| CTRI Number |
CTRI/2024/07/071680 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A study of the safety of Risperidone with Olanzapine
in new psychosis patients |
|
Scientific Title of Study
|
A comparative study of the safety of Risperidone with Olanzapine in patients of new-onset psychosis |
| 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 Ashish Bansal |
| Designation |
Junior Resident |
| Affiliation |
Dr.Rajendra Prasad Government Medical college |
| Address |
Pharmacology Department, Para-Clinical Block, Dr.Rajendra Prasad Government Medical college, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9736450318 |
| Fax |
|
| Email |
bansalashish124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Sood |
| Designation |
Professor & Head |
| Affiliation |
Dr.Rajendra Prasad Government Medical college |
| Address |
Pharmacology Department, Para-Clinical Block, Dr.Rajendra Prasad Government Medical college, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418063191 |
| Fax |
|
| Email |
atalsood7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Bansal |
| Designation |
Junior Resident |
| Affiliation |
Dr.Rajendra Prasad Government Medical college |
| Address |
Pharmacology Department, Para-Clinical Block, Dr.Rajendra Prasad Government Medical college, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9736450318 |
| Fax |
|
| Email |
bansalashish124@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Rajendra Prasad Government Medical College, Kangra at Tanda, Himachal Pradesh, India
pin code:176001 |
|
|
Primary Sponsor
|
| Name |
DrRajendra Prasad Government Medical college |
| Address |
Pharmacology Department, Para-Clinical block, Dr RPGMC, Kangra at Tanda, Himachal Pradesh, india
pincode:176001 |
| 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 |
| Dr Ashish Bansal |
Dr. Rajendra Prasad Government Medical college, Kangra at Tanda, H.P, India |
Department of Psychiarty and room no 815, Department of PharmacologyDr. Rajendra Prasad Government Medical college, Kangra at Tanda, H.P, India
Kangra
HIMACHAL PRADESH |
9736450318
bansalashish124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Rajendra Prasad Government Medical college, Kangra at Tanda, H.P, 176001. Instituinal Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Olanzapine |
tab. olanzapine 5 mg to 30 mg once daily will be given to the patient orally for 6 months |
| Intervention |
Risperidone |
tab. risperidone 2 to 8 mg once daily will be given to patient orally for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All newly diagnosed adult patients of psychosis without any other co-morbidities.
All newly diagnosed adult patients of psychosis who are willing to give consent.
|
|
| ExclusionCriteria |
| Details |
Patients not willing to give written informed consent
Pregnant females
Patients already on treatment with study drugs
Patients with known contra-indication or refractoriness to study drugs
Patients with known history of heart disease
Patients with known hypersensitivity to study drugs
Patients with history of epilepsy & other neurological disorders
Patients with a high risk of suicidal tendency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| which drug is safer in terms of adverse effects. |
from baseline over a period 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
20/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Psychosis is the combination of psychological symptoms leading to a disconnection from reality. Delusions, hallucinations, and abnormal thought patterns are the main ones. It refers to the perception of unreal sounds, sights, or sensations. For example, a person may experience delusions like seeing objects that aren’t there, hearing voices, smelling scents, tasting something "off," or experiencing skin sensations when nothing is actually touching them. A delusion is a false fixed belief that is not amenable to change in light of conflicting evidence.
We are comparing Resperidone with Olanzapine for safety in new onset Psycosis patients. Publications will be done using the data and results obtained during the research. |