| CTRI Number |
CTRI/2024/10/074577 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on people with schizophrenia to find and study the occurrence of obsessions and compulsive behaviour
|
|
Scientific Title of Study
|
Co-occurrence of Obsessive compulsive symptoms in patients with schizophrenia and comparison of clinical profile, cognitive and socio-occupational functioning in those with and without Obsessive compulsive symptoms : a cross sectional tertiary hospital based 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 |
DrSujay Shenoy |
| Designation |
Junior Resident in department of Psychiatry |
| Affiliation |
KMC Manipal |
| Address |
Department of Psychiatry,KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9920519657 |
| Fax |
|
| Email |
sujayshenoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshkrishna Bhandary |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
KMC, Manipal |
| Address |
Department of Psychiatry,KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844542567 |
| Fax |
|
| Email |
rajesh.kbp@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeshkrishna Bhandary |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
KMC, Manipal |
| Address |
Department of Psychiatry,KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844542567 |
| Fax |
|
| Email |
rajesh.kbp@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry
Kasturba Medical College, Manipal
Udupi -576104 |
|
|
Primary Sponsor
|
| Name |
PG Research Fund, KMC |
| Address |
Dean office, Kasturba Medical College, Manipal |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sujay Shenoy |
Kasturba Hospital,Manipal |
Department of Psychiatry,
Kasturba Hospital,
Manipal,Udupi, Karnataka
Udupi
KARNATAKA |
9920519657
sujayshenoy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosis of schizophrenia (according to DSM-5)
2) Age group : 18 – 60 years
3) Patients consenting to take part in the study
4) Who are able to understand English/ Kannada and identify English numbers
|
|
| ExclusionCriteria |
| Details |
1) Presence of comorbid neurological condition like stroke, epilepsy, degenerative diseases, Movement disorder etc.
2) Uncontrolled chronic medical conditions like hypertension, diabetes, hypothyroidism
3) Intellectual disability
4) Presence of substance use – except nicotine
5) Comorbid other psychiatry conditions such as Mood Disorder, Personality disorder.
6) History of head injury
7) Autoimmune conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a)Presence of OC symptoms/OCD in patients with schizophrenia.
b)Sociodemographic and clinical variables associated with OC symptoms in Schizophrenia.
c)To compare socio-occupational functioning in people having schizophrenia with and without OCD or OC symptoms.
d)Based on study conducted by Punya Mulky et al.2015 having a sample size of 100 and prevalence of 28%, the sample size estimated for study is 89.
|
At a single time point.Will be assessed at end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of antipsychotic used with OC symptoms |
At a single time point.Will be assessed at end of the study |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="89"
Final Enrollment numbers achieved (Total)= "89"
Final Enrollment numbers achieved (India)="89" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
20/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patients with diagnosis of Schizophrenia will be recruited in to the study. They will be screened for inclusion exclusion criteria using DIAMOND screen. Following rating scales will be administered - BPRS, YBOCS, BCATS and SOFS. OC symptoms will be graded for meeting or not meeting diagnostic criteria. Analysis will be done using SPSS software. |