Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: Modafinil: oral 100 mg one tablet once daily for one week and then one tablet twice daily for next 11 weeks
Control Intervention1: Placebo: One tablet once daily for one week and then o
Sponsors
Department of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: Adolescents with mild and moderate intellectual disability (full-scale IQ between 35 and 70)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Full-scale intelligence quotientTimepoint: At 0 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Vanderbilt ADHD Diagnostic Parent Rating ScaleTimepoint: At 0 and 12 weeks;Adolescent Sleep Hygiene Scale scoreTimepoint: At 0 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Prateek Kumar Panda
AIIMS, Rishikesh
Outcome results
None listed