Back to resultsTrial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brexpiprazole (OPC-34712)
Aripiprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Brexpiprazole, Schizophrenia, Adolescent
Eligibility Criteria
Inclusion Criteria:
- Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, 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.
- PANSS score >= 80, inclusive, at screening and baseline
Exclusion Criteria:
- Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
- 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 a current exacerbation of schizophrenia at the time of baseline.
- 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
Sites / Locations
- For additional information regarding sites, contact 844-687-8522
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Brexpiprazole (OPC-34712)
Aripiprazole
Placebo
Arm Description
2-4 mg/day; Start at 0.5 mg/day, titrate to max of 4 mg/day
10-20 mg/day; Start at 2 mg per day, titrate up to max of 20 mg/day
Matching placebo, daily
Outcomes
Primary Outcome Measures
Change from baseline in Positive and Negative Syndrome Scale (PANSS) Score
Secondary Outcome Measures
Overall change in Positive and Negative Subscale Scores
PANSS Response Percentage
Response defined as at least 30% improvement from baseline in PANSS Total Score
Change in Children's Global Assessment Scale (CGAS) Score
Change in Clinical Global Impression Severity (CGI-S) Score
Change in Clinical Global Impression Improvement (CGI-I) Score
Frequency of Adverse Events (AEs), Serious AEs (clinical & laboratory) [Safety]
Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE
Physical Exam [Safety]
Physical exams will be performed to assess any changes in subject over the course of the study
Vital Signs [Safety]
Change in vital signs will be assessed for any notable differences from baseline
Weight [Safety]
Change in weight, in kilograms, will be assessed for any notable differences from baseline
Height [Safety]
Change in height, in centimeters, will be assessed for any notable differences from baseline
Body Mass Index (BMI) [Safety]
Measured in kg/m^2 and assessed to determine any notable differences from baseline
Waist Circumference [Safety]
Change in waist circumference, in centimeters will be assessed for any notable differences from baseline
Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Changes in Clinical Laboratory tests (hematology, serum chemistry [including blinded prolactin] and urinalysis) Results [Safety]
Changes in ECG [Safety]
Changes in Simpson Angus Scale (SAS) Scores [Safety]
Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]
Change in Barnes Akathisia Rating Scale (BARS) Scores [Safety]
Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety]
Cognitive Adverse effects assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety]
Full Information
NCT ID
NCT03198078
First Posted
June 20, 2017
Last Updated
April 14, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT03198078
Brief Title
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Brexpiprazole, Schizophrenia, Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety & efficacy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brexpiprazole (OPC-34712)
Arm Type
Experimental
Arm Description
2-4 mg/day; Start at 0.5 mg/day, titrate to max of 4 mg/day
Arm Title
Aripiprazole
Arm Type
Active Comparator
Arm Description
10-20 mg/day; Start at 2 mg per day, titrate up to max of 20 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, daily
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole (OPC-34712)
Intervention Description
Once-daily, tablets
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Once-daily, tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once-daily, tablets
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) Score
Time Frame
Up to 6 weeks or early termination
Secondary Outcome Measure Information:
Title
Overall change in Positive and Negative Subscale Scores
Time Frame
Up to 6 weeks or early termination
Title
PANSS Response Percentage
Description
Response defined as at least 30% improvement from baseline in PANSS Total Score
Time Frame
Up to 6 weeks or early termination
Title
Change in Children's Global Assessment Scale (CGAS) Score
Time Frame
Up to 6 weeks or early termination
Title
Change in Clinical Global Impression Severity (CGI-S) Score
Time Frame
Up to 6 weeks or early termination
Title
Change in Clinical Global Impression Improvement (CGI-I) Score
Time Frame
Up to 6 weeks or early termination
Title
Frequency of Adverse Events (AEs), Serious AEs (clinical & laboratory) [Safety]
Description
Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE
Time Frame
Up to 6 weeks or early termination with a 21 day follow-up period
Title
Physical Exam [Safety]
Description
Physical exams will be performed to assess any changes in subject over the course of the study
Time Frame
Up to 6 weeks or early termination
Title
Vital Signs [Safety]
Description
Change in vital signs will be assessed for any notable differences from baseline
Time Frame
Up to 6 weeks or early termination
Title
Weight [Safety]
Description
Change in weight, in kilograms, will be assessed for any notable differences from baseline
Time Frame
Up to 6 weeks or early termination
Title
Height [Safety]
Description
Change in height, in centimeters, will be assessed for any notable differences from baseline
Time Frame
Up to 6 weeks or early termination
Title
Body Mass Index (BMI) [Safety]
Description
Measured in kg/m^2 and assessed to determine any notable differences from baseline
Time Frame
Up to 6 weeks or early termination
Title
Waist Circumference [Safety]
Description
Change in waist circumference, in centimeters will be assessed for any notable differences from baseline
Time Frame
Up to 6 weeks or early termination
Title
Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Time Frame
Up to 6 weeks or early termination
Title
Changes in Clinical Laboratory tests (hematology, serum chemistry [including blinded prolactin] and urinalysis) Results [Safety]
Time Frame
Up to 6 weeks or early termination
Title
Changes in ECG [Safety]
Time Frame
Up to 6 weeks or early termination
Title
Changes in Simpson Angus Scale (SAS) Scores [Safety]
Time Frame
Up to 6 weeks or early termination
Title
Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]
Time Frame
Up to 6 weeks or early termination
Title
Change in Barnes Akathisia Rating Scale (BARS) Scores [Safety]
Time Frame
Up to 6 weeks or early termination
Title
Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety]
Time Frame
Up to 6 weeks or early termination
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, 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.
PANSS score >= 80, inclusive, at screening and baseline
Exclusion Criteria:
Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
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 a current exacerbation of schizophrenia at the time of baseline.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Ward, PhD.
Organizational Affiliation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
We'll reach out to this number within 24 hrs