attention deficit hyperactivity disorder. Disturbance of activity and attention
Conditions
Interventions
Intervention 1: Intervention group: methylphenidate 0.3-1 mg/kg/day+ PUFA 430 mg/day,for 10 weeks, dose adjustment based on therapeutic response and side effects. Intervention 2: Control group: Metylp
Treatment - Drugs
Placebo
Intervention group: methylphenidate 0.3-1 mg/kg/day+ PUFA 430 mg/day,for 10 weeks, dose adjustment based on therapeutic response and side effects
Control group: Metylphenidate 0.3-1 mg/kg/day + placebo (producted by the same company which produced PUFA), for 10 weeks, dose adjustment based on therapeutic response and side effects
Sponsors
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1- children with 6-12 years of age, 2- ADHD diagnosis based on DSM-IV-TR, 3- Score of at least 20 in ADHD-RS (parent form). Exclusion criteria: 1- Any major comorbid psychiatric disorder except ODD and LD based on K-SADS, 2- IQ below 70, 3- Use of any psychotropic drug or substance in at least 2 weeks before the study, 4- any major neurological disease, 5- use of PUFA included substances or nutrients more than once a week
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD severity. Timepoint: every 2 weeks. Method of measurement: ADHD-Rating Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug adverse effects. Timepoint: every 2 weeks. Method of measurement: adverse effects questionnair of methylphenidate and PUFA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRozita Davari-Ashtiani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed