| CTRI Number |
CTRI/2025/03/082219 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of
Psychotropic induced Movement Disorders.
|
|
Scientific Title of Study
|
Prevalence and Clinical Demographic Profile of
Psychotropic induced Movement Disorders in
Psychiatry in-patients
|
| 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 Harsh Gupta |
| Designation |
Junior Resident |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
Department of Psychiatry
Jawaharlal Nehru Medical College Aligarh Muslim University
Department of Psychiatry
Jawaharlal Nehru Medical College
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7017833753 |
| Fax |
|
| Email |
harshgupta2k17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. R. K. Gaur |
| Designation |
Professor |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
Department of Psychiatry
Jawaharlal Nehru Medical College Aligarh Muslim University
Department of Psychiatry, Jawaharlal Nehru Medical College
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837120329 |
| Fax |
|
| Email |
rkg_amu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof. (Dr) R K Gaur |
| Designation |
Professor |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
Department of Psychiatry
Jawaharlal Nehru Medical College Aligarh Muslim University
Department of Psychiatry, Jawaharlal Nehru Medical College
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837120329 |
| Fax |
|
| Email |
rkg_amu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical college hospital |
|
|
Primary Sponsor
|
| Name |
Dr Harsh Gupta |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, AMU, Aligarh 202002
AMU Campus, Medical Road, Aligarh |
| 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 Harsh gupta |
Jawaharlal Nehru Medical College and Hospital |
OPD number 8, OPD Block Jawaharlal Nehru Medical College, AMU
Aligarh
UTTAR PRADESH |
7017833753
harshgupta2k17@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: G259||Extrapyramidal and movement disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients age more than 18yrs
2. Patients of either gender
3. Patient admitted in Psychiatric ward
4. Patients who are on Psychotropic medications
5. Patients who will give informed consent
|
|
| ExclusionCriteria |
| Details |
â—Age below 18yrs of age
â—Patient suffering from any neurological /movement disorder.
â—Patients Who will not giving informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to asses the frequency of psychotropic induced movement disorder. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
â—To study clinical demographic profile of patients with psychotropic induced movement disorder.
â—To study association between psychotropic induced movement disorder and clinical demographic
profile.
|
2 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2025 |
| 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="2"
Months="0"
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
study the prevalence of psychotropic induced movement disorder with secondary objective of studying clinical demographic profile of patients with psychotropic induced
movement disorder and to
study association between psychotropic induced movement disorder and clinical
demographic profile. It will be an Institution based Cross-sectional study conducted in Psychiatry In-Patient
Department, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh on patients meting inclusion and exclusion criteria. Demographic
and clinical data of patients will be collected by a semi-structured proforma and Psychotropic
medications induced movement disorders will be assessed by using Unified Drug-Induced Movement Disorders Scale
(UDIMS). |