| CTRI Number |
CTRI/2024/03/063851 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mental problems in patients with Parkinson disease |
|
Scientific Title of Study
|
Psychiatric comorbidities of Parkinsonism in a tertiary care center in South India:
A cross sectional 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 |
Adityo Khastgir |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal, Udupi |
| Address |
Department of Psychiatry, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9901503475 |
| Fax |
|
| Email |
adityo.khastgir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir Kumar Praharaj |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal, Udupi |
| Address |
Department of Psychiatry, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8971026304 |
| Fax |
|
| Email |
samir.kp@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samir Kumar Praharaj |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal, Udupi |
| Address |
Department of Psychiatry, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8971026304 |
| Fax |
|
| Email |
samir.kp@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Adityo Khastgir |
| Address |
OPD No 33- Kasturba Medical College, Tiger circle, Manipal, Udupi district, 576104 |
| Type of Sponsor |
Private 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 Adityo Khastgir |
Kasturba Hospital, Manipal |
OPD No 33,3rd floor, Department of Psychiatry, Kasturba Medical College, Tiger circle, Manipal, Udupi district, 576104
OPD No 11,1st floor, Department of Neurology, Kasturba Medical College,Tiger circle, Manipal, Udupi district, 576104
Udupi
KARNATAKA |
9901503475
adityo.khastgir@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutions Ethics Committee |
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, (2) ICD-10 Condition: F30-F39||Mood [affective] disorders, (3) ICD-10 Condition: F01-F09||Mental disorders due to known physiological conditions, (4) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, (5) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (6) ICD-10 Condition: F50-F59||Behavioral syndromes associated with physiological disturbances and physical factors, (7) ICD-10 Condition: F60-F69||Disorders of adult personality and behavior, (8) ICD-10 Condition: G20||Parkinsons disease, (9) ICD-10 Condition: G21||Secondary parkinsonism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical diagnosis of Parkinsonism.
2. Patients of any gender above the age of 18.
3. Patients who can give written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patients who are frail, not able to cooperate with evaluation.
2. Drug-induced Parkinsonism based on history of exposure to antipsychotic. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of psychiatric comorbidities as measured by Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders
(DIAMOND),Unified Parkinsons disease Rating Scale (UPDRS),Neuropsychiatry Inventory (NPI) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity assessments using UPDRS & NPI |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
15/03/2024 |
| 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="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
|
The aim of the study is to understand the mental disorders of Parkinsonism in South India. The implication of this study is that it is relevant to clinical practice to know the various mental health conditions in parkinsonism to ensure proper identification and management . Patients meeting the inclusion criteria with clinical diagnosis of Parkinsonism will be recruited after obtaining the written informed consent. They will interviewed in detail using the DIAMOND criteria for the mental health conditions and sociodemographic data and clinical proforma, specially desgined for the study will be used to gather data. Relevant scales will be applied. Data analysis with approproate statistical tests will be done subsequently. |