A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
2 other identifiers
interventional
381
6 countries
73
Brief Summary
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2017
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedResults Posted
Study results publicly available
August 17, 2020
CompletedAugust 17, 2020
August 1, 2020
1.8 years
August 24, 2017
July 29, 2020
August 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs severity were graded on a 3-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, and 3 = severe; inability to work or perform normal daily activity.
From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)
Study Arms (1)
Brexpiprazole
EXPERIMENTALBrexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4.
Interventions
Eligibility Criteria
You may qualify if:
- Participants remaining in hospital at the Day 21 visit of trial 331-201-00080 or 331-201-00081 were permitted to enroll in the 331-201-00083 trial at the week 3 visit of the double-blind trial if they were planned to be discharged from the hospital before the week 1 visit of trial 331-201-0083. Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.
- Participants who, in the opinion of the investigator, could potentially benefit from administration of oral brexpiprazole for the treatment of bipolar I disorder and who completed 3 weeks of post-randomization treatment in Trial 331-201-00080 \& Trial 331-201-00081.
You may not qualify if:
- Participants with a major protocol violation during the course of their participation in the double-blind phase 3 trials (331-201-00080 or 331-201-00081).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758, United States
Citrials Inc.
Bellflower, California, 90706, United States
Radiant Research
Cerritos, California, 90703, United States
ProScience Research Group
Culver City, California, 90230, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Apostle Clinical Trials
Long Beach, California, 90813, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
NRC Research Institute
Orange, California, 92868, United States
Asclepes Research Centers, PC
Panorama City, California, 91402, United States
CI Trials
Riverside, California, 92705, United States
CNRI-San Diego
San Diego, California, 92102, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
CI Trials
Santa Ana, California, 92705, United States
Collaborative Neuroscience Network, LLC
Torrance, California, 90502, United States
Shreenath Clinical Service
Yorba Linda, California, 92886, United States
Optimus U Corp
Coral Gables, Florida, 33134, United States
Segal Trials
Fort Lauderdale, Florida, 33308, United States
Galiz Research
Hialeah, Florida, 33016, United States
Research Centers of America, LLC
Hollywood, Florida, 33024, United States
Florida Behavioral Medicine
Largo, Florida, 33770, United States
University of South Florida Board of Trustees
Tampa, Florida, 33613, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
NeuroPsychiatric Research
Winfield, Illinois, 60190, United States
Louisiana Clinical Research
Shreveport, Louisiana, 71101, United States
CBH Health
Gaithersburg, Maryland, 20877, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304, United States
Arch Clinical Trials, LLC
St Louis, Missouri, 63118, United States
St. Louis Clinical Trials
St Louis, Missouri, 63141, United States
Hassman Research Institute, LLC
Berlin, New Jersey, 08009, United States
Clinical Trials of America-NC, LLC
Hickory, North Carolina, 28601, United States
Richard H Weisler, MD PA Associates
Raleigh, North Carolina, 27609, United States
SP Research PLLC
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Pillar Clinical Research LLC
Garland, Texas, 75042, United States
Pillar Clinical Research, LLC
Richardson, Texas, 75080, United States
Core Clinical Research
Everett, Washington, 98201, United States
Mid Columbia Research
Richland, Washington, 99352, United States
Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
Burgas, 8000, Bulgaria
State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
Kardzhali, 6600, Bulgaria
State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
Novi Iskar, 1282, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
Plovdiv, 4002, Bulgaria
"Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
Rousse, 7003, Bulgaria
University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
Sofia, 1431, Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
Targovishte, 7700, Bulgaria
Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
Veliko Tarnovo, 5000, Bulgaria
Mental Health Center - Vratsa EOOD, Department of Psychiatry
Vratsa, 3000, Bulgaria
CHC Rijeka-Clinic for Psychiatrics
Rijeka, 51000, Croatia
Poliklinika Neuron /Polyclinic Neuron
Zagreb, 10000, Croatia
Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
Gdansk, 80-438, Poland
NZOZ Prywatna Klinika Psychiatryczna Inventiva
Tuszyn, 95-080, Poland
CHC Dr Dragisa Misovic
Belgrade, 11000, Serbia
Clinic for Psychiatric Disorders, Dr Laza Lazarevic
Belgrade, 11000, Serbia
Clinic for Psychiatry
Belgrade, 11000, Serbia
Specialized Hospital for Psychiatry Diseases Kovin
Kovin, 26220, Serbia
Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac, 34000, Serbia
Klinika za psihijariju, Klinicki Centar Vojvodine
Novi Sad, 21000, Serbia
Regional Clinical Hospital n.a I.I. Mechnicov
Dnipro, 49005, Ukraine
SI of Neurology Psychiatry and Narcology NAMS
Kharkiv, 61068, Ukraine
Kherson Regional Psychiatric Hospital
Kherson, 73488, Ukraine
Kyiv Regional Medical Incorporation Psychiatry
Kyiv, 04080, Ukraine
CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
Lviv, 79021, Ukraine
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
Lviv, 79021, Ukraine
Odesa Regional Psychiatric Hospital 2
Odesa, 67513, Ukraine
Maltsev Regional Clinical Psychiatric Hospital
Poltava, 36013, Ukraine
Ternopil Regional Municipal Clinical Psychoneurological Hospital
Ternopil, 46027, Ukraine
O.I. Yushenko Vinnitsa Regional Clinic
Vinnitsa, 21018, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
As predefined in the protocol, there were no primary or secondary efficacy endpoints in this trial.
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2017
First Posted
September 19, 2017
Study Start
October 24, 2017
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
August 17, 2020
Results First Posted
August 17, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.