| CTRI Number |
CTRI/2024/07/069806 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study Memantine as an add-on drug to Escitalopram for Geriatric depression: A double-blind trial |
|
Scientific Title of Study
|
To study Memantine as an add-on drug to Escitalopram for Geriatric depression: A double-blind trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navkiran S Mahajan |
| Designation |
Professor and Head Department of Psychiatry |
| Affiliation |
Dayanand Medical college and hospital |
| Address |
Department of Psychiatry Dayanand Medical College and Hospital Civil Lines Ludhiana Punjab 141001 India
Ludhiana
PUNJAB
141001
India |
| Phone |
9872655008 |
| Fax |
|
| Email |
drnavkiran@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakshanda |
| Designation |
PG resident Department of Psychiatry |
| Affiliation |
Dayanand Medical college and hospital |
| Address |
Department of Psychiatry Dayanand Medical College and Hospital Tagore nagar Civil lines Ludhiana Punjab 141001 India
Ludhiana
PUNJAB
141001
India |
| Phone |
7307908360 |
| Fax |
|
| Email |
dr.rakshandavashisht@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navkiran S Mahajan |
| Designation |
Professor and Head Department of Psychiatry |
| Affiliation |
Dayanand Medical college and hospital |
| Address |
Department of Psychiatry Dayanand Medical College and Hospital Civil Lines Tagore nagar Ludhiana Punjab 141001 India
Ludhiana
PUNJAB
141001
India |
| Phone |
9872655008 |
| Fax |
|
| Email |
drnavkiran@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical college and hospital,Civil lines, Tagore Nagar, Ludhiana, Punjab ,141001, India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical college and hospital |
| Address |
Department of Psychiatry Dayanand Medical College and Hospital Civil Lines Ludhiana Punjab 141001 India |
| Type of Sponsor |
Private medical college |
|
|
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 Navkiran S Mahajan |
Dayanand Medical college and Hospital |
Department of Psychiatry, Dayanand Medical college and hospital,Civil lines,Tagore Nagar,141001
Ludhiana
PUNJAB |
9872655008
drnavkiran@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee, Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Memantine |
The patients currently on Escitalopram 10-20 mg/day will be randomly allocated into 2 groups of 30 each receiving either Memantine 10 mg or the placebo |
| Comparator Agent |
Placebo |
The patients currently on Escitalopram 10-20 mg/day will be randomly allocated into 2 groups of 30 each receiving either Memantine 10 mg or the placebo |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.The patients with a diagnosis of Major depressive disorder according to DSM-5 criteria presenting to Department of Psychiatry,DMC&H, Ludhiana
2.Age group 60-99 years
3.Score of more than or equal to 16 on the 24-item Hamilton Rating Scale for Depression (HAM-D)
4.Score of more than 5 on Geriatric Depression Scale
5.Patients who have given consent for the study |
|
| ExclusionCriteria |
| Details |
1.History of any other major psychiatric disorder
2.Recent or current unstable medical or neurological disorder
3.Diagnosis of moderate/severe cognitive impairment and patients with dementia (Dementia screening by Clinical Dementia Rating Score of 0.5)
4.Known allergic reaction to Escitalopram or Memantine
5.Patients who have not given consent for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be assessed on Hamilton Depression Rating Scale (HAM-D) and GDS-15. |
Depressed mood and neurocognitive function will be judged in the beginning,3 weeks and at the end of the study and the scores will be compared. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neurocognitive function assessment |
Neurocognitive function will be judged in the beginning,3 weeks and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Geriatric depression significantly decreases the quality of life and affects 10-15% of individuals. Co-morbid cognitive impairment in late-life depression is prevalent and disabling. Hence treatment strategies targeting depression and neurocognitive deficits in older adults are needed. This study aims to study the efficacy of administration of Memantine as an add on to Escitalopram compared with placebo and Escitalopram for improving mood and cognitive function in older function in older adults with Major depression and mild cognitive impairment. The study is a randomized double-blinded placebo-controlled trial, conducted on 60 patients with age more than 60 years diagnosed as Major depressive disorder, currently receiving Escitalopram 10-20 mg/day, presenting to Department of Psychiatry, DMC&H, Ludhiana. The patients will be randomly allocated into 2 groups of 30 each receiving either Memantine 10 mg or the placebo for 6 weeks. Evaluation will be done using Hamilton Depression Rating Scale (HAM-D), Geriatric Depression Scale (GDS) and neurocognitive tests. Patients will be assessed at 0,3 and 6 weeks, scores will be compared. The present study will draw attention to the fact that use of cognitive enhancers along with antidepressant therapy in older adults with major depression significantly improves mood and cognitive function. |