Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
VECTOR
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
1 other identifier
interventional
636
9 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Typical duration for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
October 29, 2015
CompletedOctober 29, 2015
September 1, 2015
2.5 years
July 11, 2011
August 4, 2015
September 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Baseline to Week 6
Secondary Outcomes (15)
Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Baseline to Week 6
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.
Baseline to Week 1, 2, 3, 4, 5
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Baseline to Week 1, 2, 3, 4 and 5
Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
Baseline to Week 6
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score
Baseline to Week 6
- +10 more secondary outcomes
Study Arms (4)
OPC-34712 [Brexpiprazole] High Dose
EXPERIMENTALHigher Dose, tablet, once daily, for six weeks
OPC-34712 [Brexpiprazole] Middle Dose
EXPERIMENTALMiddle Dose, tablet, once daily, for six weeks
OPC-34712 [Brexpiprazole] Low Dose
EXPERIMENTALLower Dose, tablet, once daily, for six weeks
Placebo
PLACEBO COMPARATORPlacebo, once daily, for six weeks
Interventions
Higher dose, tablet, once daily, for six weeks
Middle dose, tablet, once daily, for six weeks
Lower dose, tablet, once daily, for six weeks
Eligibility Criteria
You may qualify if:
- 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
- Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
- Subjects experiencing an acute exacerbation of psychotic symptoms
You may not qualify if:
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
- 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
- Subjects presenting with a first episode of schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
Oakland, California, 94612, United States
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Oceanside, California, 92056, United States
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San Diego, California, 92102, United States
Unknown Facility
San Diego, California, 92123, United States
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Bradenton, Florida, 34208, United States
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Miami Springs, Florida, 33166, United States
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Orlando, Florida, 32806, United States
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Fresh Meadows, New York, 11423, United States
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Jamaica, New York, 11432, United States
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Dayton, Ohio, 45417, United States
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Charleston, South Carolina, 29405, United States
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Charleston, South Carolina, 29407, United States
Unknown Facility
Austin, Texas, 78754, United States
Unknown Facility
Kirkland, Washington, 98033, United States
Unknown Facility
Burlington, Ontario, L7R 4E2, Canada
Unknown Facility
Chatham, Ontario, N7L 1B7, Canada
Unknown Facility
Chatham, Ontario, N7M 5L9, Canada
Unknown Facility
Fujisawa-shi, Kanagawa, 251-8530, Japan
Unknown Facility
Kunigami-gun, Okinawa, 904-1201, Japan
Unknown Facility
Sakai-shi, Osaka, 590-0018, Japan
Unknown Facility
Setagaya-ku, Tokyo-To, 156-0057, Japan
Unknown Facility
Kumamoto, 861-8002, Japan
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Daugavpils, LV-5417, Latvia
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Jelgava, LV-3008, Latvia
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Liepāja, LV-3401, Latvia
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Riga, LV-1005, Latvia
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Strenči, LV-4730, Latvia
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Choroszcz, 16-070, Poland
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Gdansk, 80-282, Poland
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Gdansk, 80-952, Poland
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Lodz, 91-229, Poland
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Arad, 310022, Romania
Unknown Facility
Bucharest, 010825, Romania
Unknown Facility
Bucharest, 030442, Romania
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Bucharest, 041914, Romania
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Cluj-Napoca, 400012, Romania
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Focşani, 620165, Romania
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Piteşti, 110069, Romania
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Târgovişte, 130086, Romania
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Novi Sad, 21000, Serbia
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Incheon, 400-711, South Korea
Unknown Facility
Incheon, 405-760, South Korea
Unknown Facility
Seoul, 136-705, South Korea
Unknown Facility
Seoul, 137-710, South Korea
Unknown Facility
Seoul, 143-711, South Korea
Unknown Facility
Chernihiv, 14000, Ukraine
Unknown Facility
Dnipropetrovsk, 49005, Ukraine
Unknown Facility
Dnipropetrovsk, 49115, Ukraine
Unknown Facility
Hlevakha, 08631, Ukraine
Unknown Facility
Kherson, Vil. Stepanivka, 73488, Ukraine
Unknown Facility
Kyiv, 02660, Ukraine
Unknown Facility
Kyiv, 04080, Ukraine
Unknown Facility
Lviv, 79021, Ukraine
Unknown Facility
Simferopol, 95006, Ukraine
Unknown Facility
Vinnytsia, 21005, Ukraine
Related Publications (7)
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 Aug;41(8):1535-1548. doi: 10.1080/03007995.2025.2552286. Epub 2025 Sep 11.
PMID: 40859756DERIVEDIsmail 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.
PMID: 39749727DERIVEDCorrell 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.
PMID: 35235720DERIVEDMarder 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.
PMID: 34901863DERIVEDNewcomer 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.
PMID: 29985680DERIVEDKane 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.
PMID: 27188270DERIVEDCorrell 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.
PMID: 25882325DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Global Medical Affairs
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc
Study Officials
- STUDY DIRECTOR
Aleksandar Skuban, M.D.
Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 18, 2011
Study Start
July 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
October 29, 2015
Results First Posted
October 29, 2015
Record last verified: 2015-09