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

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287869
• Other study ID #: 331-201-00083
• Secondary ID: 2017-002225-38
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2020
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.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

Related Conditions & MeSH terms

• Acute Mania
• Bipolar I Disorder
• Disease

Intervention

Drug:
• Brexpiprazole
Brexpiprazole tablets

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Poland,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up)