| CTRI Number |
CTRI/2025/07/090034 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| 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 study to see if adding ondansetron to fluoxetine helps reduce symptoms of obsessive-compulsive disorder (OCD).
|
|
Scientific Title of Study
|
Evaluating The Efficacy And Safety Of Ondansetron As Augmentation Of Fluoxetine In Obsessive-Compulsive Disorder:
A Comparative Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Kulhar |
| Designation |
PG Student |
| Affiliation |
SN Medical College Agra |
| Address |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
9929550855 |
| Fax |
|
| Email |
nidhikulhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashutosh Kumar |
| Designation |
Associate Prof. |
| Affiliation |
SN Medical College Agra |
| Address |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
9837092520 |
| Fax |
|
| Email |
drashutoshkg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Kulhar |
| Designation |
PG Student |
| Affiliation |
SN Medical College Agra |
| Address |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
9929550855 |
| Fax |
|
| Email |
nidhikulhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SN Medical College, Agra, Uttar Pradesh, India- 282003 |
|
|
Primary Sponsor
|
| Name |
SN Medical College |
| Address |
Department of Psychiatry S N Medical College Agra, 282003 |
| Type of Sponsor |
Government 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 |
| Nidhi Kulhar |
SN Medical College, Agra |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH |
09929550855
nidhikulhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SN MEDICAL COLLEGE, AGRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Fluoxetine |
only standard treatment for OCD will be given(Tab Fluoxetine 20 mg to 80 mg will be given orally in single or divided dose for 8 weeks) |
| Intervention |
Tab Ondansetron |
tab ondansetron 4mg-8mg will be given orally in 2 divided dose for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in the study and has given written informed consent.
2.Age group 18-60 years.
3.Patients diagnosed with Obsessive-Compulsive Disorder according to DSM-5 TR.(12)
4.Currently naïve or off any psychotropic medication for at least 6 weeks.
|
|
| ExclusionCriteria |
| Details |
1.Treatment resistant OCD (2 adequate SSRI trial for 12 weeks)
2.History of non response to prior trial of fluoxetine with ondansetron.
3.Patient having severe psychiatric or medical comorbidities except depression.
4.Substance use disorder except nicotine and caffeine.
5.Pregnancy or lactation.
6.Patients with history of adverse reaction to study medications.
7.Inability to provide informed consent.
8.Patient with psychotic symptoms due to other organic illness.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales
|
Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales
|
|
|
Secondary Outcome
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2026 |
| 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="0"
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
|
Potential participants will be screened for eligibility based on the inclusion and exclusion criteria.Participants will undergo baseline assessments to collect demographic information, medical history, psychiatric history, and baseline clinical variables will be measuresd YBOCS Scale And Symptoms Checklist, MADRS, HAM-A and CGI-I Scale.Participants will be randomized to either the ondansetron augmentation group (Group A) or the no augmentation group (group B). Fluoxetine therapy will be given in both the groups. Benzodiazepines (Lorazepam) upto 3 mg/day and beta-blocker (Propranolol) at a dose of 20-80 mg/day can be used as concomitant medication, if required.Participants will undergo regular follow-up assessments at 4 week and 8 week, Outcome measures including severity of OCD , depression and overall improvement will be assessed using standardized Scales |