A clinical trial study to compare antidepressants in mild to moderate depression in person with epilepsy(PWE)

Phase 2

Completed

Conditions: Epilepsy and recurrent seizures,

Registration Number: CTRI/2020/11/028899

Lead Sponsor: Dr Manjari Tripathi

Brief Summary: This study is a randomized, double-blind, parallel active controlled, single-centre trial to compare antidepressants in mild to moderate depression in person with epilepsy(PWE).This study is done to study the difference in efficacy and adverse event profile of antidepressants-Escitalopram and Venlafaxine in mild to moderate depression in person with epilepsy at 8 weeks follow up. This study will also study if adjunctive therapy with antidepressants along with standard antiseizure medications has any effect on seizure frequency in PWE at 8 weeks follow up and assess quality of life and adherence with antidepressants in PWE at 8 weeks follow upâ€‹.

Patient: Person with epilepsy with mild to moderate depression

Intervention: Escitalopram

Comparison: Venlafaxine

Outcome : 21 item HAMD scale

Time Period : 8 weeks

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

1.Age >18years 2.Patients with generalized and focal epilepsy on antiseizure medications(ASM) 3.Patients eligible using 21 item Hamiltonâ€™s depression rating scale.

Exclusion Criteria

1.Patients who scored severe and very severe depression score on Hamiltonâ€™s depression rating scale 2.Psychogenic non-epileptic seizures 3.Any women who want to conceive or pregnant women 4.Unable to give consent 5.Patients having intellectual disability.
6.Any terminal illness such that the patient would not be expected to survive long.
7.Patient with significant non- neurological co-morbidities like chronic cardiac, renal and other systemic diseases that can also causes depression 8.Patients with hepatic disease ,renal disease and with prolonged QTc interval.
9.Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
âœ”To study the difference in efficacy and adverse event profile of antidepressants in mild to moderate depression in PWE at 8 weeks follow up.	8 weeks

Secondary Outcome Measures

Name	Time	Method
âœ”To study if adjunctive therapy with antidepressants along with standard antiseizure medications has any effect on seizure frequency in PWE at 8 weeks follow up.	âœ”To assess quality of life, adherence with antidepressants in PWE at 8 weeks follow up

Trial Locations

Locations (1): All India Institute of Medical science,New Delhi
🇮🇳
West, DELHI, India
All India Institute of Medical science,New Delhi
🇮🇳West, DELHI, India
Dr Manjari Tripathi
Principal investigator
01126594494
manjari.tripathi1@gmail.com