| CTRI Number |
CTRI/2025/09/095117 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ketamine for Psychiatric disorders. |
|
Scientific Title of Study
|
Ketamine for reducing suicidial thoughts in psychiatric disorders. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PEDDESUGARI HARIKA |
| Designation |
post graduate |
| Affiliation |
NRI Academy of Sciences |
| Address |
Department of psychiatry
NRI Medical College
Mangalgiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
08374944710 |
| Fax |
|
| Email |
pharikareddy55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T.V . PAVAN KUMAR |
| Designation |
HOD&PROFESSOR |
| Affiliation |
NRI Academy of Sciences |
| Address |
Department of psychiatry
NRI Medical College
Mangalgiri,Guntur,India
522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9849220263 |
| Fax |
|
| Email |
dr.tvpavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PEDDESUGARI HARIKA |
| Designation |
post graduate |
| Affiliation |
NRI Academy of Sciences |
| Address |
Department of psychiatry
NRI Medical College
Mangalgiri
ANDHRA PRADESH
522503
India |
| Phone |
08374944710 |
| Fax |
|
| Email |
pharikareddy55@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL |
| NRI Medical College
Mangalgiri, Guntur, India 522503 |
|
|
Primary Sponsor
|
| Name |
NRI Academy of Sciences |
| Address |
Department of psychiatry
NRI Medical College
Mangalgiri, guntur. India - 522503 |
| 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 |
| PEDDESUGARI HARIKA |
NRI Academy of sciences |
Nri Medical Colege
mangalgiri
guntur
Guntur
ANDHRA PRADESH |
08374944710
pharikareddy55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC @ NRI MEDICAL COLLEGE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
subanaesthetic doses of iv ketamine, 0.5 mg/kg bd wt
5 sessions on alternate days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Those who are coming to psychiatric and emergency department with ideas of suicide and attempt of suicide. |
|
| ExclusionCriteria |
| Details |
prior cardaic/respiratory/neurological abnormalities
any abnormalities in basic investigations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of subanaesthetic doses of IV Ketamine in reducing suicidal ideation. |
To study the effectiveness of subanaesthetic doses of IV Ketamine in reducing suicidial
ideation. HAM-D, HAM-A MADRS, MSSI after every session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of ketamine sessions required to reduce suicidal ideation.
2..Assess the functional outcome in patients receiving ketamine treatment using Global Assessment Functioning Scale. |
Assess the functional outcome in patients receiving ketamine treatment using global assessment functioning scale after every session |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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)
|
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
|
Emergency department visits for suicidal ideation or behavior have been increasing in all age groups, particularly young adults. In 1964 first tested in humans, in 1970 approved for use in united states. In 1990 found to have mood enhancing properties. In 2000 first controlled study for MDD. MDD do not experience remission with psychotherapy and antidepressants. ketamine appears to be one of the few effective treatment modalities for treatment resistant depression and acute suicidality. With severe unmet needs in bipolar depression, short term ketamine uses in bipolar depression as an add on treatment may be a promising option for severity abatement and social incapacity duration. |