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Trial to Evaluate the Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03198078
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Brexpiprazole (OPC-34712) Drug: Aripiprazole Drug: Placebo Phase 3

Detailed Description:
This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety & efficacy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Brexpiprazole (OPC-34712)
2-4 mg/day; Start at 0.5 mg/day, titrate to max of 4 mg/day
Drug: Brexpiprazole (OPC-34712)
Once-daily, tablets

Active Comparator: Aripiprazole
10-20 mg/day; Start at 2 mg per day, titrate up to max of 20 mg/day
Drug: Aripiprazole
Once-daily, tablets

Placebo Comparator: Placebo
Matching placebo, daily
Drug: Placebo
Once-daily, tablets




Primary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) Score [ Time Frame: Up to 6 weeks or early termination ]

Secondary Outcome Measures :
  1. Overall change in Positive and Negative Subscale Scores [ Time Frame: Up to 6 weeks or early termination ]
  2. PANSS Response Percentage [ Time Frame: Up to 6 weeks or early termination ]
    Response defined as at least 30% improvement from baseline in PANSS Total Score

  3. Change in Children's Global Assessment Scale (CGAS) Score [ Time Frame: Up to 6 weeks or early termination ]
  4. Change in Clinical Global Impression Severity (CGI-S) Score [ Time Frame: Up to 6 weeks or early termination ]
  5. Change in Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: Up to 6 weeks or early termination ]
  6. Frequency of Adverse Events (AEs), Serious AEs (clinical & laboratory) [Safety] [ Time Frame: Up to 6 weeks or early termination with a 21 day follow-up period ]
    Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE

  7. Physical Exam [Safety] [ Time Frame: Up to 6 weeks or early termination ]
    Physical exams will be performed to assess any changes in subject over the course of the study

  8. Vital Signs [Safety] [ Time Frame: Up to 6 weeks or early termination ]
    Change in vital signs will be assessed for any notable differences from baseline

  9. Weight [Safety] [ Time Frame: Up to 6 weeks or early termination ]
    Change in weight, in kilograms, will be assessed for any notable differences from baseline

  10. Height [Safety] [ Time Frame: Up to 6 weeks or early termination ]
    Change in height, in centimeters, will be assessed for any notable differences from baseline

  11. Body Mass Index (BMI) [Safety] [ Time Frame: Up to 6 weeks or early termination ]
    Measured in kg/m^2 and assessed to determine any notable differences from baseline

  12. Waist Circumference [Safety] [ Time Frame: Up to 6 weeks or early termination ]
    Change in waist circumference, in centimeters will be assessed for any notable differences from baseline

  13. Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  14. Changes in Clinical Laboratory tests (hematology, serum chemistry [including blinded prolactin] and urinalysis) Results [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  15. Changes in ECG [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  16. Changes in Simpson Angus Scale (SAS) Scores [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  17. Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  18. Change in Barnes Akathisia Rating Scale (BARS) Scores [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  19. Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety] [ Time Frame: Up to 6 weeks or early termination ]
  20. Cognitive Adverse effects assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety] [ Time Frame: Up to 6 weeks or early termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male & female subjects aged 13-17 years, inclusive at time of consent with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
  • Subjects have shown previous response to antipsychotic treatment other than clozapine.
  • Subjects with a history of relapse or exacerbation of symptoms when not receiving antipsychotic treatment
  • Outpatient status at screening and within 21 days of baseline visit.
  • PANSS score >= 80, inclusive, at screening and baseline

Exclusion Criteria:

  • Subjects with a current primary DSM-5 diagnosis other than schizophrenia, including any DSM-5 current diagnosis of schizoaffective disorder or current diagnosis of major depressive disorder, PTSD, or bipolar disorder with or without psychotic features
  • Subjects with any of the following DSM-5 diagnoses: borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
  • Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia or other cognitive disorders
  • Subjects who have been hospitalized > 21 days for acute exacerbation of schizophrenia at the time of the baseline visit
  • Any neurological disorder other than Tourette's Syndrome
  • Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
  • Subjects with epilepsy, a history of seizures, severe head trauma or stroke
  • Subjects who test positive for drugs of abuse at screening

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): NCT03198078


Contacts
Contact: Jennifer Pokorny +1-919-745-2685 Jennifer.Pokorny@INCResearch.com

Locations
United States, Alabama
Harmonex Neuroscience Research Recruiting
Dothan, Alabama, United States, 36303
United States, California
CMB Clinical Trials LLC Recruiting
Colton, California, United States, 92324
ProScience Research Group Recruiting
Culver City, California, United States, 90230
Alliance for Wellness dba Alliance for Research Recruiting
Long Beach, California, United States, 90807
United States, Connecticut
Institute of Living Recruiting
Hartford, Connecticut, United States, 06106
United States, Florida
Reliable Clinical Research, LLC Recruiting
Hialeah, Florida, United States, 33012
United States, Georgia
Atlanta Behavioral Research, LLC Recruiting
Atlanta, Georgia, United States, 30388
United States, New York
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
United States, North Carolina
New Hope Clinical Research Recruiting
Charlotte, North Carolina, United States, 28211
United States, Ohio
Charak Clinical Research Center Recruiting
Garfield Heights, Ohio, United States, 44125
United States, Oklahoma
Red River Medical Research Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
BioBehavioral Research of Austin P.C. Recruiting
Austin, Texas, United States, 78759
Red Oak Psychiatry Associates Recruiting
Houston, Texas, United States, 77090
United States, Washington
Eastside Therapeutic Resource dba Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Investigators
Study Director: Eva Kohegyi, M.D. Otsuka Pharamceutical Development & Commercialization, Inc.

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03198078     History of Changes
Other Study ID Numbers: 331-10-234
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 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
Schizophrenia
Adolescent

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Brexpiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Agonists
Dopamine Agents