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IRCT20200517047483N1 IRCT 2020-08-21 Shiraz University of Medical Sciences The evaluation of effectiveness of Adjunctive use of sertraline on seizure improvement in patients with drug-resistant temporal lobe epilepsy monoamine oxidase inhibitors (MAOIs); antiepileptic drugs(AEDs); Beck Depression inventory (BDI); Beck Anxiety inventory (BAI) The evaluation of effectiveness of Adjunctive use of sertraline on seizure improvement in patients with drug-resistant temporal lobe epilepsy 2022-09-30 anticipated 30 Complete https://irct.ir/trial/48257 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This is an open-label pilot study. 2 Temporal lobe epilepsy. 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, Titanium Dioxyl (Titanium dioxyl). In the second visit (8 week baseline), all eligible patients receive oral Sertraline as 25 mg on a daily from day 1 to 7 (titration period), and then 50 mg daily from day 8-63, and finally, 50 twice per day for the rest of the study period. How to use: The drug should be taken every day at certain times, with or without food. The drug should be taken with some water and not chewed or crushed tablets.. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD are to be shared When: Starting 6 months after publication To whom: People working in academic institutions Conditions: To help further research to improve the treatment of refractory temporal lobe epilepsy Where to obtain: Mahtab Rostamihosseinkhani mahtabrostami85@yahoo.com How to obtain: Send their request to the mentioned email address and within one working week, if there is no problem, the data will be sent to them. Comments:
public Mahtab Rostamihosseinkhani
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5840 Mahtabrostami85@yahoo.com Shiraz University of Medical Sciences scientific Mahtab Rostamihosseinkhani
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5840 Mahtabrostami85@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 G40.01 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable Treatment - Drugs 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, Titanium Dioxyl (Titanium dioxyl). In the second visit (8 week baseline), all eligible patients receive oral Sertraline as 25 mg on a daily from day 1 to 7 (titration period), and then 50 mg daily from day 8-63, and finally, 50 twice per day for the rest of the study period. How to use: The drug should be taken every day at certain times, with or without food. The drug should be taken with some water and not chewed or crushed tablets. 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. Shiraz University of Medical Sciences Approved 2020-01-21 Medical Sciences Review Board and Ethics Committee (IRCT ) Namazi Sq., Zand St. Shiraz Fars Iran (Islamic Republic of)