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

A randomized controlled study to compare antidepressants in mild to moderate depression in person with epilepsy (PWE)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028899
Enrollment
90
Registered
2020-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G40- Epilepsy and recurrent seizures

Interventions

Intervention1: Escitalopram: Escitalopram 5mg/day for 1 week then 10mg/day for 3 weeks followed by 20mg/day for 4 weeks in non responders (responders will continue 10mg/day for next 4 weeks) Contro

Sponsors

Dr Manjari Tripathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18years 2. Patients with generalized and focal epilepsy on antiseizure medications(ASM) 3. Patients eligible using 21 item Hamiltonââ?¬•s depression rating scale.

Exclusion criteria

Exclusion criteria: 1. Patients who scored severe and very severe depression score on Hamiltonââ?¬•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

Design outcomes

Primary

MeasureTime frame
âÅ?â? To study the difference in efficacy and adverse event profile of antidepressants in mild to moderate depression in PWE at 8 weeks follow up.Timepoint: 8 weeks

Secondary

MeasureTime frame
âÅ?â? 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. âÅ?â? To assess quality of life, adherence with antidepressants in PWE at 8 weeks follow up Timepoint: 8 weeks

Countries

India

Contacts

Public ContactPrashant bhatele

Affiliation All India Institute of Medical Sciences, New Delhi

manjari.tripathi1@gmail.com01126594494

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026