Clinical trial NCT03198078: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Brexpiprazole
Schizophrenia
Adolescent
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2017-06-23
Enrollment: 316
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety \& efficacy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in PANSS Positive and Negative Sub-Scales Scores
timeFrame: Baseline to Week 6
measure: Percentage of Participants Achieving Response
timeFrame: Up to 6 weeks
measure: Percentage of Participants Achieving Remission
timeFrame: Up to 6 weeks
measure: Change From Baseline to Week 6 in Children's Global Assessment Scale (CGAS) Total Score
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in Clinical Global Impression Severity (CGI-S) Scale Score
timeFrame: Baseline to Week 6
measure: Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 6
timeFrame: Week 6
measure: Number of Participants With Adverse Events (AEs) and Trial Discontinuation Due to AEs
timeFrame: From the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)
measure: Number of Participants With Treatment-emergent AEs (TEAEs), Serious TEAEs, and TEAEs Graded by Severity
timeFrame: From the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)
measure: Mean Change From Baseline in Weight
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Mean Change From Baseline in Height
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Mean Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Mean Change From Baseline in Waist Circumference
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)
measure: Number of Participants With Potentially Clinically Relevant Laboratory Test Values
timeFrame: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)
measure: Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs
timeFrame: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters
timeFrame: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score
timeFrame: Baseline up to last visit (approximately 6 weeks)
measure: Number of Participants With Severe Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale
timeFrame: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)
measure: Number of Participants With Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)
timeFrame: From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Oklahoma
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Caroline Ward, PhD.
role: STUDY_DIRECTOR
References: