| CTRI Number |
CTRI/2026/02/104023 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the effectiveness of Escitalopram and Buspirone combination therapy in treating late life depression accompanied by impairment in thinking, reasoning, remembering,and problem solving.
Escitalopram: Used for depressive symptoms
Buspirone: Used for anxiety symptoms and to improve cognition |
|
Scientific Title of Study
|
Assessing the efficacy of combined Escitalopram and Buspirone in late life depression accompanied by cognitive impairment:An open label randomised controlled trail |
| 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 Sayan Kumar Ghosh |
| Designation |
Junior Resident |
| Affiliation |
Aiims, New Delhi |
| Address |
Department of Psychiatry, Aiims New Delhi, Ansari Nagar, New Delhi 110029
North East
DELHI
110029
India |
| Phone |
7005357838 |
| Fax |
|
| Email |
sayankkr239@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Koushik Sinha Deb |
| Designation |
Assistant Professor, Department of Psychiatry |
| Affiliation |
Aiims, New Delhi |
| Address |
Room No: 4096, Department of Psychiatry, Teaching Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-29
North East
DELHI
110029
India |
| Phone |
9868945171 |
| Fax |
|
| Email |
Koushik.sinha.deb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Koushik Sinha Deb |
| Designation |
Assistant Professor, Department of Psychiatry |
| Affiliation |
Aiims, New Delhi |
| Address |
Room No: 4096, Department of Psychiatry, Teaching Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-29
North East
DELHI
110029
India |
| Phone |
9868945171 |
| Fax |
|
| Email |
Koushik.sinha.deb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims New Delhi, Ansari Nagar, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Dr. Sayan Kumar Ghosh |
| Address |
Hostel 12, Aiims New Delhi, Ansari Nagar, New Delhi- 110029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sayan Kumar Ghosh |
Aiims New Delhi |
Department of Psychiatry, Room no.4096, Ansari nagar, New Delhi 110029
East
DELHI |
7005357828
sayankkr239@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aiims, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (4) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Escitalopram |
In the comparator group only Tab. Escitalopram will be started at 5mg and will be built upto 10 mg after 1 week |
| Intervention |
Escitalopram + Buspirone |
In the Intervention group, Tab. Escitalopram will be started at 5mg and will be built upto 10mg after 1 week and Tab. Buspirone will be started at 7.5mg BD and will be built upto 15mg BD after 1 week. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosed with current Depressive episode according to ICD-11 (Single Episode Depressive Disorder / Recurrent Depressive Disorder)
|
|
| ExclusionCriteria |
| Details |
1)Diagnosed with current depressive episode in Bipolar affective disorder according to ICD-11
2)Presence of psychotic symptoms
3)Any contraindication to the use of Escitalopram or Buspirone
4)Any other co-morbid major psychiatric disorder(Except Tobacco dependence)
5)On current treatment for dementia |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of combined Escitalopram (10 mg) and Buspirone (30 mg) vs Escitalopram (10 mg) monotherapy in improving cognition among elderly patients with Depression accompanied by cognitive impairment.
|
Improvement in cognition and depressive symptoms will be measured at baseline, 4 weeks and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare the efficacy of combined Escitalopram (10 mg) and Buspirone (30 mg) vs Escitalopram (10 mg) monotherapy in improving the depressive symptoms among elderly patients with Depression.
2)To compare the side-effect profile and drop-out from treatment in the combined Escitalopram and Buspirone group as compared with Escitalopram monotherapy group. |
4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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="6"
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
|
The thesis titled "Assessing the efficacy of combined Escitalopram and Buspirone in late life depression accompanied by cognitive impairment: An open label randomised controlled trial" explores the therapeutic potential of combining Escitalopram, a selective serotonin reuptake inhibitor(SSRI), with Buspirone, an anxiolytic in treating late life depression that is complicated by cognitive impairment. The research investigates whether this combination offers better outcomes in terms of alleviating depressive symptoms and improving cognitive function compared to Escitalopram monotherapy. The findings aim to provide a deeper understanding of how these medications may work synergistically to address the complex interaction between mood disorders and cognitive decline in older adults. |