Effects of Piracetam as an Adjuvant Therapy on Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

Background: Stimulants are highly effective in controlling symptoms of Attention-deficit/hyperactivity disorder (ADHD), but 30% of individuals with ADHD do not respond to them or cannot tolerate their side effects; thus, alternative treatment approaches need to be considered. Objectives: To evaluate the effect and safety of piracetam as an adjuvant therapy plus methylphenidate (MPH) in children with ADHD. Methods: Thirty-six children with ADHD (6-16 years old), admitted to three academic outpatient child psychiatric clinics in the second half of 2015, were randomly assigned to the "methylphenidate plus piracetam group" and the "methylphenidate plus placebo" group, in a double-blind, placebo-controlled study, for 6 weeks. The "Conner's Parents' Rating Scale-Revised (CPRS-R), Children Symptom Inventory-4 (CSI-4), Clinical Global Impression-Improvement scale (CGI-I), and Children' Global Assessment Scale (CGAS) were completed at baseline and at the ends of the third and the sixth week, and the New York State Psychiatric Institute side effect forms were completed weekly, as outcome measures. Results: The level of improvement in CPRS-R, CSI-4, and CGI-I scales were significantly higher in the "methylphenidate plus piracetam" group compared with the "methylphenidate plus placebo" group. Side effects were not remarkable in any group. Conclusions: Piracetam as a short-term adjuvant treatment to methylphenidate can have considerable therapeutic effect and safety profile in children with ADHD and deserves further exploration to assess its potentialities in ADHD treatment.