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
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Full-scale intelligence quotient
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 10.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adolescents with mild and moderate intellectual disability (full-scale IQ between 35 and 70).
Exclusion Criteria
- •Already receiving any stimulant or non-stimulant medication for hyperactivity (atomoxetine, methylphenidate, clonidine) or any typical or atypical antipsychotic Suffering from uncontrolled epilepsy (seizure within one month before enrolment) or receiving any medication for seizures, movement disorder or spasticity Severe hearing or vision impairment, which impairs accurate interpretation of subtests employed in MISIC Chronic cardiac, pulmonary, renal, hepatic or gastrointestinal illness Already receiving modafinil or have received modafinil previously Satisfying DSM-5 criteria for autism spectrum disorder Parents or adolescents not giving informed consent.
Outcomes
Primary Outcomes
Full-scale intelligence quotient
Time Frame: At 0 and 12 weeks
Secondary Outcomes
- Vanderbilt ADHD Diagnostic Parent Rating Scale(At 0 and 12 weeks)
- Adolescent Sleep Hygiene Scale score(At 0 and 12 weeks)
Investigators
Dr Prateek Kumar Panda
AIIMS, Rishikesh