Temporal lobe epilepsy. Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable
Conditions
Interventions
Intervention group:the patient with drug-resistant temporal lobe epilepsy. Drug name: Sertraline
Brand: Asentra
Manufactured by: Actoverco under license Krka
Ingredients: Each coated tablet contains 50 mg or 100 mg of Sertraline Hydrochloride
other ingredients: Calcium Hydrogen Phosphate Dihydrate, Sodium Starch Glycolate, Microcrystalline Cellulose, Hydroxypropyl Cellulose, Talc, Magnesium Stearate, Hydroxypropyl Methyl cellulose, Titaniu
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male / female (non-pregnant female adequately protected from conception) patients, between ages 18 and 65 years Patients with diagnosis of temporal lobe epilepsy The patient made on the basis of clinical findings with drug-resistant seizures defined as failure of two or more AEDs at maximal tolerated doses and one or more seizures per month The patients have stable medication regimen for four weeks prior to entry
Exclusion criteria
Exclusion criteria: Patients with progressive neurological conditions Patients with a history of non adherence for seizure diary completion or frequent clinic visits Patients with a history of having any serious medical illness or major psychiatric disorder, History of psychogenic nonepileptic seizures History of suicidal attempt in the past five years any known Pracense of contraindication for sertraline administration including: concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) and hypersensitivity to sertraline Taking any other medication with significant drug interaction with sertraline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of Sertraline on reducing of seizure count in patients with drug-resistant temporal lobe epilepsy. Timepoint: Before starting the study, 9th & 18th weeks of study, at the end of the study. Method of measurement: History taking.;The effect of Sertraline on reducing of depression rate in patients with drug-resistant temporal lobe epilepsy. Timepoint: Before starting the study, at the end of the study. Method of measurement: Beck Depression Inventory Assessment.;The effect of Sertraline on reducing of anxiety rate in patients with drug-resistant temporal lobe epilepsy. Timepoint: Before starting the study, at the end of the study. Method of measurement: Beck Anxiety Inventory Assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahtab Rostamihosseinkhani
Shiraz University of Medical Sciences
Outcome results
None listed