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

August 14, 2020 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
381

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
      • Kardzhali, Bulgaria, 6600
        • State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
      • Novi Iskar, Bulgaria, 1282
        • State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
      • Ruse, Bulgaria, 7003
        • "Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
      • Targovishte, Bulgaria, 7700
        • Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
      • Veliko Tarnovo, Bulgaria, 5000
        • Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
      • Vratsa, Bulgaria, 3000
        • Mental Health Center - Vratsa EOOD, Department of Psychiatry
  • Croatia
      • Rijeka, Croatia, 51000
        • CHC Rijeka-Clinic for Psychiatrics
      • Zagreb, Croatia, 10000
        • Poliklinika Neuron /Polyclinic Neuron
  • Poland
      • Gdańsk, Poland, 80-438
        • Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
      • Tuszyn, Poland, 95-080
        • NZOZ Prywatna Klinika Psychiatryczna Inventiva
  • Serbia
      • Belgrade, Serbia, 11000
        • CHC Dr Dragisa Misovic
      • Belgrade, Serbia, 11000
        • Clinic for Psychiatric Disorders, Dr Laza Lazarevic
      • Belgrade, Serbia, 11000
        • Clinic for Psychiatry
      • Kovin, Serbia, 26220
        • Specialized Hospital for Psychiatry Diseases Kovin
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac, Clinic of Psychiatry
      • Novi Sad, Serbia, 21000
        • Klinika za psihijariju, Klinicki Centar Vojvodine
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Regional Clinical Hospital n.a I.I. Mechnicov
      • Kharkiv, Ukraine, 61068
        • SI of Neurology Psychiatry and Narcology NAMS
      • Kherson, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
      • Kyiv, Ukraine, 04080
        • Kyiv Regional Medical Incorporation Psychiatry
      • Lviv, Ukraine, 79021
        • CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
      • Lviv, Ukraine, 79021
        • Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", Department #20
      • Odesa, Ukraine, 67513
        • Odesa Regional Psychiatric Hospital 2
      • Poltava, Ukraine, 36013
        • Maltsev Regional Clinical Psychiatric Hospital
      • Ternopil', Ukraine, 46027
        • Ternopil Regional Municipal Clinical Psychoneurological Hospital
      • Vinnitsa, Ukraine, 21018
        • O.I. Yushenko Vinnitsa Regional Clinic
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest, LLC
    • California
      • Bellflower, California, United States, 90706
        • Citrials Inc.
      • Cerritos, California, United States, 90703
        • Radiant Research
      • Culver City, California, United States, 90230
        • ProScience Research Group
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, LLC
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • Long Beach, California, United States, 90813
        • Apostle Clinical Trials
      • Oakland, California, United States, 94607
        • Pacific Research Partners, LLC
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Panorama City, California, United States, 91402
        • Asclepes Research Centers, PC
      • Riverside, California, United States, 92705
        • CI Trials
      • San Diego, California, United States, 92102
        • Cnri-San Diego
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Santa Ana, California, United States, 92705
        • CI Trials
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network, LLC
      • Yorba Linda, California, United States, 92886
        • Shreenath Clinical Service
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Optimus U Corp
      • Fort Lauderdale, Florida, United States, 33308
        • Segal Trials
      • Hialeah, Florida, United States, 33016
        • Galiz Research
      • Hollywood, Florida, United States, 33024
        • Research Centers of America, LLC
      • Largo, Florida, United States, 33770
        • Florida Behavioral Medicine
      • Tampa, Florida, United States, 33613
        • University of South Florida Board of Trustees
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Winfield, Illinois, United States, 60190
        • NeuroPsychiatric Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Louisiana Clinical Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates
      • Saint Louis, Missouri, United States, 63118
        • Arch Clinical Trials, LLC
      • Saint Louis, Missouri, United States, 63141
        • St. Louis Clinical Trials
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute, LLC
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Clinical Trials of America-NC, LLC
      • Raleigh, North Carolina, United States, 27609
        • Richard H Weisler, MD PA Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research Group
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research PLLC
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Fort Worth, Texas, United States, 76104
        • North Texas Clinical Trials
      • Garland, Texas, United States, 75042
        • Pillar Clinical Research LLC
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research, LLC
    • Washington
      • Everett, Washington, United States, 98201
        • Core Clinical Research
      • Richland, Washington, United States, 99352
        • Mid Columbia Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Brexpiprazole
Brexpiprazole tablets
Other Names:
  • OPC-34712

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity
Time Frame: 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.
From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 331-201-00083
  • 2017-002225-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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