Opin. 2018 Dec;34(12):2197-2205. doi: 10.1080/03007995.2018.1498779. Epub 2018 Jul 27.

Reference Type DERIVED
PMID: 29985680 (View on PubMed)

Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.

Reference Type DERIVED
PMID: 27188270 (View on PubMed)

Kane JM, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, Eriksson H. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia. Schizophr Res. 2015 May;164(1-3):127-35. doi: 10.1016/j.schres.2015.01.038. Epub 2015 Feb 12.

Reference Type DERIVED
PMID: 25682550 (View on PubMed)

Other Identifiers

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331-10-230

Identifier Type: -

Identifier Source: org_study_id