Efficacy of guanfacine extended release assessed during the morning, afternoon, and evening using a modified Conners' Parent Rating Scale-revised: Short Form.

Abstract

OBJECTIVE:

The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release (GXR) monotherapy administered either in the morning or evening, using a modified Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) assessed three times/day in children with attention-deficit/hyperactivity disorder (ADHD).

METHODS:

This multicenter, double-blind, placebo-controlled study randomized children 6-12 years of age with ADHD into three groups: GXR a.m. (GXR in the morning and placebo in the evening), GXR p.m. (placebo in the morning and GXR in the evening), or twice-daily placebo. The CPRS-R:S, administered in the morning, afternoon, and evening prior to each study visit, was a secondary measure of efficacy.

RESULTS:

A total of 333 subjects were included in the analysis population (GXR a.m., n=107; GXR p.m., n=114; placebo, n=112). At visit 10, last observation carried forward (LOCF), subjects receiving GXR demonstrated significantly greater improvement from baseline in the daily mean CPRS-R:S total score, as well as in each of the morning, afternoon, and evening CPRS-R:S assessments, compared with placebo, regardless of the time of GXR administration (p<0.001 vs. placebo for GXR a.m. and GXR p.m.). In addition, subjects receiving GXR showed significantly greater improvements from baseline in each subscale score (oppositional, cognitive problems/inattention, hyperactivity, and ADHD index) compared with those receiving placebo, regardless of time of administration (p<0.003 vs. placebo across all subscales for GXR a.m. and GXR p.m.).

CONCLUSIONS:

These results provide further support for the demonstrated efficacy of once-daily GXR in reducing ADHD symptoms, and demonstrate that response is consistent throughout the day regardless of the time of administration, with improvement seen in ratings of oppositional as well as of ADHD symptoms.

• Authors: Joel Young, Thomas Rugino, Ryan Dammerman, Andrew Lyne, Jeffrey H Newcorn
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 24 Issue 8 Pg. 435-41 (Oct 2014) ISSN: 1557-8992 [Electronic] United States
• PMID: 25286026 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Delayed-Action Preparations
• Guanfacine

Topics

• Attention Deficit Disorder with Hyperactivity (drug therapy)
• Child
• Delayed-Action Preparations
• Double-Blind Method
• Drug Administration Schedule
• Female
• Guanfacine (adverse effects, therapeutic use)
• Humans
• Male
• Parents
• Severity of Illness Index
• Treatment Outcome