| CTRI Number |
CTRI/2024/06/069270 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Process of Care Changes
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on using inheritance characters test for medication in new schizophrenia patients in northern India to enhance treatment effectiveness |
|
Scientific Title of Study
|
A study to evaluate the clinical effectiveness of multigenetic pharmacogenomics guided treatment in drug naive schizophrenics in northern Indian population an open label randomized controlled 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 Amrita Kumari Pandey |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8876007338 |
| Fax |
|
| Email |
pandeyamrita301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Farhan Ahmad Khan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9759468300 |
| Fax |
|
| Email |
dr.farhan.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Farhan Ahmad Khan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9759468300 |
| Fax |
|
| Email |
dr.farhan.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Aligarh Muslim university, Medical college road, AMU campus, Aligarh, Uttar Pradesh, pin code-202002 |
|
|
Primary Sponsor
|
| Name |
Dr Amrita Kumari Pandey |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh, Uttar Pradesh, pin code-202002 |
| 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 Amrita Kumari Pandey |
Jawaharlal Nehru Medical College and Hospital |
Departments of Pharmacology and Psychiatry , Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh
202002
Aligarh
UTTAR PRADESH |
8876007338
pandeyamrita301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.),Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh, India - 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multigenetic pharmacogenomic antipsychotic panel test |
Sixty patients will be randomly divided into two groups: group A will receive standard treatment according, and group B will receive pharmacogenomics-guided treatment. Evaluations will be conducted at the end of the 1st, 2nd, and 3rd months. Edit || Delete
|
| Comparator Agent |
Pharmacogenomics-guided treatment versus standard treatment |
Sixty patients will be randomly divided into two groups: group A will receive standard treatment according, and group B will receive pharmacogenomics-guided treatment. Evaluations will be conducted at the end of the 1st, 2nd, and 3rd months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ICD-10 or 11 criteria for schizophrenia
2.Positive and Negative Syndrome Scale (PANSS) more than 60 score
3.Patient or legally authorized representative willing to give informed consent
4.Two generations of the patient living in northern India
5.Schizophrenic patients who have not received any psychotropics
|
|
| ExclusionCriteria |
| Details |
1.Concurrent substance use disorders
2.Neurological conditions
3.Other comorbid axis I psychiatric diagnoses
4.Severe unstable organic illnesses
5.Not able to give consent
6.Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time course of schizophrenia severity which will be measured by the percentage PANSS score change from baseline and at the end of 3 month |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Response or remission rate will be calculated at each time point (1, 2, 3 months) using the PANSS score
Early remission: change of 20 % in PANSS score
Response: more than a 50 % change in PANSS
Complete remission: less than 3 PANSS score
|
18 months |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="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
|
This study aims to compare the clinical effectiveness of multi-genetic pharmacogenomics-guided treatment versus standard treatment in drug-naive schizophrenic patients. Secondary objectives include comparing adverse drug reaction profiles and conducting a cost-benefit analysis. Conducted over 18 months at Jawaharlal Nehru Medical College, AMU, Aligarh, UP, this prospective, parallel-arm, open-label, randomized control trial will involve adult patients diagnosed based on ICD 11 criteria. Participants will undergo comprehensive clinical history assessments and baseline evaluations using the PANSS and CGI scales. Sixty patients will be randomly divided into two groups: Group A will receive standard treatment, and Group B will receive pharmacogenomics-guided treatment. Evaluations will be conducted at the end of the 1st, 2nd, and 3rd months. |