Comparison of efficacy of oral modafinil in improving cognition in adolescents with intellectual disability aged 10-18 years: a double-blind, randomized, placebo-controlled trial

This RCT will be a double blind placebo-controlled trial exploring the efficacy of oral modafinil for 12 weeks as compared to a matching placebo in improving full-scale intelligence quotient in adolescents with mild and moderate intellectual disability. Each participant will be randomised to receive either modafinil or a placebo for 12 weeks. Variable block randomisation and allocation concealment by serially numbered sealed opaque envelopes will be used. We will also assess the change in the Vanderbilt ADHD diagnostic parent rating scale and adolescent sleep hygiene scale at 12 weeks as compared to baseline in both groups as secondary objectives.