| CTRI Number |
CTRI/2024/09/074405 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between two groups of female schizophrenia patients on the basis of blood parameters that of inflammatory markers after giving medication for schizophrenia and to see its effect on the blood parameters of inflammation. |
|
Scientific Title of Study
|
Role of Second generation antipsychotic on level of inflammatory markers in female Schizophrenia patients-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 |
Dr RINCHEN CHOPHEL BHUTIA |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of psychiatry IPGME&R SSKM hospital |
| Address |
Institute of Pschiatry -Department of Psychiatry
Institute Of Post Graduate Medical Education and Research
244 AJC Bose Road
Kolkata
West Bengal-700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
8837287912 |
| Fax |
|
| Email |
rhisahbhutia10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PARAMITA RAY |
| Designation |
Associate Professor |
| Affiliation |
Institute of psychiatry IPGME&R SSKM hospital |
| Address |
Institute of Psychiatry
Institute Of Post Graduate Medical Education and Research
244 AJC Bose Road
Kolkata
West Bengal-700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9474550183 |
| Fax |
|
| Email |
drparomitaraysom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RINCHEN CHOPHEL BHUTIA |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of psychiatry IPGME&R SSKM hospital |
| Address |
Institute of Psychiatry-Department of Psychiatry
Institute Of Post Graduate Medical Education and Research
244 AJC Bose Road
Kolkata
West Bengal-700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
8837287912 |
| Fax |
|
| Email |
rhisahbhutia10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Psychiatry
Institute Of Post Graduate Medical Education and Research ,244
AJC Bose Road
Kolkata- 700020
West Bengal
India. |
|
|
Primary Sponsor
|
| Name |
Institute of Psychiatry |
| Address |
Institute of Psychiatry
Institute Of Post Graduate Medical Education and Research
244 AJC Bose Road
kolkata-700020
West Bengal
India |
| 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 Rinchen Chophel Bhutia |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Institute of Psychiatry
AJC Bose Road
Kolkata
700020
Kolkata
WEST BENGAL |
8837287912
rhisahbhutia10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug naive or off medication female patients diagnosed with schizophrenia according to ICD-11 and DSM-5 . |
Both the groups of female schizophrenia patients treated with second generation antipsychotic either olanzapine or risperidone will be compared based on the effect of it on inflammatory markers like interleukin-6,C-reactive protein,serum ferritin ;before and after the antipsychotic treatment. |
| Intervention |
Drug-second generation antipsychotic
olanzapine and risperidone |
Two groups of females diagnosed with schizophrenia according to ICD-11 and DSM-5 will be given second generation antipsychotic either olanzapine or risperidone and its effect on inflammatory markers like interleukin-6 ,C-reactive protein, serum ferritin will be determined. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.All females cases fulfilling the diagnosis of schizophrenia according to criteria of ICD 11 and DSM-5.
2.Schizophrenia patients (female) who have been off psychotropic medication voluntarily or drug naive patients.
3.Age group 18-45years
4.Patient giving informed consent. |
|
| ExclusionCriteria |
| Details |
1.Male schizophrenia patients.
2.Schizoaffective diagnosed cases.
3.Patients not giving informed consent.
4.History of any other neurodegenerative disorder.
5.History of epilepsy and head injury.
6.History of recent steroid use or iron supplement.
7.Female schizophrenia patients with increased triglycerides and blood sugar. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the inflammatory markers like IL-6 CRP Serum Ferritin in female schizophrenia patients and its relation with Schizophrenia. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the inflammatory markers IL-6 CRP Serum Ferritin after treatment with antipsychotics. |
6 weeks after treatment with antipsychotics. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="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
|
To determine the role of antipsychotics in female Schizophrenia on the levels of inflammatory markers which is known to have been increased in Schizophrenia .In this study two groups of female Schizophrenia patients will be given second generation antipsychotics like Olanzapine and Risperidone .The two groups will be compared based on the change of level of inflammatory markers after the antipsychotic treatment for 6 weeks. |