Positive Results for Brexpiprazole in Youth Schizophrenia
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on June 6th, 2025
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Schizophrenia in children often presents with more severe symptoms and a poorer prognosis compared to adults. While there are effective antipsychotic treatments available for children and adolescents, these agents tend to carry higher risks in younger patients. Recent studies have suggested that beyond dopamine, other monoamine neurotransmitters—such as norepinephrine and serotonin—also contribute to the pathophysiology of schizophrenia. With funding from Otsuka Pharmaceutical, a study was conducted to evaluate the use of brexpiprazole in managing pediatric schizophrenia.
The phase 3 clinical trial enrolled 316 adolescents aged 13 to 17 years who were diagnosed with schizophrenia according to DSM-5 criteria. At baseline, participants had a mean score of approximately 100 on the Positive and Negative Syndrome Scale (PANSS), where a maximum score of 210 indicates the most severe form of the disease. Additional assessments showed an average Children’s Global Assessment Scale (CGAS) score of 48 and a Clinical Global Impressions–Severity (CGI-S) score of 4.7.
Participants were randomly assigned to receive either a placebo, brexpiprazole (2–4 mg daily), or aripiprazole (10–20 mg daily). Aripiprazole served as an active control, having previously demonstrated efficacy and tolerability in this population. All participants received concurrent psychotherapy, and prior antipsychotic medications were discontinued at least three days before treatment initiation.
After six weeks, both brexpiprazole and aripiprazole significantly reduced the severity of schizophrenia symptoms, each producing an average 23-point reduction in PANSS scores—compared to a 17.4-point reduction in the placebo group. Improvements were mainly observed in positive symptoms and general psychopathology, while no significant changes were seen in negative symptoms. Similarly, no notable differences were found in CGI-S or CGAS scores. Although the results are promising, limitations include the short duration of the study and a lack of diversity in the participant population, particularly the underrepresentation of Asian individuals.
The phase 3 clinical trial enrolled 316 adolescents aged 13 to 17 years who were diagnosed with schizophrenia according to DSM-5 criteria. At baseline, participants had a mean score of approximately 100 on the Positive and Negative Syndrome Scale (PANSS), where a maximum score of 210 indicates the most severe form of the disease. Additional assessments showed an average Children’s Global Assessment Scale (CGAS) score of 48 and a Clinical Global Impressions–Severity (CGI-S) score of 4.7.
Participants were randomly assigned to receive either a placebo, brexpiprazole (2–4 mg daily), or aripiprazole (10–20 mg daily). Aripiprazole served as an active control, having previously demonstrated efficacy and tolerability in this population. All participants received concurrent psychotherapy, and prior antipsychotic medications were discontinued at least three days before treatment initiation.
After six weeks, both brexpiprazole and aripiprazole significantly reduced the severity of schizophrenia symptoms, each producing an average 23-point reduction in PANSS scores—compared to a 17.4-point reduction in the placebo group. Improvements were mainly observed in positive symptoms and general psychopathology, while no significant changes were seen in negative symptoms. Similarly, no notable differences were found in CGI-S or CGAS scores. Although the results are promising, limitations include the short duration of the study and a lack of diversity in the participant population, particularly the underrepresentation of Asian individuals.