Clinical trial NCT03287869: A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Official title: A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Acute Mania
Keywords: Bipolar
Mania
Brexpiprazole
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2017-09-19
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Intervention model description: Group composed of eligible rollover participants who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 (NCT03259555) or 331-201-00081 (NCT03257865)).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria (rollover participants from 331-201-00080 \& 331-201-00081 trials)

* 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 Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.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.

Exclusion Criteria (rollover participants from 331-201-00080 \& 331-201-00081 trials)

* 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).

Primary outcomes:
measure: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity
timeFrame: From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Bellflower
country: United States
facility: Citrials Inc.
state: California
city: Cerritos
country: United States
facility: Radiant Research
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Long Beach
country: United States
facility: Apostle Clinical Trials
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers, PC
state: California
city: Riverside
country: United States
facility: CI Trials
state: California
city: San Diego
country: United States
facility: CNRI-San Diego
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Santa Ana
country: United States
facility: CI Trials
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Yorba Linda
country: United States
facility: Shreenath Clinical Service
state: California
city: Coral Gables
country: United States
facility: Optimus U Corp
state: Florida
city: Fort Lauderdale
country: United States
facility: Segal Trials
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Largo
country: United States
facility: Florida Behavioral Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida Board of Trustees
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Winfield
country: United States
facility: NeuroPsychiatric Research
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: Saint Louis
country: United States
facility: Arch Clinical Trials, LLC
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
city: Hickory
country: United States
facility: Clinical Trials of America-NC, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Richard H Weisler, MD PA Associates
state: North Carolina
city: Oklahoma City
country: United States
facility: SP Research PLLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Garland
country: United States
facility: Pillar Clinical Research LLC
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
city: Richland
country: United States
facility: Mid Columbia Research
state: Washington
city: Burgas
country: Bulgaria
facility: Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
city: Kardzhali
country: Bulgaria
facility: State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
city: Novi Iskar
country: Bulgaria
facility: State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
city: Ruse
country: Bulgaria
facility: "Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
city: Targovishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
city: Veliko Tarnovo
country: Bulgaria
facility: Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
city: Vratsa
country: Bulgaria
facility: Mental Health Center - Vratsa EOOD, Department of Psychiatry
city: Rijeka
country: Croatia
facility: CHC Rijeka-Clinic for Psychiatrics
city: Zagreb
country: Croatia
facility: Poliklinika Neuron /Polyclinic Neuron
city: Gdańsk
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
city: Tuszyn
country: Poland
facility: NZOZ Prywatna Klinika Psychiatryczna Inventiva
city: Belgrade
country: Serbia
facility: CHC Dr Dragisa Misovic
city: Belgrade
country: Serbia
facility: Clinic for Psychiatric Disorders, Dr Laza Lazarevic
city: Belgrade
country: Serbia
facility: Clinic for Psychiatry
city: Kovin
country: Serbia
facility: Specialized Hospital for Psychiatry Diseases Kovin
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic of Psychiatry
city: Novi Sad
country: Serbia
facility: Klinika za psihijariju, Klinicki Centar Vojvodine
city: Dnipro
country: Ukraine
facility: Regional Clinical Hospital n.a I.I. Mechnicov
city: Kharkiv
country: Ukraine
facility: SI of Neurology Psychiatry and Narcology NAMS
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
city: Kyiv
country: Ukraine
facility: Kyiv Regional Medical Incorporation Psychiatry
city: Lviv
country: Ukraine
facility: CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
city: Lviv
country: Ukraine
facility: Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
city: Odesa
country: Ukraine
facility: Odesa Regional Psychiatric Hospital 2
city: Poltava
country: Ukraine
facility: Maltsev Regional Clinical Psychiatric Hospital
city: Ternopil'
country: Ukraine
facility: Ternopil Regional Municipal Clinical Psychoneurological Hospital
city: Vinnitsa
country: Ukraine
facility: O.I. Yushenko Vinnitsa Regional Clinic
Study officials:
References: