Journal of the American Academy of Child and Adolescent Psychiatry · 2026
Influence of Age and Gender on Short-Term Efficacy, Acceptability, and Safety of Antipsychotic Drug Treatment of Adolescents With Schizophrenia: An Individual Patient Data Meta-Analysis.
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Storosum Bram W C, Cohen Sem E, Tilkema Nynke, Mattila Taina K, van den Brink Wim, de Haan L, Denys Damiaan A J P, Zantvoord Jasper B
Аннотация
OBJECTIVE: To investigate whether age or gender moderates short-term antipsychotic efficacy, acceptability, or safety in adolescents with early-onset schizophrenia (EOS).
METHOD: We analyzed data from 4 placebo-controlled, randomized registration trials of antipsychotics in EOS (2003-2015). An individual patient data meta-analysis evaluated how age and gender affected efficacy (Positive and Negative Syndrome Scale [PANSS] total change, response), acceptability (all-cause discontinuations), and safety (adverse event incidence). Covariates included age at onset, body mass index, baseline negative symptoms, and study year. The study was registered in the PROSPERO database (ID: CRD42024572863).
RESULTS: We included 949 adolescents (61% male, 39% female; mean age = 15.4 years). Neither age (β = 0.251, 95% CI= -1.561-2.064) nor gender (β = 3.057, 95% CI = -0.206-8.175) significantly altered overall antipsychotic efficacy on mean PANSS improvement or response rate. All-cause discontinuation was likewise not affected. Younger adolescents on active medication showed a higher incidence of adverse events than those on placebo, whereas older adolescents exhibited similarly low rates across arms (correlation coefficient = -0.272, p < .001). Gender did not significantly influence adverse-event incidence (aggregate β = 0,037, p = .832). The overall correlation coefficient -0.131 (p = .342) between age and 5 major side effect classes (weight gain, extrapyramidal side effects, QTc prolongation, prolactin increase, sedation) suggested no meaningful age impact, with odds ratios ranging from 0.858 (p = .691) for weight gain to 1.244 (p = .225) for sedation.
CONCLUSION: Younger adolescents demonstrated greater vulnerability to antipsychotic-related adverse events despite exhibiting efficacy and acceptability comparable to those in older adolescents. These findings suggest that age-based dosing and monitoring may be warranted when treating adolescents with EOS.
STUDY REGISTRATION INFORMATION: Influence of age and gender on short-term efficacy and safety of antipsychotic drugs in the treatment of adolescents with schizophrenia: an Individual Patients Data Meta-Analysis; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024572863 DIVERSITY & INCLUSION STATEMENT: We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group.
METHOD: We analyzed data from 4 placebo-controlled, randomized registration trials of antipsychotics in EOS (2003-2015). An individual patient data meta-analysis evaluated how age and gender affected efficacy (Positive and Negative Syndrome Scale [PANSS] total change, response), acceptability (all-cause discontinuations), and safety (adverse event incidence). Covariates included age at onset, body mass index, baseline negative symptoms, and study year. The study was registered in the PROSPERO database (ID: CRD42024572863).
RESULTS: We included 949 adolescents (61% male, 39% female; mean age = 15.4 years). Neither age (β = 0.251, 95% CI= -1.561-2.064) nor gender (β = 3.057, 95% CI = -0.206-8.175) significantly altered overall antipsychotic efficacy on mean PANSS improvement or response rate. All-cause discontinuation was likewise not affected. Younger adolescents on active medication showed a higher incidence of adverse events than those on placebo, whereas older adolescents exhibited similarly low rates across arms (correlation coefficient = -0.272, p < .001). Gender did not significantly influence adverse-event incidence (aggregate β = 0,037, p = .832). The overall correlation coefficient -0.131 (p = .342) between age and 5 major side effect classes (weight gain, extrapyramidal side effects, QTc prolongation, prolactin increase, sedation) suggested no meaningful age impact, with odds ratios ranging from 0.858 (p = .691) for weight gain to 1.244 (p = .225) for sedation.
CONCLUSION: Younger adolescents demonstrated greater vulnerability to antipsychotic-related adverse events despite exhibiting efficacy and acceptability comparable to those in older adolescents. These findings suggest that age-based dosing and monitoring may be warranted when treating adolescents with EOS.
STUDY REGISTRATION INFORMATION: Influence of age and gender on short-term efficacy and safety of antipsychotic drugs in the treatment of adolescents with schizophrenia: an Individual Patients Data Meta-Analysis; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024572863 DIVERSITY & INCLUSION STATEMENT: We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group.