{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T20:06:22Z","timestamp":1792008382863,"version":"4.4.0"},"reference-count":36,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2017,11,1]],"date-time":"2017-11-01T00:00:00Z","timestamp":1509494400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2017,11,1]],"date-time":"2017-11-01T00:00:00Z","timestamp":1509494400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>Aripiprazole modulates dopaminergic and serotonergic pathways that may play a role in the pathogenesis of Tourette's disorder (TD). This trial evaluated the efficacy and safety of oral aripiprazole in the suppression of tics in children and adolescents with TD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      This phase 3, randomized, double-blind, placebo-controlled trial (\n                      <jats:uri xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:uri>\n                      , NCT01727700) recruited patients who were 7\u201317 years old with a diagnosis of TD from hospitals, private practices, and research clinics at 76 sites in the United States, Canada, Hungary, and Italy. Patients were randomized in a 1:1:1 ratio by using an interactive voice\/web-response system to low-dose aripiprazole (5\u2009mg\/day if &lt;50\u2009kg; 10\u2009mg\/day if \u226550\u2009kg), high-dose aripiprazole (10\u2009mg\/day if &lt;50\u2009kg; 20\u2009mg\/day if \u226550\u2009kg), or placebo for 8 weeks. Randomization was stratified by region (North America or Europe) and baseline body weight (&lt;50\u2009kg vs. \u226550\u2009kg). The primary efficacy endpoint was mean change from baseline to week 8 in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) for the intent-to-treat population.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Between November 2012 and May 2013, 133 patients were recruited and randomized to low-dose aripiprazole (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200944), high-dose aripiprazole (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200945), or placebo (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200944). Least-squares mean treatment differences versus placebo in change from baseline to week 8 in the YGTSS-TTS were statistically significant (high dose, \u22129.9 [95% confidence interval, CI, \u221213.8 to \u22125.9], low dose, \u22126.3 [95% CI, \u221210.2 to \u22122.3]). At week 8, 69% (29\/42) of patients in the low-dose and 74% (26\/35) of patients in the high-dose aripiprazole groups demonstrated a Clinical Global Impression\u2013Tourette's Syndrome improvement score of 1 (very much improved) or 2 (much improved) compared with 38% (16\/42) in the placebo group. The most common adverse events (AEs) were sedation (low dose, 8\/44 [18.2%], high dose, 4\/45 [8.9%], placebo, 1\/44 [2.3%]), somnolence (low dose, 5\/44 [11.4%], high dose, 7\/45 [15.6%], placebo, 1\/44 [2.3%]), and fatigue (low dose, 3\/44 [6.8%], high dose, 7\/45 [15.6%], placebo, 0). No serious AEs or deaths occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This study indicates that oral aripiprazole is a safe and effective treatment for tics in children and adolescents with TD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2016.0026","type":"journal-article","created":{"date-parts":[[2017,7,7]],"date-time":"2017-07-07T16:22:58Z","timestamp":1499444578000},"page":"771-781","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":121,"title":["Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents"],"prefix":"10.1177","volume":"27","author":[{"given":"Floyd","family":"Sallee","sequence":"first","affiliation":[{"name":"University of Cincinnati College of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Kohegyi","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"McQuade","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Cox","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond","family":"Sanchez","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alet","family":"van Beek","sequence":"additional","affiliation":[{"name":"Mylan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaretta","family":"Nyilas","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Carson","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Kurlan","sequence":"additional","affiliation":[{"name":"Atlantic Neuroscience Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,11,1]]},"reference":[{"key":"e_1_3_4_2_1","unstructured":"Abilify\u00ae (aripiprazole): Full Prescribing Information. 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