Efficacy evaluation of omega-3 and risperidone in children with attention-deficit/hyperactivity disorder (ADHD) and refractory epilepsy
Phase 2
- Conditions
- Refractory epilesy and attention-deficit/hyperactivity disorder (ADHD).Disturbance of activity and attention
- Registration Number
- IRCT201604212639N18
- Lead Sponsor
- Shahid Sadoughi University of Medical Sciences, Yazd, Iran
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Age range of 7-11 years; having refractory epilepsy based on definition of the International League Against Epilepsy; having ADHD based on DSM-IV criteria; having at least score of 20 in ADHD diagnostic rating scale via parent interview; being able to walk
Exclusion criteria: Receiving of all kinds of supplement within the past two months; other psychiatric disorders; status epilepticus during the research period; allergy to omega-3 capsule or risperidone ; change in antiepileptic drugs regimen ; use of phenobarbital or topiramate ; irregular drugs usage; discontinuation of omega-3 capsule or risperidone usage for more than one week
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monthly frequency of seizures. Timepoint: Before and three months after treatment. Method of measurement: Asking from parents.;ADHD Diagnostic Rating Scale. Timepoint: Before and three months after treatment. Method of measurement: Parent interview.;Parent Conner rating scales. Timepoint: Before and three months after treatment. Method of measurement: Parent interview.
- Secondary Outcome Measures
Name Time Method Efficacy in more than 50% of reduction in monthly frequency of seizure. Timepoint: Three months after treatment. Method of measurement: Asking from parents.;Efficacy in more than 50% of reduction in ADHD diagnostic rating scale. Timepoint: Three months after treatment. Method of measurement: Asking from parents.;Clinical side effects. Timepoint: Monthly until three months after treatment. Method of measurement: Asking from parents.