Efficacy evaluation of omega-3 and risperidone in children with attention-deficit/hyperactivity disorder (ADHD) and refractory epilepsy

Clinical trial of efficacy evaluation of omega-3 capsule with risperidone and risperidone alone on improvement of hyperactivity and inattention symptoms and decrease of monthly frequency of seizure of children with attention-deficit/hyperactivity disorder (ADHD) and refractory epilepsy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201604212639N18

Enrollment

Registered

2016-06-02

Start date

2015-06-29

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory epilesy and attention-deficit/hyperactivity disorder (ADHD). Disturbance of activity and attention

Interventions

Intervention 1: One daily capsule of omega-3 from 21st Century Co, USA and risperidone tablet of 1mg from Abidi Co, Iran divided into two 0.5 mg doses with previous antiepileptic drugs. Intervention 2

Treatment - Drugs

One daily capsule of omega-3 from 21st Century Co, USA and risperidone tablet of 1mg from Abidi Co, Iran divided into two 0.5 mg doses with previous antiepileptic drugs

Risperidone tablet of 1mg from Abidi Co, Iran divided into two 0.5 mg doses with previous antiepileptic drugs

Eligibility

Sex/Gender

All

Age

7 Years to 11 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Razieh Fallah

Shahid Sadoughi University of Medical Sciences, Yazd, Iran

dr.raziehfallah@yahoo.com+98 35 3822 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026