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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03198078

Collaborator

H. Lundbeck A/S (Industry)

480

Enrollment

Location

Arms

87.1

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

480 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 & efficacySubjects 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 :

Jun 30, 2017

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale (PANSS) Score [Up to 6 weeks or early termination]

Secondary Outcome Measures

Overall change in Positive and Negative Subscale Scores [Up to 6 weeks or early termination]
PANSS Response Percentage [Up to 6 weeks or early termination]
Response defined as at least 30% improvement from baseline in PANSS Total Score
Change in Children's Global Assessment Scale (CGAS) Score [Up to 6 weeks or early termination]
Change in Clinical Global Impression Severity (CGI-S) Score [Up to 6 weeks or early termination]
Change in Clinical Global Impression Improvement (CGI-I) Score [Up to 6 weeks or early termination]
Frequency of Adverse Events (AEs), Serious AEs (clinical & laboratory) [Safety] [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
Physical Exam [Safety] [Up to 6 weeks or early termination]
Physical exams will be performed to assess any changes in subject over the course of the study
Vital Signs [Safety] [Up to 6 weeks or early termination]
Change in vital signs will be assessed for any notable differences from baseline
Weight [Safety] [Up to 6 weeks or early termination]
Change in weight, in kilograms, will be assessed for any notable differences from baseline
Height [Safety] [Up to 6 weeks or early termination]
Change in height, in centimeters, will be assessed for any notable differences from baseline
Body Mass Index (BMI) [Safety] [Up to 6 weeks or early termination]
Measured in kg/m^2 and assessed to determine any notable differences from baseline
Waist Circumference [Safety] [Up to 6 weeks or early termination]
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] [Up to 6 weeks or early termination]
Changes in Clinical Laboratory tests (hematology, serum chemistry [including blinded prolactin] and urinalysis) Results [Safety] [Up to 6 weeks or early termination]
Changes in ECG [Safety] [Up to 6 weeks or early termination]
Changes in Simpson Angus Scale (SAS) Scores [Safety] [Up to 6 weeks or early termination]
Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety] [Up to 6 weeks or early termination]
Change in Barnes Akathisia Rating Scale (BARS) Scores [Safety] [Up to 6 weeks or early termination]
Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety] [Up to 6 weeks or early termination]
Cognitive Adverse effects assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety] [Up to 6 weeks or early termination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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