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A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

Primary Purpose

Bipolar I Disorder, Acute Mania

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder focused on measuring Bipolar, Mania, Brexpiprazole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.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

Sites / Locations

  • Woodland International Research Group
  • Woodland Research Northwest, LLC
  • Citrials Inc.
  • Radiant Research
  • ProScience Research Group
  • Collaborative Neuroscience Network, LLC
  • Behavioral Research Specialists, LLC
  • Apostle Clinical Trials
  • Pacific Research Partners, LLC
  • NRC Research Institute
  • Asclepes Research Centers, PC
  • CI Trials
  • CNRI-San Diego
  • Artemis Institute for Clinical Research
  • Sharp Mesa Vista Hospital
  • CI Trials
  • Collaborative Neuroscience Network, LLC
  • Shreenath Clinical Service
  • Optimus U Corp
  • Segal Trials
  • Galiz Research
  • Research Centers of America, LLC
  • Florida Behavioral Medicine
  • University of South Florida Board of Trustees
  • iResearch Atlanta, LLC
  • Alexian Brothers Center for Psychiatric Research
  • NeuroPsychiatric Research
  • Louisiana Clinical Research
  • CBH Health
  • St. Charles Psychiatric Associates
  • Arch Clinical Trials, LLC
  • St. Louis Clinical Trials
  • Hassman Research Institute, LLC
  • Clinical Trials of America-NC, LLC
  • Richard H Weisler, MD PA Associates
  • SP Research PLLC
  • Cutting Edge Research Group
  • Community Clinical Research, Inc.
  • InSite Clinical Research
  • North Texas Clinical Trials
  • Pillar Clinical Research LLC
  • Pillar Clinical Research, LLC
  • Core Clinical Research
  • Mid Columbia Research
  • Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
  • State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
  • State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
  • "Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
  • University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
  • Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
  • Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
  • Mental Health Center - Vratsa EOOD, Department of Psychiatry
  • CHC Rijeka-Clinic for Psychiatrics
  • Poliklinika Neuron /Polyclinic Neuron
  • Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
  • NZOZ Prywatna Klinika Psychiatryczna Inventiva
  • CHC Dr Dragisa Misovic
  • Clinic for Psychiatric Disorders, Dr Laza Lazarevic
  • Clinic for Psychiatry
  • Specialized Hospital for Psychiatry Diseases Kovin
  • Clinical Center Kragujevac, Clinic of Psychiatry
  • Klinika za psihijariju, Klinicki Centar Vojvodine
  • Regional Clinical Hospital n.a I.I. Mechnicov
  • SI of Neurology Psychiatry and Narcology NAMS
  • Kherson Regional Psychiatric Hospital
  • Kyiv Regional Medical Incorporation Psychiatry
  • CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
  • Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
  • Odesa Regional Psychiatric Hospital 2
  • Maltsev Regional Clinical Psychiatric Hospital
  • Ternopil Regional Municipal Clinical Psychoneurological Hospital
  • O.I. Yushenko Vinnitsa Regional Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brexpiprazole

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2017
Last Updated
August 14, 2020
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03287869
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder, Acute Mania
Keywords
Bipolar, Mania, Brexpiprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)).
Masking
None (Open Label)
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brexpiprazole
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Other Intervention Name(s)
OPC-34712
Intervention Description
Brexpiprazole tablets
Primary Outcome Measure Information:
Title
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity
Description
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.
Time Frame
From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Citrials Inc.
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Radiant Research
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Apostle Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Asclepes Research Centers, PC
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
CI Trials
City
Riverside
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
CNRI-San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
CI Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Shreenath Clinical Service
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
Optimus U Corp
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Segal Trials
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Research Centers of America, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Florida Behavioral Medicine
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
University of South Florida Board of Trustees
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
NeuroPsychiatric Research
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Louisiana Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
St. Charles Psychiatric Associates
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
St. Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hassman Research Institute, LLC
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Trials of America-NC, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Richard H Weisler, MD PA Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
SP Research PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Pillar Clinical Research LLC
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Mid Columbia Research
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
"Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Mental Health Center - Vratsa EOOD, Department of Psychiatry
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
CHC Rijeka-Clinic for Psychiatrics
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Poliklinika Neuron /Polyclinic Neuron
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
City
Gdańsk
ZIP/Postal Code
80-438
Country
Poland
Facility Name
NZOZ Prywatna Klinika Psychiatryczna Inventiva
City
Tuszyn
ZIP/Postal Code
95-080
Country
Poland
Facility Name
CHC Dr Dragisa Misovic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Psychiatric Disorders, Dr Laza Lazarevic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Specialized Hospital for Psychiatry Diseases Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic of Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Klinika za psihijariju, Klinicki Centar Vojvodine
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Regional Clinical Hospital n.a I.I. Mechnicov
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
SI of Neurology Psychiatry and Narcology NAMS
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Kyiv Regional Medical Incorporation Psychiatry
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Odesa Regional Psychiatric Hospital 2
City
Odesa
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Maltsev Regional Clinical Psychiatric Hospital
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Facility Name
Ternopil Regional Municipal Clinical Psychoneurological Hospital
City
Ternopil'
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
O.I. Yushenko Vinnitsa Regional Clinic
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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
IPD Sharing URL
https://clinical-trials.otsuka.com

Learn more about this trial

A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

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