Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

NCT ID: NCT01396421

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 636 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Detailed Description

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

Acute Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OPC-34712 [Brexpiprazole] High Dose

Higher Dose, tablet, once daily, for six weeks

Group Type: EXPERIMENTAL

OPC-34712 [Brexpiprazole] High Dose

Intervention Type: DRUG

Higher dose, tablet, once daily, for six weeks

OPC-34712 [Brexpiprazole] Middle Dose

Middle Dose, tablet, once daily, for six weeks

Group Type: EXPERIMENTAL

Experimental: OPC-34712 [Brexpiprazole] Middle Dose

Intervention Type: DRUG

Middle dose, tablet, once daily, for six weeks

OPC-34712 [Brexpiprazole] Low Dose

Lower Dose, tablet, once daily, for six weeks

Group Type: EXPERIMENTAL

Experimental: OPC-34712 [Brexpiprazole] Low Dose

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

OPC-34712 [Brexpiprazole] High Dose

Higher dose, tablet, once daily, for six weeks

Intervention Type: DRUG

Experimental: OPC-34712 [Brexpiprazole] Middle Dose

Middle dose, tablet, once daily, for six weeks

Intervention Type: DRUG

Experimental: OPC-34712 [Brexpiprazole] Low Dose

Lower dose, tablet, once daily, for six weeks

Intervention Type: DRUG

Placebo

Placebo, once daily, for six weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (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
• Major depressive 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

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandar Skuban, M.D.

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

Little Rock, Arkansas, United States

Garden Grove, California, United States

Glendale, California, United States

Oakland, California, United States

Oceanside, California, United States

San Diego, California, United States

San Diego, California, United States

Bradenton, Florida, United States

Miami Springs, Florida, United States

Orlando, Florida, United States

Fresh Meadows, New York, United States

Jamaica, New York, United States

Dayton, Ohio, United States

Charleston, South Carolina, United States

Charleston, South Carolina, United States

Austin, Texas, United States

Kirkland, Washington, United States

Burlington, Ontario, Canada

Chatham, Ontario, Canada

Chatham, Ontario, Canada

Fujisawa-shi, Kanagawa, Japan

Kunigami-gun, Okinawa, Japan

Sakai-shi, Osaka, Japan

Setagaya-ku, Tokyo-To, Japan

Kumamoto, , Japan

Daugavpils, , Latvia

Jelgava, , Latvia

Liepāja, , Latvia

Riga, , Latvia

Strenči, , Latvia

Choroszcz, , Poland

Gdansk, , Poland

Gdansk, , Poland

Lodz, , Poland

Arad, , Romania

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Focşani, , Romania

Piteşti, , Romania

Târgovişte, , Romania

Belgrade, , Serbia

Kragujevac, , Serbia

Novi Sad, , Serbia

Incheon, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Chernihiv, , Ukraine

Dnipropetrovsk, , Ukraine

Dnipropetrovsk, , Ukraine

Hlevakha, , Ukraine

Kherson, Vil. Stepanivka, , Ukraine

Kyiv, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Simferopol, , Ukraine

Vinnytsia, , Ukraine

Countries

United States; Canada; Japan; Latvia; Poland; Romania; Serbia; South Korea; Ukraine

References

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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

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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)

Correll CU, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, Eriksson H. Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial. Am J Psychiatry. 2015 Sep 1;172(9):870-80. doi: 10.1176/appi.ajp.2015.14101275. Epub 2015 Apr 16.

Reference Type: DERIVED

PMID: 25882325 (View on PubMed)

Other Identifiers

331-10-231

Identifier Type: -

Identifier Source: org_study_id