Effect of Methylphenidate and Folic Acid on ADHD Symptoms and Quality of Life and Aggression: A Randomized Double Blind Placebo Controlled Clinical Trial

OBJECTIVE: This clinical trial examines the effect of augmentation of methylphenidate (MPH) with folic acid to improve quality of life, and to treat aggression and ADHD symptoms. METHOD: Participants of this eight week randomized double blind placebo controlled clinical trial were 49 children with ADHD. They were randomly assigned into one of the two groups: the first group receiving methylphenidate (10 to 20mg/day) plus folic (5mg/day), and the second group receiving methylphenidate plus placebo. Parent-reported ADHD symptoms and Overt Aggression Scale score were the outcome measures. Quality of life was assessed as well. Assessments were performed at pre-intervention, and at one month and two months after starting the interventions using repeated measure analysis. RESULTS: The mean age of children was 9.6(2.7) years. Age and gender were not associated with the groups. ADHD symptoms significantly decreased in both groups during the trial. However, no difference was observed between the groups. Moreover, aggression non-significantly decreased in both groups. Meanwhile, there was no difference between the two groups in efficacy for treating different types of aggressive behaviors including: verbal aggression, physical aggression against people, physical aggression against properties or objects, and aggression against self (self-injurious behavior). While methylphenidate improved quality of life of children with ADHD, folic acid did not improve it more than placebo. Both medications were well tolerated. CONCLUSION: considering the marked limitations of this trial, this primarily report suggests that methylphenidate may improve ADHD symptoms and the quality of life of children with ADHD. Current evidence does not support that folic acid as an adjuvant is effective for treating ADHD symptoms or aggression, or the improving quality of life of children with ADHD.