Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
NCT ID: NCT02013622
Last Updated: 2016-03-29
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
49 participants
INTERVENTIONAL
2013-11-30
2014-10-31
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 (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
NCT02054702
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
NCT03198078
Brexpiprazole in Patients With Acute Schizophrenia
NCT01810380
Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia
NCT02968121
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
NCT05325645
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
Up to 4 mg/day, once daily dose, tablets, orally
Brexpiprazole
Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brexpiprazole
Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
* Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.
* Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.
* Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.
Exclusion Criteria
* Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
* Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
* Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
* Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of\>= 3 on Item 8 of the AIMS at screening or baseline.
* Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
* Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.
18 Years
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Junichi Hashimoto, PhD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cerritos, California, United States
Chula Vista, California, United States
Costa Mesa, California, United States
Long Beach, California, United States
Oakland, California, United States
Oceanside, California, United States
Pico Rivera, California, United States
Riverside, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Torrance, California, United States
Fort Lauderdale, Florida, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Lake Charles, Louisiana, United States
Rochester, New York, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
331-13-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.