Effect of pyridoxine on behavioral side effects of levetiracetam
Phase 3
Recruiting
- Conditions
- Epilepsy.Epilepsy and recurrent seizures
- Registration Number
- IRCT20180406039205N1
- Lead Sponsor
- Sari University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Age >=18 years
Patients affected by idiopathic generalized epilepsy
Patients who are treated by levetiracetam (Levebel, Cobel darou) in recent month
Complaint of behavioral problem
Patient's consent for participation
Exclusion Criteria
History of known psychiatric disease
Pregnancy
Incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt
Treatment with psychiatric medications
Alcohol or drug abuse
Mental retardation to the degree that intervenes comprehension and response to questionnaire
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of pyridoxine in treatment of behavioral side effects. Timepoint: before intervention and 3 weeks after intervention. Method of measurement: Symptom checklist-90-revised (SCL-90-R) questionnaire.;Withdrawal rate of levetiracetam due to behavioral side effects. Timepoint: 3 weeks. Method of measurement: Patient interview.
- Secondary Outcome Measures
Name Time Method