A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
NCT ID: NCT03287869
Last Updated: 2020-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2017-10-24
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Brexpiprazole
Brexpiprazole 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.
Brexpiprazole
Brexpiprazole tablets
Interventions
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Brexpiprazole
Brexpiprazole tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
Citrials Inc.
Bellflower, California, United States
Radiant Research
Cerritos, California, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Apostle Clinical Trials
Long Beach, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
NRC Research Institute
Orange, California, United States
Asclepes Research Centers, PC
Panorama City, California, United States
CI Trials
Riverside, California, United States
CNRI-San Diego
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
CI Trials
Santa Ana, California, United States
Collaborative Neuroscience Network, LLC
Torrance, California, United States
Shreenath Clinical Service
Yorba Linda, California, United States
Optimus U Corp
Coral Gables, Florida, United States
Segal Trials
Fort Lauderdale, Florida, United States
Galiz Research
Hialeah, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Florida Behavioral Medicine
Largo, Florida, United States
University of South Florida Board of Trustees
Tampa, Florida, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
NeuroPsychiatric Research
Winfield, Illinois, United States
Louisiana Clinical Research
Shreveport, Louisiana, United States
CBH Health
Gaithersburg, Maryland, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
Arch Clinical Trials, LLC
St Louis, Missouri, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Hassman Research Institute, LLC
Berlin, New Jersey, United States
Clinical Trials of America-NC, LLC
Hickory, North Carolina, United States
Richard H Weisler, MD PA Associates
Raleigh, North Carolina, United States
SP Research PLLC
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Community Clinical Research, Inc.
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
Pillar Clinical Research LLC
Garland, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Core Clinical Research
Everett, Washington, United States
Mid Columbia Research
Richland, Washington, United States
Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
Burgas, , Bulgaria
State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
Kardzhali, , Bulgaria
State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
Novi Iskar, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
Plovdiv, , Bulgaria
"Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
Rousse, , Bulgaria
University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
Targovishte, , Bulgaria
Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
Veliko Tarnovo, , Bulgaria
Mental Health Center - Vratsa EOOD, Department of Psychiatry
Vratsa, , Bulgaria
CHC Rijeka-Clinic for Psychiatrics
Rijeka, , Croatia
Poliklinika Neuron /Polyclinic Neuron
Zagreb, , Croatia
Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
Gdansk, , Poland
NZOZ Prywatna Klinika Psychiatryczna Inventiva
Tuszyn, , Poland
CHC Dr Dragisa Misovic
Belgrade, , Serbia
Clinic for Psychiatric Disorders, Dr Laza Lazarevic
Belgrade, , Serbia
Clinic for Psychiatry
Belgrade, , Serbia
Specialized Hospital for Psychiatry Diseases Kovin
Kovin, , Serbia
Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac, , Serbia
Klinika za psihijariju, Klinicki Centar Vojvodine
Novi Sad, , Serbia
Regional Clinical Hospital n.a I.I. Mechnicov
Dnipro, , Ukraine
SI of Neurology Psychiatry and Narcology NAMS
Kharkiv, , Ukraine
Kherson Regional Psychiatric Hospital
Kherson, , Ukraine
Kyiv Regional Medical Incorporation Psychiatry
Kyiv, , Ukraine
CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
Lviv, , Ukraine
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
Lviv, , Ukraine
Odesa Regional Psychiatric Hospital 2
Odesa, , Ukraine
Maltsev Regional Clinical Psychiatric Hospital
Poltava, , Ukraine
Ternopil Regional Municipal Clinical Psychoneurological Hospital
Ternopil, , Ukraine
O.I. Yushenko Vinnitsa Regional Clinic
Vinnitsa, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002225-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
331-201-00083
Identifier Type: -
Identifier Source: org_study_id
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