التفاصيل البيبلوغرافية
| العنوان: |
A Randomized, Placebo-Controlled Trial of Guanfacine Extended Release in Adolescents With Attention-Deficit/Hyperactivity Disorder. |
| المؤلفون: |
Wilens, Timothy E.1 twilens@partners.org, Robertson, Brigitte2,3, Sikirica, Vanja2,4, Harper, Linda5, Young, Joel L.6, Bloomfield, Ralph2,7, Lyne, Andrew2,8, Rynkowski, Gail2, Cutler, Andrew J.9 |
| المصدر: |
Journal of the American Academy of Child & Adolescent Psychiatry. Nov2015, Vol. 54 Issue 11, p916-925.e2. 1p. |
| مصطلحات موضوعية: |
*ATTENTION-deficit hyperactivity disorder, *CLINICAL trials, *COMPARATIVE studies, *CONTROLLED release preparations, *DOSE-effect relationship in pharmacology, *ANTIHYPERTENSIVE agents, *RESEARCH methodology, *MEDICAL cooperation, *PHENYLPROPANOLAMINE, *PSYCHOLOGICAL tests, *RESEARCH, *STATISTICAL sampling, *SCHOOLS, *EVALUATION research, *RANDOMIZED controlled trials, *TREATMENT effectiveness, *BLIND experiment, *SEVERITY of illness index |
| مصطلحات جغرافية: |
UNITED States |
| مستخلص: |
Objective: Despite the continuity of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known regarding use of nonstimulants to treat ADHD in adolescents. This phase 3 trial evaluated the safety and efficacy of guanfacine extended release (GXR) in adolescents with ADHD.Method: This 13-week, multicenter, randomized, double-blind, placebo-controlled trial evaluated once-daily GXR (1-7 mg per day) in adolescents with ADHD aged 13 to 17 years. The primary endpoint was the change from baseline in the ADHD Rating Scale-IV (ADHD-RS-IV) total score; key secondary endpoints included scores from the Clinical Global Impressions-Severity of Illness (CGI-S), and Learning and School domain and Family domain scores from the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at week 13.Results: A total of 314 participants were randomized (GXR, n = 157; placebo, n = 157). The majority of participants received optimal doses of 3, 4, 5, or 6 mg (30 [22.9%], 26 [19.8%], 27 [20.6%], or 24 [18.3%] participants, respectively), with 46.5% of participants receiving an optimal dose above the currently approved maximum dose limit of 4 mg. Participants receiving GXR showed improvement in ADHD-RS-IV total score compared with placebo (least-squares mean score change, -24.55 [GXR] versus -18.53 [placebo]; effect size, 0.52; p <.001). More participants on GXR also showed significant improvement in CGI-S scores compared with placebo (50.6% versus 36.1%; p = .010). There was no statistically significant difference between treatments at week 13 in the 2 WFIRS-P domains. Most treatment-emergent adverse events were mild to moderate, with sedation-related events reported most commonly.Conclusion: GXR was associated with statistically significant improvements in ADHD symptoms in adolescents. GXR was well tolerated, with no new safety signals reported.Clinical Trial Registration Information: Dose-Optimization in Adolescents Aged 13-17 Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD) Using Extended-Release Guanfacine HCl; http://ClinicalTrials.govTest/; NCT01081132. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
