A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
- Registration Number
- NCT03287869
- 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.
- Detailed Description
While the availability of atypical antipsychotics had increased the therapeutic options available, there remains a need for safer and more effective therapies in the treatment of manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor activity profile likely correlates with its established efficacy in schizophrenia and major depressive disorder, and may prove to be an effective target for the treatment of acute mania of bipolar I disorder.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 381
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brexpiprazole 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.
- Primary Outcome Measures
Name Time Method Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Woodland Research Northwest, LLC
πΊπΈRogers, Arkansas, United States
"Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
π§π¬Ruse, Bulgaria
Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
π΅π±GdaΕsk, Poland
Clinic for Psychiatric Disorders, Dr Laza Lazarevic
π·πΈBelgrade, Serbia
Regional Clinical Hospital n.a I.I. Mechnicov
πΊπ¦Dnipro, Ukraine
Mental Health Center - Vratsa EOOD, Department of Psychiatry
π§π¬Vratsa, Bulgaria
Clinical Center Kragujevac, Clinic of Psychiatry
π·πΈKragujevac, Serbia
Odesa Regional Psychiatric Hospital 2
πΊπ¦Odesa, Ukraine
Kherson Regional Psychiatric Hospital
πΊπ¦Kherson, Ukraine
Kyiv Regional Medical Incorporation Psychiatry
πΊπ¦Kyiv, Ukraine
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
πΊπ¦Lviv, Ukraine
Ternopil Regional Municipal Clinical Psychoneurological Hospital
πΊπ¦Ternopil', Ukraine
Collaborative Neuroscience Network, LLC
πΊπΈTorrance, California, United States
NeuroPsychiatric Research
πΊπΈWinfield, Illinois, United States
Segal Trials
πΊπΈFort Lauderdale, Florida, United States
Pacific Research Partners, LLC
πΊπΈOakland, California, United States
Behavioral Research Specialists, LLC
πΊπΈGlendale, California, United States
Shreenath Clinical Service
πΊπΈYorba Linda, California, United States
St. Charles Psychiatric Associates
πΊπΈSaint Charles, Missouri, United States
Citrials Inc.
πΊπΈBellflower, California, United States
ProScience Research Group
πΊπΈCulver City, California, United States
State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
π§π¬Novi Iskar, Bulgaria
Hassman Research Institute, LLC
πΊπΈBerlin, New Jersey, United States
Alexian Brothers Center for Psychiatric Research
πΊπΈHoffman Estates, Illinois, United States
Pillar Clinical Research, LLC
πΊπΈRichardson, Texas, United States
CBH Health
πΊπΈGaithersburg, Maryland, United States
University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
π§π¬Sofia, Bulgaria
Louisiana Clinical Research
πΊπΈShreveport, Louisiana, United States
Mid Columbia Research
πΊπΈRichland, Washington, United States
St. Louis Clinical Trials
πΊπΈSaint Louis, Missouri, United States
State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
π§π¬Kardzhali, Bulgaria
Clinic for Psychiatry
π·πΈBelgrade, Serbia
North Texas Clinical Trials
πΊπΈFort Worth, Texas, United States
Poliklinika Neuron /Polyclinic Neuron
ππ·Zagreb, Croatia
NZOZ Prywatna Klinika Psychiatryczna Inventiva
π΅π±Tuszyn, Poland
SI of Neurology Psychiatry and Narcology NAMS
πΊπ¦Kharkiv, Ukraine
Maltsev Regional Clinical Psychiatric Hospital
πΊπ¦Poltava, Ukraine
O.I. Yushenko Vinnitsa Regional Clinic
πΊπ¦Vinnitsa, Ukraine
Pillar Clinical Research LLC
πΊπΈGarland, Texas, United States
CHC Rijeka-Clinic for Psychiatrics
ππ·Rijeka, Croatia
CHC Dr Dragisa Misovic
π·πΈBelgrade, Serbia
Artemis Institute for Clinical Research
πΊπΈSan Diego, California, United States
Sharp Mesa Vista Hospital
πΊπΈSan Diego, California, United States
SP Research PLLC
πΊπΈOklahoma City, Oklahoma, United States
iResearch Atlanta, LLC
πΊπΈDecatur, Georgia, United States
Galiz Research
πΊπΈHialeah, Florida, United States
Research Centers of America, LLC
πΊπΈHollywood, Florida, United States
Florida Behavioral Medicine
πΊπΈLargo, Florida, United States
Woodland International Research Group
πΊπΈLittle Rock, Arkansas, United States
Apostle Clinical Trials
πΊπΈLong Beach, California, United States
Asclepes Research Centers, PC
πΊπΈPanorama City, California, United States
NRC Research Institute
πΊπΈOrange, California, United States
CI Trials
πΊπΈSanta Ana, California, United States
CNRI-San Diego
πΊπΈSan Diego, California, United States
Optimus U Corp
πΊπΈCoral Gables, Florida, United States
Arch Clinical Trials, LLC
πΊπΈSaint Louis, Missouri, United States
Clinical Trials of America-NC, LLC
πΊπΈHickory, North Carolina, United States
Richard H Weisler, MD PA Associates
πΊπΈRaleigh, North Carolina, United States
Cutting Edge Research Group
πΊπΈOklahoma City, Oklahoma, United States
InSite Clinical Research
πΊπΈDeSoto, Texas, United States
Core Clinical Research
πΊπΈEverett, Washington, United States
Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
π§π¬Burgas, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
π§π¬Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
π§π¬Targovishte, Bulgaria
Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
π§π¬Veliko Tarnovo, Bulgaria
Specialized Hospital for Psychiatry Diseases Kovin
π·πΈKovin, Serbia
Klinika za psihijariju, Klinicki Centar Vojvodine
π·πΈNovi Sad, Serbia
CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
πΊπ¦Lviv, Ukraine
University of South Florida Board of Trustees
πΊπΈTampa, Florida, United States
Community Clinical Research, Inc.
πΊπΈAustin, Texas, United States
Radiant Research
πΊπΈCerritos, California, United States