A randomized, placebo-controlled trial of extended-release guanfacine in children with autism spectrum disorder and ADHD symptoms: an analysis of secondary outcome measures

Abstract

In a prior report, we showed that extended-release guanfacine (GEXR) is safe and effective for children with autism spectrum disorder (ASD) accompanied by ADHD symptoms. Here, we examine the impact of GEXR on oppositional behavior, anxiety, repetitive behavior, and sleep disturbance. Sixty-two subjects with ASD (53 boys, 9 girls; ages 5-14 years) were randomly assigned to GEXR (n = 30) or placebo (n = 32) for 8 weeks. Outcomes include the Home Situation Questionnaire-Modified for ASD (HSQ-ASD), Anxiety scale of the Child and Adolescent Symptom Inventory (CASI), Children's Yale-Brown Obsessive-Compulsive Scale-Modified for ASD (CYBOCS-ASD), and Children's Sleep Habits Questionnaire (CSHQ). A repeated measures linear mixed model was used to determine the effects of treatment group and time on HSQ scores. For other measures, change from baseline was evaluated with Analysis of Covariance (ANCOVA).After 8 weeks of treatment, parent ratings of oppositional behavior on the HSQ declined by 44% (per item mean from 3.4 to 1.9) in the GEXR group compared to 12% (from 3.3 to 2.9) for placebo (p = 0.004). Repetitive behavior on the CYBOCS-ASD showed a significantly greater decline in GEXR-treated participants compared to placebo (24% vs. <1%, p = 0.01). No group differences were observed on CASI Anxiety or CSHQ (p = 0.64 and 0.75, respectively). GEXR was effective in reducing oppositional behavior and, more modestly, repetitive behavior. GEXR was not superior to placebo for anxiety, though baseline anxiety ratings were low. GEXR did not significantly improve sleep habits. Future studies could focus on repetitive behavior or anxiety, symptoms with limited treatment options.

Guidance for identification and treatment of individuals with attention deficit/hyperactivity disorder and autism spectrum disorder based upon expert consensus

“…In childhood and adolescence, should psychological/environmental interventions fail, then ADHD medications (stimulant and non-stimulant) are helpful for the characteristic symptoms of inattention, hyperactivity and impulsivity when these are clearly evident (e.g. distinguishing agitation for hyperactivity) and arise from ADHD [131][132][133]. However, in adults with co-occurring ASD and ADHD, medication to treat their ADHD should be offered as appropriate, with regular monitoring, and should not wait until psychological treatment has been completed.…”

Guanfacine’s mechanism of action in treating prefrontal cortical disorders: Successful translation across species

“…nonverbal) cognitive impairment ( Coleman et al, 2019 , Propper, 2018 ). A placebo-controlled study showed that guanfacine could be helpful for reducing oppositional and repetitive behaviors, although social behaviors are usually not improved ( Politte et al, 2018 ).…”

Pharmacological Approaches in Child and Adolescent Mental Health

“…Statistically but not clinically significant response has also been reported for fluoxetine and valproic acid (Hollander et al 2005(Hollander et al , 2010, haloperidol, and clomipramine (Remington et al 2001). Modest improvements of stereotyped behaviors following treatment with guanfacine have been reported (Politte et al 2018).…”