Atkinson Sarah D, Shah Alpesh, Burgess Maria Victoria, Hefting Nanco, Chen Dalei, Ward Caroline
Evolution Research Group, Rochester, New York.
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey.
JAACAP Open. 2024 May 27;3(2):313-322. doi: 10.1016/j.jaacop.2024.04.005. eCollection 2025 Jun.
This study aimed to characterize long-term safety and tolerability of brexpiprazole, an atypical antipsychotic, as maintenance treatment in adolescents with schizophrenia.
This was an interim analysis of an ongoing, 24-month, multicenter, single-arm, open-label, outpatient study of oral brexpiprazole 1 to 4 mg/day (flexible dose) in adolescents aged 13 to 17 years with schizophrenia. Primary end points were incidence of treatment-emergent adverse events (TEAEs), TEAEs by severity, serious TEAEs, and adverse events leading to study discontinuation.
At the time of interim analysis, 169 patients had entered the study, 114 (67.5%) were ongoing, 23 (13.6%) had completed the full 24 months, and 32 (18.9%) had discontinued-most commonly due to withdrawal by the patient. Study participants were 52.7% female and 79.9% White, with a mean age of 15.6 years. Overall, 95 of 167 treated patients (56.9%) reported ≥1 TEAEs, most commonly somnolence (10.2%), headache (9.0%), weight increase (9.0%), and nasopharyngitis (6.6%). Most TEAEs were mild or moderate in severity. Clinically meaningful weight gain after adjusting for natural growth occurred in 33 patients (19.8%). Five patients (3.0%) reported a serious TEAE (2 psychotic disorder; 1 each of nonfatal suicide attempt, pilonidal cyst, and psychomotor hyperactivity), all of which resolved during the study. Two patients (1.2%) discontinued the study due to adverse events: one following the serious nonfatal suicide attempt and the other due to hyperpituitarism and weight increase, which were considered stable at the time of discharge.
Brexpiprazole, when used as maintenance treatment for adolescents with schizophrenia, has a safety profile generally consistent with that observed in adult patients. Any weight gain in adolescent patients should be carefully monitored and compared against weight gain associated with normal growth.
• This study aimed to answer the question of whether oral doses of brexpiprazole, 1-4 mg once-daily, were safe and tolerated maintenance treatment in adolescents with schizophrenia.• In an interim analysis of a 24-month study (67.5% of patients ongoing; 13.6% completed; 18.9% discontinued), 1.2% of adolescents with schizophrenia reported an adverse event that led to treatment discontinuation.• Clinicians should consider safety profiles when selecting an antipsychotic for the treatment of adolescents with schizophrenia; brexpiprazole has a similar safety profile in adolescents as in adults.
Safety and Tolerability of Open-Label Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia; https://www.clinicaltrials.gov/study/NCT03238326?cond=NCT03238326.
本研究旨在评估非典型抗精神病药物布瑞哌唑作为精神分裂症青少年维持治疗药物的长期安全性和耐受性。
这是一项正在进行的、为期24个月的多中心、单臂、开放标签的门诊研究的中期分析，该研究针对年龄在13至17岁的精神分裂症青少年患者口服布瑞哌唑，剂量为每日1至4毫克（灵活剂量）。主要终点为治疗中出现的不良事件（TEAE）的发生率、按严重程度划分的TEAE、严重TEAE以及导致研究中止的不良事件。
在中期分析时，169名患者进入研究，114名（67.5%）仍在进行研究，23名（13.6%）已完成全部24个月的研究，32名（18.9%）已中止研究——最常见的原因是患者退出。研究参与者中女性占52.7%，白人占79.9%，平均年龄为15.6岁。总体而言，167名接受治疗的患者中有95名（56.9%）报告了≥1次TEAE，最常见的是嗜睡（10.2%）、头痛（9.0%）、体重增加（9.0%）和鼻咽炎（6.6%）。大多数TEAE的严重程度为轻度或中度。在调整自然生长因素后，33名患者（19.8%）出现了具有临床意义的体重增加。5名患者（3.0%）报告了严重TEAE（2例为精神障碍；1例为非致命自杀未遂、1例为藏毛窦、1例为精神运动性多动），所有这些在研究期间均已缓解。2名患者（1.2%）因不良事件中止研究：1例在严重非致命自杀未遂后，另1例因垂体功能亢进和体重增加，出院时情况稳定。
布瑞哌唑作为精神分裂症青少年的维持治疗药物，其安全性概况总体上与在成年患者中观察到的情况一致。青少年患者的任何体重增加都应仔细监测，并与正常生长相关的体重增加进行比较。
• 本研究旨在回答每日口服1 - 4毫克布瑞哌唑作为精神分裂症青少年维持治疗药物是否安全且耐受的问题。
• 在一项为期24个月研究的中期分析中（67.5%的患者仍在进行研究；13.6%已完成；18.9%已中止），1.2%的精神分裂症青少年报告了导致治疗中止的不良事件。
• 临床医生在为精神分裂症青少年选择抗精神病药物时应考虑安全性概况；布瑞哌唑在青少年中的安全性概况与在成年人中相似。
开放标签灵活剂量布瑞哌唑作为精神分裂症青少年维持治疗的安全性和耐受性；https://www.clinicaltrials.gov/study/NCT03238326?cond=NCT03238326
