Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
210 participants
INTERVENTIONAL
2013-07-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Brexpiprazole in Patients With Acute Schizophrenia
NCT01810380
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
NCT03198078
Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia
NCT02968121
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
NCT02013622
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
NCT02054702
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Brexpiprazole
Brexpiprazole
1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brexpiprazole
1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
* The patient agrees to protocol-defined use of effective contraception.
Exclusion Criteria
* The patient has a clinically significant unstable illness diagnosed during Study 14644A.
* The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
H. Lundbeck A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
US010
Anaheim, California, United States
US020
Cerritos, California, United States
US009
Escondido, California, United States
US022
Garden Grove, California, United States
US018
Long Beach, California, United States
US011
San Diego, California, United States
US021
Washington D.C., District of Columbia, United States
US004
Kissimmee, Florida, United States
US015
North Miami, Florida, United States
US019
Lake Charles, Louisiana, United States
US016
St Louis, Missouri, United States
US002
Cedarhurst, New York, United States
US005
Charleston, South Carolina, United States
US003
Austin, Texas, United States
US012
Austin, Texas, United States
US001
Dallas, Texas, United States
US013
Dallas, Texas, United States
EE002
Pärnu, , Estonia
EE001
Tallinn, , Estonia
PL002
Choroszcz, , Poland
PL005
Choroszcz, , Poland
PL004
Gdansk, , Poland
RO004
Brasov, , Romania
RO007
Bucharest, , Romania
RO011
Bucharest, , Romania
RO012
Bucharest, , Romania
RO010
Iași, , Romania
RO006
Piteşti, , Romania
RU001
Arkhangelsk, , Russia
RU008
Moscow, , Russia
RU015
Rostov-on-Don, , Russia
RU004
Saint Petersburg, , Russia
RU005
Saint Petersburg, , Russia
RU013
Saint Petersburg, , Russia
RU002
Saratov, , Russia
RS001
Belgrade, , Serbia
RS003
Belgrade, , Serbia
RS002
Kragujevac, , Serbia
RS004
Novi Kneževac, , Serbia
SK001
Liptovský Mikuláš, , Slovakia
UA012
Dnipropetrovsk, , Ukraine
UA004
Geikivka, , Ukraine
UA007
Hlevakha, , Ukraine
UA005
Kherson, , Ukraine
UA008
Kyiv, , Ukraine
UA009
Lviv, , Ukraine
UA002
Smila, , Ukraine
UA003
Vinnytsia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-002705-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14644B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.