Autism Research: A Double-Blind, Placebo-Controlled Study of the Efficacy of Transdermal Clonidine in Autism

Clonidine Research:

Efficacy and Safety of Transdermal Clonidine Study in Autistic Children

Research Studies Safety and Efficacy of Clonidine Patch to Treat Autism Behaviors

Research conducted prior to this study had shown that clonidine was effective in treating hyperactivity, impulsivity, and inattention in attention deficit hyperactivity disorder (ADHD).  However, little to no research had been performed to study the effectiveness of clonidine in treating hyperactivity, hypervigilence, self-stimulation, and stereotyped body movements in autism.  This study focused on the safety and efficacy of transdermal clonidine (i.e. a clonidine patch) in treating those behaviors in autism.  The findings were published in an article titled A Double-Blind, Placebo-Controlled Study of the Efficacy of Transdermal Clonidine in Autism.

The study utilized a double-blind, placebo-crossover design.  A total of 9 individuals with autism participated in the study.  Their ages ranged from 5 to 33 years.  The study group received 0.005 mg/kg/day of clonidine via a transdermal patch while the control group received a placebo patch.

The trial consisted of two phases, each lasting 4 weeks.  During phase 1 some of the participants received the clonidine patch while the remaining individuals received placebo.  A 2 week washout period then occurred in which none of the participants received clonidine.  During phase 2 those that had received placebo during phase 1 received clonidine and vice versa.

During each phase the participants were assessed on a weekly basis by parents and every other week by clinicians.

Clonidine Benefits:

The research demonstrated that treatment with clonidine resulted in significant improvements in responses determined by feelings/emotions, sensory responses, and social relationship to people as rated by the Ritvo-Freeman Real Life Rating Scale.  The researchers also reported significant improvements in severity of autism and overall global improvement as rated by the Clinical Global Improvement (CGI).  A global rating scale performed by patients also showed significant improvements with clonidine treatment compared to placebo.

Clonidine Side Effects:

Many patients reported feeling sedated and fatigued during the first 2 weeks of therapy with clonidine.

The researchers state that their findings suggest clonidine may be effective in decreasing hyperactivity, hypervigilence, self-stimulation, and stereotyped body movements in autism.  They also suggest that clonidine may improve social relationships in some individuals with autism.  Finally, they recommend that larger studies utilizing clonidine be conducted to determine the best dosing for optimal response in treating behaviors associated with autism.

The article was published in the Journal of Clinical Psychiatry in March 1992.

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