| CTRI Number |
CTRI/2022/03/040911 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the effect of neurocognitive functions as a predictor of functional outcome in patients with schizophrenia |
|
Scientific Title of Study
|
A Study on Neurocognitive Functions as a Predictor of Functional Outcome in Patients with Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Subasana Kashyap |
| Designation |
M. Phil trainee |
| Affiliation |
LGB Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology, LGBRIMH, Tezpur-784001, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9401783537 |
| Fax |
|
| Email |
subasanakashyap187@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diptarup Chowdhury |
| Designation |
Associate Professor |
| Affiliation |
LGB Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology(Academic block 5th floor), LGBRIMH, Tezpur-784001, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
03712-233128 |
| Fax |
|
| Email |
dc.tezpur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Abhishek |
| Designation |
Assistant Professor |
| Affiliation |
LGB Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology(Academic block 5th floor), LGBRIMH, Tezpur-784001, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9476916081 |
| Fax |
|
| Email |
psy.pabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| LGB Regional Institute of Mental Health, Tezpur-784001, Assam. |
|
|
Primary Sponsor
|
| Name |
Subasana Kashyap |
| Address |
LGB Regional Institute of Mental Health
Tezpur-784001
Dist: Sonitpur |
| 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 |
| Subasana Kashyap |
LGB Regional Institute of Mental Health |
Out patient department and Inpatient department
Tezpur-784001
District:Sonitpur
Assam.
Sonitpur
ASSAM |
9401783537
subasanakashyap187@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with schizophrenia as per ICD 10 CDDG(F20.0-F20.9),visiting LGBRIMH from different localities of Assam, who provide informed consent to participate in the study ,with normal to corrected to normal vision. |
|
| ExclusionCriteria |
| Details |
Patients with comorbid neurological illness as obtained through medical record file and who have not received ECT in past one month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The current study would be helpful in understanding the effect of selected neuropsychological tools in predicting functional outcome in patients with schizophrenia. It would also help in portraying effect of clinical and socio-demographic factors as mediator and moderator variables respectively in predicting functional outcome in patients with schizophrenia, with neurocognitive functions serving as independent variable and functional outcome dependent variable. |
Baseline(01) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop cognitive remediation strategies for this group of patients, based on the obtained mediating and moderating factors |
Baseline(01) |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
17/03/2022 |
| 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="0"
Months="10"
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
|
Neuro-cognitive deficits constitute one of the core areas of deficits witnessed in patients with schizophrenia. Among neuro cognitive deficits, memory functions and executive functions are the two robust areas where impairments are noticed in this group of patients. Like cognitive deficits, functional deficits too are present in most patients with schizophrenia at the onset of illness and level of impairment is quite substantial. Different cognitive test batteries such as Measurement and treatment research to improve cognition in schizophrenia (MATRICS), Consensus Cognitive Battery (MCCBTM), Cogstate have been developed with the objectives of providing brief evaluations of key cognitive domains related to schizophrenia, to improve clinical research and care around the world. All of these batteries are based on western norms and have not been standardized on Indian population. The present study aims at exploring the predictive sensitivity of commonly used Indian neuropsychological tools for the assessment of prefrontal lobe and medial temporal lobe functions in predicting the functional outcome in patients with schizophrenia. Additionally, the study will also explore the role of clinical and socio-demographic factors in mediating and moderating the relationship respectively, between neuropsychological functioning and functional outcome. |