| CTRI Number |
CTRI/2025/03/083287 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on patients diagnosed with psychotic disorders to know antipsychotic drug use pattern . |
|
Scientific Title of Study
|
A Descriptive Observational Study on Prescribing Pattern of Antipsychotic Drugs Among Outpatients Attending Department of Psychiatry at Sawai Man Singh Medical College, and Attached Hospitals, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Beserwal |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, JLN Marg,Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8005870543 |
| Fax |
|
| Email |
anjalibeserwal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupa Kapadia |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, JLN Marg,Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929871911 |
| Fax |
|
| Email |
drrupakapadia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Beserwal |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, JLN Marg,Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8005870543 |
| Fax |
|
| Email |
anjalibeserwal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College and Hospital, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan, India Pincode - 302004 |
|
|
Primary Sponsor
|
| Name |
Anjali Beserwal |
| Address |
Sawai Man Singh Medical College,Jaipur,Rajasthan,India
Pincode -302004 |
| 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 |
| Anjali Beserwal |
Sawai Man Singh Hospital |
Outpatient department, Department of Psychiatry, Sawai Man Singh Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
8005870543
anjalibeserwal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed patients of psychosis prescribed with atleast one antipsychotic drug.
2. Patients of age above 18 years of either sex.
3. Patients willing to participate and give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Critically ill,non-cooperative patients.
2. Patients diagnosed with organic disorders caused due to brain trauma, blood loss and diseases like Parkinson disease and Alzheimer disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Average number of drugs per prescription.
2.Percentage of drugs prescribed with generic name.
3.Percentage of drugs prescribed from the National Essential Drug List ( NEDL),2022.
4.Percentage of prescriptions with antibiotics prescribed.
5.Percentage of prescriptions with injections prescribed. |
1. 6 months
2. 6 months
3. 6 months
4. 6 months
5. 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Classification of drugs according to the Anatomical Therapeutic Chemical
Classification.
2.Calculation of Daily Defined Dosage of prescribed drugs.
3.Percentage of patients having effect on the mental health and quality of life being prescribed antipsychotic drugs by using MHQOL-7D Questionnaire. |
1. 6 months
2. 6 months
3. 6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
04/04/2025 |
| 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="3"
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
|
The purpose of study is to evaluate the drug prescribing pattern of antipsychotic drugs as per WHO core indicators in outpatient department of psychiatry, SMS College and Attached Hospital . The study will give an insight to understand the prescribing pattern of antipsychotic drugs and to assess the mental health and quality of life in patients being prescribed with antipsychotic drugs attending the Outpatient Department of Psychiatry. |