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A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder.
J Clin Psychiatry. 2013 Aug; 74(8):e772-80.JC

Abstract

OBJECTIVE

To examine the short-term efficacy and tolerability of aripiprazole for children and adolescents with Tourette's disorder.

METHOD

This 10-week multicenter, double-blind, randomized, placebo-controlled trial was conducted from August 2008 to April 2010. Children and adolescents (aged 6-18 years) with a DSM-IV diagnosis of Tourette's disorder and a Yale Global Tic Severity Scale total tic score of 22 or more were randomly assigned (1:1 ratio) to placebo or aripiprazole. The primary outcome measure was mean change from baseline in the total tic score on the Yale Global Tic Severity Scale (last observation carried forward). Assessments of safety and tolerability included spontaneously reported adverse events, extrapyramidal symptoms, serum prolactin level, metabolic variables, and other laboratory evaluations.

RESULTS

Of 61 subjects, 89% completed the study. Patients who received aripiprazole demonstrated a significant reduction from baseline to end of study on the mean (SD) total tic score of the Yale Global Tic Severity Scale compared to those who received placebo (-15.0 [8.4] and -9.6 [8.8], respectively, P=.0196). Response rate on the Tourette's Syndrome Clinical Global Impression-Improvement was 66% and 45% in the aripiprazole and placebo groups, respectively. Mean decrease in the Tourette's Syndrome Clinical Global Impression-Severity of Illness score was significantly different between the groups (P=.0321). In general, aripiprazole was well tolerated and there were no early discontinuations due to adverse events. The incidence of treatment-emergent adverse events between the groups was not significantly different (P=.7550). While aripiprazole decreased serum prolactin concentration (P<.0001), it increased mean body weight, body mass index, and waist circumference significantly (P=.0055, P=.0142, and P=.0270, respectively).

CONCLUSIONS

In comparison with placebo, aripiprazole was efficacious, generally tolerated and safe in the short-term treatment of children and adolescents with Tourette's disorder.

TRIAL REGISTRATION

ClinicalTrials.gov identifier:NCT00706589.

Authors+Show Affiliations

Seoul Brain Research Institute.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24021518

Citation

Yoo, Hanik K., et al. "A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Aripiprazole in Children and Adolescents With Tourette's Disorder." The Journal of Clinical Psychiatry, vol. 74, no. 8, 2013, pp. e772-80.
Yoo HK, Joung YS, Lee JS, et al. A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. J Clin Psychiatry. 2013;74(8):e772-80.
Yoo, H. K., Joung, Y. S., Lee, J. S., Song, D. H., Lee, Y. S., Kim, J. W., Kim, B. N., & Cho, S. C. (2013). A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. The Journal of Clinical Psychiatry, 74(8), e772-80. https://doi.org/10.4088/JCP.12m08189
Yoo HK, et al. A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Aripiprazole in Children and Adolescents With Tourette's Disorder. J Clin Psychiatry. 2013;74(8):e772-80. PubMed PMID: 24021518.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. AU - Yoo,Hanik K, AU - Joung,Yoo Sook, AU - Lee,Jeong-Seop, AU - Song,Dong Ho, AU - Lee,Young Sik, AU - Kim,Jae-Won, AU - Kim,Bung-Nyun, AU - Cho,Soo Churl, PY - 2012/09/24/received PY - 2013/03/22/accepted PY - 2013/9/12/entrez PY - 2013/9/12/pubmed PY - 2013/10/30/medline SP - e772 EP - 80 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 74 IS - 8 N2 - OBJECTIVE: To examine the short-term efficacy and tolerability of aripiprazole for children and adolescents with Tourette's disorder. METHOD: This 10-week multicenter, double-blind, randomized, placebo-controlled trial was conducted from August 2008 to April 2010. Children and adolescents (aged 6-18 years) with a DSM-IV diagnosis of Tourette's disorder and a Yale Global Tic Severity Scale total tic score of 22 or more were randomly assigned (1:1 ratio) to placebo or aripiprazole. The primary outcome measure was mean change from baseline in the total tic score on the Yale Global Tic Severity Scale (last observation carried forward). Assessments of safety and tolerability included spontaneously reported adverse events, extrapyramidal symptoms, serum prolactin level, metabolic variables, and other laboratory evaluations. RESULTS: Of 61 subjects, 89% completed the study. Patients who received aripiprazole demonstrated a significant reduction from baseline to end of study on the mean (SD) total tic score of the Yale Global Tic Severity Scale compared to those who received placebo (-15.0 [8.4] and -9.6 [8.8], respectively, P=.0196). Response rate on the Tourette's Syndrome Clinical Global Impression-Improvement was 66% and 45% in the aripiprazole and placebo groups, respectively. Mean decrease in the Tourette's Syndrome Clinical Global Impression-Severity of Illness score was significantly different between the groups (P=.0321). In general, aripiprazole was well tolerated and there were no early discontinuations due to adverse events. The incidence of treatment-emergent adverse events between the groups was not significantly different (P=.7550). While aripiprazole decreased serum prolactin concentration (P<.0001), it increased mean body weight, body mass index, and waist circumference significantly (P=.0055, P=.0142, and P=.0270, respectively). CONCLUSIONS: In comparison with placebo, aripiprazole was efficacious, generally tolerated and safe in the short-term treatment of children and adolescents with Tourette's disorder. TRIAL REGISTRATION: ClinicalTrials.gov identifier:NCT00706589. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/24021518/A_multicenter_randomized_double_blind_placebo_controlled_study_of_aripiprazole_in_children_and_adolescents_with_Tourette's_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2013/v74n08/v74n0805.aspx DB - PRIME DP - Unbound Medicine ER -