AzTrials
AzTrials

Bipolar I DisorderPhase 3NCT03287869

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

A Phase 3 study testing Brexpiprazole in people with Bipolar I Disorder and Acute Mania, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar I Disorder, Acute Mania
What is being tested?
Brexpiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
381 participants
Where
73 sitesin 6 countries
Study dates
24 Oct 2017to 31 Jul 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.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

Trial locations and contacts

73 sites in 6 countries.

73 sites in 6 countries

United States44 sites

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • Citrials Inc.

    Bellflower, California, 90706

  • Hassman Research Institute, LLC

    Berlin, New Jersey, 08009

  • Radiant Research

    Cerritos, California, 90703

  • Optimus U Corp

    Coral Gables, Florida, 33134

  • ProScience Research Group

    Culver City, California, 90230

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Core Clinical Research

    Everett, Washington, 98201

  • Segal Trials

    Fort Lauderdale, Florida, 33308

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • CBH Health

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Pillar Clinical Research LLC

    Garland, Texas, 75042

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • Galiz Research

    Hialeah, Florida, 33016

  • Clinical Trials of America-NC, LLC

    Hickory, North Carolina, 28601

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois, 60169

  • Research Centers of America, LLC

    Hollywood, Florida, 33024

  • Florida Behavioral Medicine

    Largo, Florida, 33770

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Apostle Clinical Trials

    Long Beach, California, 90813

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • SP Research PLLC

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • NRC Research Institute

    Orange, California, 92868

  • Asclepes Research Centers, PC

    Panorama City, California, 91402

  • Richard H Weisler, MD PA Associates

    Raleigh, North Carolina, 27609

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • Mid Columbia Research

    Richland, Washington, 99352

  • CI Trials

    Riverside, California, 92705

  • Woodland Research Northwest, LLC

    Rogers, Arkansas, 72758

  • St. Charles Psychiatric Associates

    Saint Charles, Missouri, 63304

  • CNRI-San Diego

    San Diego, California, 92102

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • CI Trials

    Santa Ana, California, 92705

  • Louisiana Clinical Research

    Shreveport, Louisiana, 71101

  • Arch Clinical Trials, LLC

    St Louis, Missouri, 63118

  • St. Louis Clinical Trials

    St Louis, Missouri, 63141

  • University of South Florida Board of Trustees

    Tampa, Florida, 33613

  • Collaborative Neuroscience Network, LLC

    Torrance, California, 90502

  • NeuroPsychiatric Research

    Winfield, Illinois, 60190

  • Shreenath Clinical Service

    Yorba Linda, California, 92886

Other trials in United States

Ukraine10 sites

  • Regional Clinical Hospital n.a I.I. Mechnicov

    Dnipro, 49005

  • SI of Neurology Psychiatry and Narcology NAMS

    Kharkiv, 61068

  • Kherson Regional Psychiatric Hospital

    Kherson, 73488

  • Kyiv Regional Medical Incorporation Psychiatry

    Kyiv, 04080

  • CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25

    Lviv, 79021

  • Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20

    Lviv, 79021

  • Odesa Regional Psychiatric Hospital 2

    Odesa, 67513

  • Maltsev Regional Clinical Psychiatric Hospital

    Poltava, 36013

  • Ternopil Regional Municipal Clinical Psychoneurological Hospital

    Ternopil, 46027

  • O.I. Yushenko Vinnitsa Regional Clinic

    Vinnitsa, 21018

Other trials in Ukraine

Bulgaria9 sites

  • Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition

    Burgas, 8000

  • State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department

    Kardzhali, 6600

  • State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department

    Novi Iskar, 1282

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry

    Plovdiv, 4002

  • "Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders

    Rousse, 7003

  • University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry

    Sofia, 1431

  • Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry

    Targovishte, 7700

  • Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders

    Veliko Tarnovo, 5000

  • Mental Health Center - Vratsa EOOD, Department of Psychiatry

    Vratsa, 3000

Other trials in Bulgaria

Serbia6 sites

  • CHC Dr Dragisa Misovic

    Belgrade, 11000

  • Clinic for Psychiatric Disorders, Dr Laza Lazarevic

    Belgrade, 11000

  • Clinic for Psychiatry

    Belgrade, 11000

  • Specialized Hospital for Psychiatry Diseases Kovin

    Kovin, 26220

  • Clinical Center Kragujevac, Clinic of Psychiatry

    Kragujevac, 34000

  • Klinika za psihijariju, Klinicki Centar Vojvodine

    Novi Sad, 21000

Other trials in Serbia

Croatia2 sites

  • CHC Rijeka-Clinic for Psychiatrics

    Rijeka, 51000

  • Poliklinika Neuron /Polyclinic Neuron

    Zagreb, 10000

Other trials in Croatia

Poland2 sites

  • Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala

    Gdansk, 80-438

  • NZOZ Prywatna Klinika Psychiatryczna Inventiva

    Tuszyn, 95-080

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Brexpiprazole
Keywords
Bipolar, Mania, Brexpiprazole
Medical subject headings
Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrexpiprazoleDrug

    Also called OPC-34712

    Brexpiprazole tablets

Study groups in NCT03287869
Study groupRoleWhat they receive
BrexpiprazoleExperimentalBrexpiprazole 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.
Receives: Drug: Brexpiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2017
  2. Study start24 Oct 2017
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel groups
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)
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03287869
Sponsor's protocol ID
331-201-00083
Other IDs
2017-002225-38, 2017
Status last verified
Aug 2020
First submitted
24 Aug 2017
Last updated
17 Aug 2020
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brexpiprazole in people with Bipolar I Disorder and Acute Mania, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Ukraine, Bulgaria, Serbia, Croatia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03287869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in