Extended-Release Guanfacine Does Not Show a Large Effect on Tic Severity in Children with Chronic Tic Disorders.

Abstract

OBJECTIVE:

To evaluate the tolerability, safety, and preliminary efficacy of extended-release guanfacine in children with chronic tic disorders, including Tourette's disorder (collectively referred to as CTD).

METHODS:

This was a multisite, 8-week, randomized, double-blind, placebo-controlled trial. The primary outcome measure was the Yale Global Tic Severity Scale (YGTSS) total score. Key secondary outcomes included the Improvement item of Clinical Global Impressions-Improvement (CGI-I) scale and the Tic Symptom Self-report (TSSR). Adverse events were monitored at each visit.

RESULTS:

Thirty-four subjects (23 boys and 11 girls) of ages 6 to 17 years (mean = 11.1 ± 3.1) with CTD were randomly assigned to extended-release guanfacine (n = 16) or placebo (n = 18). At baseline, the mean YGTSS total score was 26.3 ± 6.6 for the guanfacine group versus 27.7 ± 8.7 for the placebo group. Within the guanfacine group (mean final daily dose of 2.6 ± 1.1 mg, n = 14), the mean YGTSS total score declined to 23.6 ± 6.42 [t(15) = 1.84, p = 0.08; effect size = 0.35]. The results were similar in the placebo group with a score of 24.7 ± 10.54 at week 8 [t(17) = 1.83, p = 0.08; effect size = 0.38]. There was no significant difference in the rate of positive response on the CGI-I between the guanfacine group and placebo (19% [3/16] vs. 22% [4/18], p = 1.0). The most common adverse events were fatigue, drowsiness, dry mouth, headache, and irritability. Two subjects in the guanfacine group discontinued early-one because of an adverse event (depressed mood) and one because of lack of efficacy; two subjects in the placebo group discontinued because of lack of efficacy.

CONCLUSIONS:

This pilot study did not confirm a clinically meaningful effect size within the guanfacine group. These results do not support the launch of a larger efficacy trial for tics in children and adolescents with CTD.

• Authors: Tanya K Murphy, Thomas V Fernandez, Barbara J Coffey, Omar Rahman, Allison Gavaletz, Camille E Hanks, Caitlin S Tillberg, Laura Ibanez Gomez, Denis G Sukhodolsky, Lily Katsovich, Lawrence Scahill
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 27 Issue 9 Pg. 762-770 (Nov 2017) ISSN: 1557-8992 [Electronic] United States
• PMID: 28723227 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Adrenergic alpha-2 Receptor Agonists
• Guanfacine

Topics

• Adolescent
• Adrenergic alpha-2 Receptor Agonists (therapeutic use)
• Child
• Double-Blind Method
• Female
• Guanfacine (therapeutic use)
• Humans
• Male
• Psychiatric Status Rating Scales
• Severity of Illness Index
• Tic Disorders (drug therapy)
• Treatment Outcome