| CTRI Number |
CTRI/2024/07/070091 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Cognitive Dysfunction and its Relationship With Patients of Schizophrenia |
|
Scientific Title of Study
|
Cognitive Dysfunction And Its Relationship With Psychopathology And Quality Of Life In Patients With Schizophrenia : 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 |
Dr Imyarila Longkumer |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Psychiatry, AVBRH Campus,Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7005195402 |
| Fax |
|
| Email |
imyarila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ragini Patil |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Psychiatry, AVBRH Campus,Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096136123 |
| Fax |
|
| Email |
ragini.tushar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ragini Patil |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Psychiatry, AVBRH Campus,Sawangi Meghe Wardha
MAHARASHTRA
442001
India |
| Phone |
9096136123 |
| Fax |
|
| Email |
ragini.tushar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Sawangi Meghe Wardha,442001, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Sawangi Meghe Wardha,442001, Maharashtra, India |
| 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 Imyarila Longkumer |
Jawaharlal Nehru Medical College |
Department of Psychiatry, AVBRH Campus, Sawangi Meghe
Wardha
MAHARASHTRA |
7005195402
imyarila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are clinically diagnosed to have Schizophrenia using the International Classification of Diseases 10th revision (ICD-10) research criteria
2. Patients within the age group of 18 to 65 years.
3. Patient should be able to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects not willing to give written informed consent.
2. Patients who are acutely ill or not able to cooperate with the study
3. Patients who have a history of developmental delay or any other major organic brain pathology.
4. Patients who had past history of head injury.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of cognitive disfunction in schizophrenia and learn about its relation with negative and positive symptoms of schizophrenia and the quality of life of the patients living with schizophrenia who have cognitive dysfunction. |
The assessment will be done in 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
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)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| 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
|
Cognitive dysfunction is considered to be a
"central characteristic" of schizophrenia. They typically have modest
to severe effects on a variety of cognitive areas. Evidence is mounting that
suggests cognitive impairment may happen far sooner than clinical symptoms. The
connection between cognitive deficiencies and functional outcome indicators has
attracted increasing attention in recent years. The aim of this study is to study cognitive dysfunction and its relationship with quality of life in
patients with schizophrenia. This will be a cross sectional hospital-based
study conducted between the age of 18 to 65 years old with the sample size calculated to be 228. The study being patients
diagnosed with schizophrenia, in the Inpatient and outpatient departments of
Psychiatry. The
patients will then be subjected to the following questionnaires:
1. Sociodemographic Proforma 2. Positive and negative syndrome scale (PANSS) 3.WHO -Quality of Life-BREF
scale (WHOQOL-BREF) and 4. Addenbrooke’s cognitive
examination(ACE) III |