| CTRI Number |
CTRI/2024/06/068694 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence and factors associated with polypharmacy in schizophrenia |
|
Scientific Title of Study
|
Prevalence, socio-demographic and clinical correlates of polypharmacy in schizophrenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Krishna |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, sector 32, Chandigarh
sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9952169162 |
| Fax |
|
| Email |
vijaykrishh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, sector 32, Chandigarh
sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, sector 32, Chandigarh
sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh, 160030 |
| 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 Vijay Krishna |
Government Medical College and Hospital, sector 32, Chandigarh |
Room number 4212, Psychiatry OPD, level 4, B block
Chandigarh
CHANDIGARH |
9952169162
-
vijaykrishh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
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 |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with primary diagnosis of schizophrenia as per ICD- 11
2. Patients on follow up for at least 6 months
3. Patients/ Nominated representative willing to give written informed consent
4. Patients accompanied by a reliable informant
5. Patients between 18-65 years of age
6. Any gender |
|
| ExclusionCriteria |
| Details |
1. Patients already diagnosed with co-morbid psychiatric disorder such as anxiety disorders, depressive disorders, obsessive compulsive disorders, mood disorders and organic disorders.
2. Uncooperative, violent and actively suicidal patients.
3. Persons with co-morbid substance dependence except nicotine and caffeine.
4. Patients with co-morbid Intellectual disability, Alzheimer’s disease, dementia and other neurodegenerative disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence, socio-demographic and clinical correlates of polypharmacy in schizophrenia |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of polypharmacy on psychopathology, quality of life, global functioning, cognitive functions assessed by PANSS, YMRS, CDSS, CGI- S, WHO QOL BREF, GAF, MOCA & the side effects associated with polypharmacy in schizophrenia patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="169"
Sample Size from India="169"
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)
|
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
|
A total of 169 patients with a primary diagnosis of schizophrenia according to ICD-10 or ICD- 11 will be approached. The diagnosis of schizophrenia will be reconfirmed as per ICD- 11 by a clinical interview. Those who satisfy the inclusion, exclusion criteria will be enrolled in the study after obtaining written informed consent from the patient/Nominated Representative. The socio-demographic details shall be recorded in the semi-structured proforma prepared for this study and the information about the current psychotropic treatment prescribed will be noted from the OPD treatment card and screened for polypharmacy using the operational definition of ‘being prescribed 2 or more psychotropics for the same clinical condition’ and prolonged psychotropic polypharmacy definition of ‘being prescribed 2 or more psychotropics for a period of 2 or more months’. On the patients who are identified to be on polypharmacy according to the definitions, the severity of current psychopathology will be assessed by applying Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression- severity scale (CGI- S), Global Assessment of Functioning (GAF) scale, Montreal Cognitive Assessment scale- Hindi (H- MoCA), Calgary Depression Scale for Schizophrenia (CDSS) and Young Mania Rating Scale (YMRS). The quality of life will be assessed by applying WHO Quality of Life scale- Brief Hindi (WHO QoL- BREF). The common side effects of the psychotropics will be assessed with the side effect checklist prepared for this study. The reasons for polypharmacy/symptoms experienced by the patient prior to starting each new drug will be asked to the patient and accompanying reliable informant using the checklist of common reasons of polypharmacy and in case the patient or the informant does not know the reasons/ symptom, the patient’s file record will be examined and the reason for polypharmacy that was documented in the follow-ups will be noted. The reasons for polypharmacy will then be further classified into broad types of polypharmacy. The entire procedure will take 70-80 minutes. |