| CTRI Number |
CTRI/2025/03/082605 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| 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 to assess the effectiveness of ketamine when used with antidepressants in moderate to severe depressive episode |
|
Scientific Title of Study
|
Ketamine as an adjuvant to antidepressants in moderate to severe unipolar depression: A randomised clinical 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 Shruthi Nandakumar |
| Designation |
Postgraduate student |
| Affiliation |
Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU) |
| Address |
Department of Psychiatry,
Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU),Bangaramma Sajjan Campus,
Vijayapura-586103,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
8606331101 |
| Fax |
|
| Email |
shru.22nk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Ramdurg |
| Designation |
Professor and HOD |
| Affiliation |
Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU) |
| Address |
Department of Psychiatry,
Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU),Bangaramma Sajjan Campus,
Vijayapura-586103,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9611281386 |
| Fax |
|
| Email |
santoshramdurg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRUTHI NANDAKUMAR |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
SHRI BM PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, BLDE(DU) |
| Address |
DEPARTMENT OF PSYCHIATRY,
SHRI BM PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, BLDE(DU),BANGARAMMA SAJJAN CAMPUS,
VIJAYAPURA-586103,
KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
8606331101 |
| Fax |
|
| Email |
shru.22nk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU),Bangaramma Sajjan Campus,
Vijayapura-586103,
Karnataka
|
|
|
Primary Sponsor
|
| Name |
Dr Shruthi Nandakumar |
| Address |
Junior Resident, Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU),Bangaramma Sajjan Campus,
Vijayapura-586103,
Karnataka
|
| 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 Shruthi Nandakumar |
Shri BM Patil Medical College, Hospital and Research Centre |
OPD 19, Department of Psychiatry,
BLDE(DU), Bangaramma Sajjan Campus, Solapur Road,
Vijayapura - 586103, Karnataka State, India
Bijapur
KARNATAKA |
8606331101
shru.22nk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F32||Major depressive disorder, singleepisode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV ketamine infusion along with oral antidepressants |
0.5 mg/kg of ketamine is diluted in 100ml normal saline and given over a period of 40 minutes. Total 4 cycles of ketamine infusion will be given, with 2 cycles given per week. |
| Comparator Agent |
ORAL ANTIDEPRESSANTS |
One group of patients will be receiving only oral antidepressants for a duration of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients in the age group of 18 to 65 years
Subjects who agree to sign an informed consent document
Subjects diagnosed with moderate or severe depression by a qualified psychiatrist
according to ICD 10 or ICD 11
Subjects having an initial score of more than 20 on the Montgomery Asberg Depression Rating
Scale
Subjects with or without history of suicide attempts in current episode
Subjects with or without co-morbid anxiety, panic or obsessive compulsive symptoms |
|
| ExclusionCriteria |
| Details |
Subjects of age more than 65 years
Subjects with history of bipolar depression
Subjects with psychotic symptoms
Subjects with pre-existing cognitive impairment or mental retardation
Subjects with history of hypersensitivity to ketamine
Pregnant and breastfeeding women
Subjects with history of substance use (except nicotine and/or caffeine) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the onset of response and effectiveness of ketamine as an adjuvant to oral antidepressants
in moderate to severe unipolar depression. |
Baseline, after 24 hours, 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess improvement in symptoms using Montgomery Asberg Depression Rating
Scale (MADRS) scores in both study groups. |
Baseline, after 24 hours, 2 weeks & 4 weeks |
To assess the risk of suicidal intent using Columbia- Suicide Severity Rating Scale
(C-SSRS) & response to treatment in both study groups.
|
Baseline, after 24 hours, 2 weeks & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Major Depressive Disorder (MDD) is a severe condition affecting millions globally, leading to significant health and socioeconomic burdens. Conventional antidepressants and cognitive-behavioral therapies often have delayed effects and may not work for all patients. This delay is particularly problematic for those at risk of suicide. Ketamine, an NMDA-receptor antagonist, has shown rapid antidepressant effects at low doses, offering a potential breakthrough for faster relief in MDD treatment, especially in individuals with suicidal thoughts. However, there is limited research on its use alongside standard antidepressants in real-world clinical settings. The study aims to evaluate the effectiveness and onset of response of ketamine as an adjuvant therapy to oral antidepressants in moderate to severe unipolar depression. Key assessments include: 1) Depression symptom improvement (using the Montgomery-Åsberg Depression Rating Scale - MADRS)
2) Suicidal intent assessment (using the Columbia-Suicide Severity Rating Scale - C-SSRS)
Sample size: 70 participants (35 per group)
Design: Both groups will receive oral antidepressants, along with one group also receiveing IV ketamine therapy (4 cycles over 4 weeks, with 2 cycles per week).
Application of scales at 1st visit, after 24 hours, after 2 weeks and 4 weeks. |