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A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT03259555
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
To Demonstrate the Efficacy of Brexpiprazole for the Acute Treatment of Manic Episodes, With or Without Mixed Features, in Subjects with a Diagnosis of Bipolar I Disorder

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Manic Episode Drug: Brexpiprazole Drug: Placebo Phase 3

Detailed 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 will also demonstrate the safety and tolerability of brexpiprazole in the study population of males and females aged 18 to 65 years (inclusive, at time of consent).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will receive a dose of brexpiprazole or placebo and be evaluated throughout the duration of the study; a maximum of 21 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Trial of Brexpiprazole Versus Placebo for the Acute Treatment Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole
Daily, oral, tablet
Drug: Brexpiprazole
Starting dose of 2 mg/day; titrated to a max of 4 mg/day. Adjustments can be made to dosing

Placebo Comparator: Placebo
Daily, oral, tablet
Drug: Placebo
Tablet taken daily




Primary Outcome Measures :
  1. Change from baseline in Young-Mania Rating Scale (YMRS) Score [ Time Frame: Up to 21 days or early termination ]

Secondary Outcome Measures :
  1. Change from baseline in Clinical Global Impression-Bipolar (CGI-BP) severity of illness score in mania [ Time Frame: Up to 21 days or early termination ]
  2. Change from baseline in YMRS score for each trial visit [ Time Frame: Up to 14 days or early termination ]
  3. Change from baseline in CGI-BP severity of illness score in mania for each trial visit [ Time Frame: Up to 14 days or early termination ]
  4. Change from baseline in mania for CGI-BP at each trial visit [ Time Frame: Up to 21 days or early termination ]
  5. YMRS response rate for each trial visit [ Time Frame: Up to 21 days or early termination ]
    Response is defined as ≥ 50% reduction in YMRS total score from baseline or total score ≤ 12

  6. YMRS remission rate for each trial visit [ Time Frame: Up to 21 days or early termination ]
    Remission is defined as YMRS score ≤ 12%

  7. CGI-BP change from baseline score at each trial visit [ Time Frame: Up to 21 days or early termination ]
    Response is defined as a CGI-BP change in baseline score in mania of 1 or 2


Other Outcome Measures:
  1. Change from baseline in Montgomery Asberg Depression Score (MADRS) [ Time Frame: Up to 7 days ]
  2. Global Assessment of Functioning (GAF) score [ Time Frame: Up to 21 days or early termination ]
    Will assess change from baseline in score

  3. Adverse Events (AEs) [Safety] [ Time Frame: Up to 21 days or early termination with a 21 day follow-up period ]
    Occurrence of AEs will be reviewed for notable observations or trends

  4. Clinical Laboratory Tests [Safety] [ Time Frame: Up to 21 days or early termination ]
    Hematology, serum chemistry (including prolactin & glycosylated hemoglobin) coagulation parameters, & urinalysis. Lab results will be assessed for notable observations or changes

  5. Physical examination (including weight & waist circumference) [Safety] [ Time Frame: Up to 21 days or early termination ]
    Subject will be examined for any notable observations or changes

  6. Vital Signs [Safety] [ Time Frame: Up to 21 days or early termination ]
    Vital signs will be assessed for any notable measurements or changes

  7. ECGs [Safety] [ Time Frame: Up to 21 days or early termination ]
    ECGs will be assessed for any notable measurements or changes

  8. Simpson-Angus Scale (SAS) total score [Safety] [ Time Frame: Up to 21 days or early termination ]
    Used in the assessment of extrapyramidal symptoms (EPS)

  9. Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score [Safety] [ Time Frame: Up to 21 days or early termination ]
    Used in the assessment of extrapyramidal symptoms (EPS)

  10. Barnes Akathisia Rating Scale (BARS) Global Score [ Time Frame: Up to 21 days or early termination ]
    Used in the assessment of extrapyramidal symptoms (EPS)

  11. Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety] [ Time Frame: Up to 21 days or early termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, ages 18 to 65 years, inclusive, at the time of informed consent.
  • Subjects willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
  • Subjects 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 and a history of at least one 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" is defined as an intervention that occurred rather than one that was recommended.
  • YMRS score of ≥ 24 at screening & baseline

Exclusion Criteria:

  • Sexually active male or WOCBP (women of childbearing potential) who do 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 IMP.
  • Females who are breastfeeding and/or who have a positive pregnancy test result prior to receiving trial medication.
  • Subjects considered unresponsive to clozapine or who are only responsive to cloazapine.
  • Subjects 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, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. All other current diagnoses must be discussed with the medical monitor.
  • Subjects whose current manic episode has lasted for more than 4 weeks overall, or who have required hospitalization > 21 days for the current acute episode at the time of the screening visit, excluding hospitalization for psychosocial reasons.
  • Subject with manic symptoms better accounted for by another general medical condition or direct physiological effect of substance (eg. medication)
  • Subjects who have had electroconvulsive treatment within the past 2 months.
  • Subjects with a positive drug screen for cocaine or other illicit drugs
  • Abnormal laboratory test results, vital signs or ECG results, unless based on investigator's judgment the findings are not medically significant or would not affect the trial results.
  • Rapid cyclers with more than 6 episodes in previous year
  • Subjects with uncontrolled hypo/hyperthyroidism
  • Subjects with uncontrolled hypertension or symptomatic hypotension or orthostatic hypotension.
  • Subject with epilepsy or history of seizures
  • Subjects 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.
  • Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders
  • Subjects who received brexpiprazole in any prior clinical trial or currently taking commercially available brexpiprazole (Rexulti®).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259555


Contacts
Contact: Phyllis Aldridge +1 (484) 455-7074 Phyllis.Aldridge@SyneosHealth.com

Locations
United States, Arkansas
Woodland International Research Group Recruiting
Little Rock, Arkansas, United States, 72211
Woodland Research Northwest, LLC Recruiting
Rogers, Arkansas, United States, 72758
United States, California
ProScience Research Group Recruiting
Culver City, California, United States, 90230
Collaborative Neuroscience Network, LLC Recruiting
Garden Grove, California, United States, 92845
Behavioral Research Specialist, LLC Recruiting
Glendale, California, United States, 91206
Pacific Research Partners, LLC Recruiting
Oakland, California, United States, 94607
NRC Research Institute Recruiting
Orange, California, United States, 92868
Asclepes Research Centers PC Recruiting
Panorama City, California, United States, 91402
CI Trials Recruiting
Riverside, California, United States, 92705
Sharp Mesa Vista Hospital Recruiting
San Diego, California, United States, 92123
United States, Florida
Innovative Clinical Research, Inc. Recruiting
Fort Lauderdale, Florida, United States, 33308
Galiz Research Not yet recruiting
Hialeah, Florida, United States, 33016
Behavioral Clinical Research Not yet recruiting
Hollywood, Florida, United States, 33021
Advanced Research Institute of Miami Recruiting
Homestead, Florida, United States, 33030
Florida Behavioral Medicine Not yet recruiting
Largo, Florida, United States, 33770
United States, Georgia
Radiant Research Inc. Recruiting
Atlanta, Georgia, United States, 30328
United States, Illinois
Alexian Brothers Center for Psychiatric Research Recruiting
Hoffman Estates, Illinois, United States, 60169
United States, Maryland
CBH Health Recruiting
Gaithersburg, Maryland, United States, 20877
United States, North Carolina
Richard H Weisler, MD PD Associates Recruiting
Raleigh, North Carolina, United States, 27609
United States, Oklahoma
Cutting Edge Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73116
United States, South Carolina
Carolina Clinical Trials, Inc. Recruiting
Charleston, South Carolina, United States, 29405
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Pillar Clinical Research, LLC Recruiting
Richardson, Texas, United States, 75080
United States, Washington
Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Mid Columbia Research Not yet recruiting
Richland, Washington, United States, 99352
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Investigators
Study Director: Matthew Leoni, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03259555     History of Changes
Other Study ID Numbers: 331-201-00080
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Brexpiprazole
Bipolar
Manic episode

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents