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Randomized, double-blind, placebo-controlled trial of aripiprazole oral solution in children and adolescents with Tourette's disorder.
He, Fan; Luo, Jie; Huang, Yi; Hao, Yunpeng; Sun, Ling; Ke, Xiaoyan; Wu, Bin; Chen, Yucai; Han, Ying; Zhang, Yuebing; Liu, Jing; Han, Hong; Xian, Mingji; Uki, Motomichi; Zheng, Yi.
Afiliación
  • He F; Beijing Anding Hospital, Capital Medical University, Beijing, China.
  • Luo J; Beijing Anding Hospital, Capital Medical University, Beijing, China.
  • Huang Y; West China Hospital, Sichuan University, Chengdu, China.
  • Hao Y; The First Hospital of Jilin University, Changchun, China.
  • Sun L; Tianjin Mental Health Centre, Tianjin Anding Hospital, Tianjin, China.
  • Ke X; Nanjing Brain Hospital, Nanjing, China.
  • Wu B; Xi'an Mental Health Center, Xi'an, China.
  • Chen Y; Shanghai Children's Hospital, Shanghai, China.
  • Han Y; Peking University First Hospital, Beijing, China.
  • Zhang Y; Shandong Daizhuang Hospital, Jining, China.
  • Liu J; Peking University Sixth Hospital, Beijing, China.
  • Han H; Shanxi Children's Hospital, Taiyuan, China.
  • Xian M; Otsuka Beijing Research Institute, Beijing, China.
  • Uki M; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
  • Zheng Y; Beijing Anding Hospital, Capital Medical University, Beijing, China. yizheng@ccmu.edu.cn.
Child Adolesc Psychiatry Ment Health ; 18(1): 88, 2024 Jul 18.
Article en En | MEDLINE | ID: mdl-39026306
ABSTRACT

BACKGROUND:

Aripiprazole is the most frequently recommended antipsychotic for the treatment of tics in children and adolescents with Tourette's disorder (TD). However, to date, a randomized controlled trial for aripiprazole oral solution has not been conducted despite being widely preferred by children. Therefore, we examined whether aripiprazole oral solution is effective for treating tics.

METHODS:

All patients received a flexible dose of aripiprazole oral solution (1 mg/mL, range 2-20 mg) with a starting dose of 2 mg. The target dose for patients weighing < 50 kg was 2, 5, and 10 mg/day, and that for patients weighing ≥ 50 kg was 5, 10, 15, and 20 mg/day. The primary efficacy endpoint was the mean change in the Yale Global Tic Severity Scale-total tic score (YGTSS-TTS) from baseline to week 8.

RESULTS:

Of the 121 patients enrolled, 59 patients (96.7%) in the aripiprazole group and 53 patients (88.3%) in the placebo group completed the study. The aripiprazole group showed significantly greater improvement in the YGTSS-TTS from baseline to week 8 than the placebo group (least squares mean difference [95% confidence interval (CI)] -5.5 [95% CI - 8.4 to - 2.6]). At week 8, the response rate (i.e., percentage of patients with a Tourette's Syndrome Clinical Global Impression-Improvement score of 1 or 2) of the aripiprazole group (86.4%) was significantly higher than that of the placebo group (56.6%; odds ratio 3.6, p < 0.001). The incidence of treatment-emergent adverse events (TEAEs) reported in at least one patient was 86.9% in the aripiprazole group and 65.5% in the placebo group. All TEAEs were mild or moderate in severity. No serious adverse events or deaths occurred during the study.

CONCLUSIONS:

Our findings suggest that aripiprazole oral solution is an effective, well-tolerated, and safe treatment for children and adolescents with TD. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03487783. Registered 4 April 2018.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Child Adolesc Psychiatry Ment Health Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Child Adolesc Psychiatry Ment Health Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido