| CTRI Number |
CTRI/2021/10/037093 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the effectiveness of Ketamine in persons suffering from bipolar depression |
|
Scientific Title of Study
|
A randomised clinical study on the effectiveness of Ketamine vs Placebo in the treatment of bipolar depression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
No 11, Subburam street,
Gandhinagar, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
09443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
No 11, Subburam street,
Gandhinagar, Madurai
TAMIL NADU
625020
India |
| Phone |
09443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
No 11, Subburam street,
Gandhinagar, Madurai
TAMIL NADU
625020
India |
| Phone |
09443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
|
Source of Monetary or Material Support
|
| Ahana hospitals, LLP
Madurai-625020 |
|
|
Primary Sponsor
|
| Name |
Ahana hospitals LLP |
| Address |
No.11, Subburam street, Gandhinagar, Madurai - 625020
Tamilnadu, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vikhram Ramasubramanian |
Ahana hospitals LLP |
Department of Psychiatry
No.11, Subburam street, Gandhinagar, Madurai
Madurai
TAMIL NADU |
09443772233
vikhram@ahanahospitals.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Radianz Healthcare and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, (2) ICD-10 Condition: F314||Bipolar disorder, current episodedepressed, severe, without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine infusion |
Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Sub-anesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have been diagnosed with Bipolar affective disorder. Ketamine is not FDA approved for this indication and its effectiveness in Bipolar depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for bipolar depression . |
| Comparator Agent |
Midazolam |
The benzodiazepine midazolam mimics some of the acute effects of ketamine at low doses but has no known antidepressant effect and has therefore been used as an active comparator to try to improve blinding in clinical trials |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Written informed consent.
Patients diagnosed with bipolar affective disorder current episode depression as per ICD 10 guidelines
Patients started on antidepressants specifically SNRIs
|
|
| ExclusionCriteria |
| Details |
Co-morbid psychiatric diagnoses such
as psychosis, substance dependence
Mental retardation, neurological disorders, and severe medical illness
Pregnancy or breastfeeding
Allergy to ketamine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) – approximately 7th day]
Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit.
|
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) – approximately 7th day]
Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 7th day ]
Number of patients with an improvement in their Baseline CGI score at the End of Treatment Visit. The End of Treatment Visit will occur in 7th day after the Baseline Visit.
|
baseline and 7th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/10/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vikhram@ahanahospitals.in].
- For how long will this data be available start date provided 28-02-2022 and end date provided 31-05-2022?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ketamine is a competitive glutamate
Nmethyl- D-aspartate receptor antagonist and it has a rapid antidepressant
effect and provides rapid relief to persons suffering from depression. There
are numerous studies that have proven the effectiveness of ketamine in the
treatment of severe depression but there are no known studies that evaluate its
effectiveness in the treatment of bipolar depression. This randomized,
controlled single-blind study hopes to find if ketamine could be used to treat
bipolar depression. This study uses the benzodiazepine Midazolam, which does
not have any antidepressant effect but can mimic the effects of ketamine, as an
active comparator in blinding the control in this clinical trial. |