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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03259555
Other study ID # 331-201-00080
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 14, 2017
Est. completion date January 2, 2019

Study information

Verified date February 2020
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.


Description:

A multicenter, randomized, double-blind trial of brexpiprazole versus placebo for the acute treatment of manic episodes, with or without mixed features, associated with bipolar I disorder. This study also demonstrated the safety and tolerability of brexpiprazole in the study population of males and females aged 18 to 65 years (inclusive, at time of consent).


Recruitment information / eligibility

Status Completed
Enrollment 322
Est. completion date January 2, 2019
Est. primary completion date January 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Male or female participants, ages 18 to 65 years, inclusive, at the time of informed consent.

- Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.

- Participants with a Diagnostic & Statistical Manual on Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar I disorder displaying an acute manic episode with or without mixed features requiring hospitalization. Diagnosis confirmed by the MINI International Neuropsychiatric Interview and a history of at least 1 previous manic episode with or without mixed features with manic symptoms of sufficient severity to require one of the following interventions: hospitalization or treatment with a mood stabilizer, or treatment with an antipsychotic agent. "Require" was defined as an intervention that occurred rather than one that was recommended.

- Young-mania rating scale (YMRS) score of =24 at screening and baseline.

Exclusion Criteria:

- Sexually active male or women of childbearing potential who did not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product.

- Females who were breastfeeding and/or who had a positive pregnancy test result prior to receiving trial medication.

- Participants considered unresponsive to clozapine or who were only responsive to clozapine.

- Participants with a history of DSM-5 diagnosis other than bipolar I disorder, including schizophrenia, schizoaffective disorder, major depressive disorder, attention-deficit/hyperactivity disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. All other current diagnoses must have been discussed with the medical monitor.

- Participants whose current manic episode had lasted for more than 4 weeks overall, or who had required hospitalization >21 days for the current acute episode at the time of the screening visit, excluding hospitalization for psychosocial reasons.

- Participant with manic symptoms better accounted for by another general medical condition or direct physiological effect of substance (for example, medication).

- Participants who have had electroconvulsive treatment within the past 2 months.

- Participants with a positive drug screen for cocaine or other illicit drugs.

- Abnormal laboratory test results, vital signs or electrocardiogram findings, unless based on investigator's judgment the findings are not medically significant or would not impact the safety of the participant or the interpretation of the trial results.

- Rapid cyclers with more than 6 episodes in the previous year.

- Participants with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days) or an abnormal result for free thyroxine at screening.

- Participants with uncontrolled hypertension or symptomatic hypotension or orthostatic hypotension.

- Participant with epilepsy or history of seizures.

- Participants who participated in a clinical trial within the last 60 days or who participated in more than 2 clinical trials within the past year.

- Use of psychotropic medications (other than benzodiazepines) within 7 days of the baseline YMRS.

- Participants who currently had clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.

- Participants who received brexpiprazole in any prior clinical trial or currently taking commercially available brexpiprazole (Rexulti).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Brexpiprazole
Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.
Placebo
Administered orally daily for 3 weeks.

Locations

Country Name City State
Bulgaria Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD Burgas
Bulgaria State Psychiatry Hospital - Kardzhali Kardzhali
Bulgaria State Psychiatry Hospital Sv. Ivan Rilski Novi Iskar
Bulgaria University Multiprofile Hospital for Active Treatment Sveti Georgi EAD Plovdiv
Bulgaria Mental Health Center - Ruse EOOD Ruse
Bulgaria University Multiprofile Hospital for Active Treatment Alexandrovska EAD Sofia
Bulgaria Multiprofile Hospital for Active Treatment - Targovishte AD Targovishte
Bulgaria Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo
Bulgaria Mental Health Center - Vratsa EOOD Vratsa
Poland Samodzielny Publiczny Psychiatryczny Zaklad Opieki Zdrowotnej im. Dr. Stanislawa Deresza w Choroszczy Choroszcz
Poland Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Psychiatrii Doroslych Gdansk
Poland NZOZ Centrum Medyczne HCP Sp. z o. o. Poznan
Poland NZOZ Prywatna Klinika Psychiatryczna Inventiva Tuszyn
Serbia Clinic for Psychiatric Disorders Dr Laza Lazarevic Belgrade
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Hospital Center Dr Dragisa Misovic-Dedinje Belgrade
Serbia Special Hospital for Psychiatric Diseases Kovin Kovin
Serbia Clinical Center Kragujevac Kragujevac
Serbia Clinical Center of Vojvodina Novi Sad
United States Radiant Research Inc. Atlanta Georgia
United States Community Clinical Research, Inc. Austin Texas
United States University of Texas at Austin Austin Texas
United States Carolina Clinical Trials, Inc. Charleston South Carolina
United States ProScience Research Group Culver City California
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 Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois
United States Advanced Research Institute of Miami Homestead Florida
United States Florida Behavioral Medicine Largo Florida
United States Woodland International Research Group Little Rock Arkansas
United States Optimus U Corporation Miami Florida
United States Behavioral Clinical Research, Inc. North Miami Florida
United States Segal Trials North Miami Florida
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 Panorama City California
United States Richard H Weisler, MD, PA, and 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 Advanced Clinical Research Center, LLC Saint Louis Missouri
United States Sharp Vista Hospital San Diego California

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline In Young-Mania Rating Scale (YMRS) Score At Week 3 The YMRS was utilized to assess a participant's level of manic symptoms. It consists of 11 items: 1) elevated mood, 2) increased motor activity-energy, 3) sexual interest, 4) sleep, 5) irritability, 6) speech (rate and amount), 7) language-thought disorder, 8) content, 9) disruptive-aggressive behavior, 10) appearance, and 11) insight. Seven items are rated on a 0- to 4-scale, while four items (Items 5, 6, 8, and 9) are rated on a 0- to 8-scale with 0, 2, 4, 6, and 8 being the possible scores (twice the weight of the other items). For all items, 0 is the "best" rating and the highest score (4 or 8) is the 'worst' rating. The YMRS total score is the sum of ratings for all 11 items; therefore, possible total scores range from 0 to 60, with higher scores signifying more severe manic symptoms. Comparison between treatment groups was carried out using mixed-effect model repeated measure (MMRM). Baseline, Week 3
Secondary Change From Baseline In Clinical Global Impression-Bipolar (CGI-BP) Severity Score In Mania At Week 3 The CGI-BP scale refers to the global impression of the participant with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP severity of illness: mania, depression, and overall bipolar illness) based on a 7-point scale: 1 = normal, not at all ill, 2 = minimally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = very severely ill. Baseline, Week 3
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