Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

674

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2011

Typical duration for phase_3

Geographic Reach

8 countries

60 active sites

Status

completed

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

2.6 years study duration

Study Start

First participant enrolled

July 1, 2011

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

November 26, 2015

Completed

Last Updated

November 26, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

July 11, 2011

Results QC Date

August 11, 2015

Last Update Submit

October 26, 2015

Conditions

Acute Schizophrenia

Outcome Measures

Primary Outcomes (1)

Mean 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) and a score of 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 ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Baseline, Weeks 1, 2, 3, 4, 5, and 6

Secondary Outcomes (13)

Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.
Baseline, Week 3 and Week 6
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Week 6
+8 more secondary outcomes

Study Arms (4)

Dose 3 OPC 34712

EXPERIMENTAL

Higher dose, tablet, once daily, for six weeks

Drug: OPC-34712

Dose 2 OPC 34712

EXPERIMENTAL

Middle dose, tablet, once daily, for six weeks

Drug: OPC-34712

Dose 1 OPC 34712

EXPERIMENTAL

Lower dose, tablet, once daily, for six weeks

Drug: OPC-34712

Placebo

PLACEBO COMPARATOR

Placebo, once daily, for six weeks

Drug: Placebo

Interventions

OPC-34712DRUG

Higher dose tablet, once daily, for six weeks,

Dose 3 OPC 34712

PlaceboDRUG

Placebo, once daily, for six weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by 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
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

Otsuka Pharmaceutical Development & Commercialization, Inc.lead

Study Sites (60)

Unknown Facility

Little Rock, Arkansas, 72201, United States

Location

Unknown Facility

Springdale, Arkansas, 72764, United States

Location

Unknown Facility

Escondido, California, 92025, United States

Location

Unknown Facility

Long Beach, California, 90813, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Pico Rivera, California, 90660, United States

Location

Unknown Facility

San Diego, California, 92102, United States

Location

Unknown Facility

North Miami, Florida, 33161, United States

Location

Unknown Facility

North Miami, Florida, 33162, United States

Location

Unknown Facility

Overland Park, Kansas, 66212, United States

Location

Unknown Facility

Lake Charles, Louisiana, 70629, United States

Location

Unknown Facility

Shreveport, Louisiana, 71104, United States

Location

Unknown Facility

Flowood, Mississippi, 39232, United States

Location

Unknown Facility

St Louis, Missouri, 63118, United States

Location

Unknown Facility

Buffalo, New York, 14215, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Unknown Facility

Austin, Texas, 78756, United States

Location

Unknown Facility

Dallas, Texas, 75243, United States

Location

Unknown Facility

Houston, Texas, 77007, United States

Location

Unknown Facility

Bogotá, 00000, Colombia

Location

Unknown Facility

Medellín, 00000, Colombia

Location

Unknown Facility

Pereira, 00000, Colombia

Location

Unknown Facility

Rijeka, 51000, Croatia

Location

Unknown Facility

Zagreb, 10000, Croatia

Location

Unknown Facility

Zagreb, 10090, Croatia

Location

Unknown Facility

Col. Florida, Mexico City, 01030, Mexico

Location

Unknown Facility

Mexico City, Mexico City, 05300, Mexico

Location

Unknown Facility

Monterrey, Nuevo León, 64060, Mexico

Location

Unknown Facility

San Luis Potosí City, San Luis Potos, 78218, Mexico

Location

Unknown Facility

Monterrey, 64060, Mexico

Location

Unknown Facility

Cebu City, 6000, Philippines

Location

Unknown Facility

Davano City, 8000, Philippines

Location

Unknown Facility

Makati City, 1229, Philippines

Location

Unknown Facility

Mandaluyong, 1553, Philippines

Location

Unknown Facility

Manila, 1000, Philippines

Location

Unknown Facility

Arkhangelsk, 163530, Russia

Location

Unknown Facility

Moscow, 117152, Russia

Location

Unknown Facility

Moscow, 119991, Russia

Location

Unknown Facility

Moscow Region, 142601, Russia

Location

Unknown Facility

Nizhny Novgorod, 603155, Russia

Location

Unknown Facility

Petrozavodsk, 185000, Russia

Location

Unknown Facility

Saint Petersburg, 190005, Russia

Location

Unknown Facility

Saint Petersburg, 190121, Russia

Location

Unknown Facility

Saint Petersburg, 192019, Russia

Location

Unknown Facility

Saint Petersburg, 194214, Russia

Location

Unknown Facility

Saint Petersburg, 197341, Russia

Location

Unknown Facility

Samara, 443016, Russia

Location

Unknown Facility

Saratov, 410060, Russia

Location

Unknown Facility

Tomsk, 634014, Russia

Location

Unknown Facility

Village Nikolskoe, 188357, Russia

Location

Unknown Facility

Bojnice, 97201, Slovakia

Location

Unknown Facility

Bratislava, 82606, Slovakia

Location

Unknown Facility

Michalovace, 07101, Slovakia

Location

Unknown Facility

Rimavská Sobota, 97912, Slovakia

Location

Unknown Facility

Rožňava, 04801, Slovakia

Location

Unknown Facility

Kaohsiung City, 802, Taiwan

Location

Unknown Facility

New Taipei City, 249, Taiwan

Location

Unknown Facility

Taichung, 40447, Taiwan

Location

Unknown Facility

Taipei, 110, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

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: 40859756DERIVED
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.
PMID: 39749727DERIVED
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.
PMID: 35235720DERIVED
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.
PMID: 34901863DERIVED
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.
PMID: 29985680DERIVED
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.
PMID: 27188270DERIVED
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.
PMID: 25682550DERIVED

Results Point of Contact

Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

Study Officials

Aleksandar Skuban, M.D.
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

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 13, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 26, 2015

Results First Posted

November 26, 2015

Record last verified: 2015-10

Locations

ME(5)CR(3)US(19)SL(5)PH(5)RU(15)CO(3)TW(5)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (4)

Dose 3 OPC 34712

Dose 2 OPC 34712

Dose 1 OPC 34712

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (60)

Related Publications (7)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations