The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this "early-onset schizophrenia" exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Culver City, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Reported Adverse Events (AEs) at 30 day Follow-Up
Time frame: 30 day Follow-Up
Change from Baseline to Day 17 in Vital Signs
Time frame: Baseline to Day 17
Change from Baseline to Day 17 ECGs
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Hematology
Time frame: Baseline to Day 17
Change from Baseline to Day 14 Physical examination
Time frame: Baseline to Day 14
Change from Baseline to Day 17 Body weight
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Serum chemistry
Including Prolactin concentrations
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Urinalysis
Time frame: Baseline to Day 17
Maximal peak steady-state plasma concentration
Time frame: At Day 14
Minimum trough steady-state plasma concentration
Time frame: At Day 14
Time to maximum peak steady-state plasma concentration
Time frame: At Day 14
Area under the concentration-time curve during the dosing interval at steady-state
Time frame: At Day 14
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Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Marlton, New Jersey, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
The Woodlands, Texas, United States
Unnamed facility
Orem, Utah, United States
Terminal elimination half-life
Time frame: At Day 14
For Brex only, apparent cleanse and apparent volume of distribution
Time frame: At Day 14
Mean change in CGI-S score
Time frame: Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase
Mean change in CGI-I score
Time frame: Day 7 and Day 14
Glycosylated haemoglobin [HbA1c]
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH]
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Cortisol
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Thyroid stimulating hormone [TSH]
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Prothrombin time [PT]
Time frame: Baseline to Day 17
Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT]
Time frame: Baseline to Day 17
Change from Baseline to Day 17 International normalized ratio [INR]
Time frame: Baseline to Day 17
For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS)
Time frame: Day-1 to Day 15
For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS)
Time frame: Day -1 to Day 15