| CTRI Number |
CTRI/2020/11/028899 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial study to compare antidepressants in mild to moderate depression in person with epilepsy(PWE) |
|
Scientific Title of Study
|
A randomized controlled study to compare antidepressants in mild to moderate depression in person with epilepsy (PWE) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjari Tripathi |
| Designation |
Professor, Department of Neurology |
| Affiliation |
Affiliation All India Institute of Medical Sciences, New Delhi |
| Address |
Room No 705, Neurosciences Centre ALL INDIA INSTITUTE OF MEDICAL SCIENCES
South West
DELHI
110029 India
South West
DELHI
110029
India |
| Phone |
01126594494 |
| Fax |
|
| Email |
manjari.tripathi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjari Tripathi |
| Designation |
Professor, Department of Neurology |
| Affiliation |
Affiliation All India Institute of Medical Sciences, New Delhi |
| Address |
Room No 705, Neurosciences Centre ALL INDIA INSTITUTE OF MEDICAL SCIENCES
South West
DELHI
110029 India
South West
DELHI
110029
India |
| Phone |
01126594494 |
| Fax |
|
| Email |
manjari.tripathi1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant bhatele |
| Designation |
Senior Resident, Department of Neurology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
NS 5, Neurosciences Centre ALL INDIA INSTITUTE OF MEDICAL SCIENCES
South West
DELHI
110029 India
South West
DELHI
110029
India |
| Phone |
6397885316 |
| Fax |
|
| Email |
prshntbhatele@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Manjari Tripathi |
| Address |
Room No 705, Neurosciences Centre ALL INDIA INSTITUTE OF MEDICAL SCIENCES
South West
DELHI
110029 India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjari Tripathi |
All India Institute of Medical science,New Delhi |
Room No 705, Neurosciences Centre, Department of Neurology
South West
DELHI |
01126594494
manjari.tripathi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research,AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G40||Epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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)
|
| Comparator Agent |
Venlafaxine |
Venlafaxine 37.5mg/day for 1 week then 75 mg/day for 3 weeks followed by 150 mg/day for 4 weeks in non responders (responders will continue 75mg/day for next 4 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age >18years
2. Patients with generalized and focal epilepsy on antiseizure medications(ASM)
3. Patients eligible using 21 item Hamilton’s depression rating scale.
|
|
| ExclusionCriteria |
| Details |
1. Patients who scored severe and very severe depression score on Hamilton’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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ✔ 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
|
| Outcome |
TimePoints |
✔ 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.
✔ To assess quality of life, adherence with antidepressants in PWE at 8 weeks follow up
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 up​. Patient: Person with epilepsy with mild to moderate depression Intervention: Escitalopram Comparison: Venlafaxine Outcome : 21 item HAMD scale Time Period : 8 weeks
|