The evaluation of effectiveness of Adjunctive use of sertraline on seizure improvement in patients with drug-resistant temporal lobe epilepsy

Phase 2

Conditions: Temporal lobe epilepsy.
Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable
G40.01

Registration Number: IRCT20200517047483N1

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures