| CTRI Number |
CTRI/2021/02/031325 [Registered on: 16/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to examine effect of level of processing on the recognition memory in patients with schizophrenia and in remission using remember-know paradigm. |
|
Scientific Title of Study
|
Conscious Recollection Deficit for Recognition Memory in Schizophrenia: A Level of Processing Based State vs. Trait Marker Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAHUL JOSHI |
| Designation |
M.PHIL. TRAINEE |
| Affiliation |
LGB REGION INSTITUTE OF MENTAL HEALTH |
| Address |
DEPARTMENT OF CLINICAL PSYCHOLOGY, LGBRIMH, TEZPUR, ASSAM
Sonitpur ASSAM 784001 India |
| Phone |
9838634878 |
| Fax |
|
| Email |
rj2393@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Diptarup Chowdhury |
| Designation |
Assistant Professor |
| Affiliation |
LGB REGION INSTITUTE OF MENTAL HEALTH |
| Address |
DEPARTMENT OF CLINICAL PSYCHOLOGY, LGBRIMH, TEZPUR, ASSAM
Sonitpur ASSAM 784001 India |
| Phone |
03712-233128 |
| Fax |
|
| Email |
dc.tezpur@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RAHUL JOSHI |
| Designation |
M.PHIL. TRAINEE |
| Affiliation |
LGB REGION INSTITUTE OF MENTAL HEALTH |
| Address |
DEPARTMENT OF CLINICAL PSYCHOLOGY, LGBRIMH, TEZPUR, ASSAM
Sonitpur ASSAM 784001 India |
| Phone |
9838634878 |
| Fax |
|
| Email |
rj2393@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF CLINICAL PSYCHOLOGY, LGBRIMH |
|
|
Primary Sponsor
|
| Name |
RAHUL JOSHI |
| Address |
DEPARTMENT OF CLINICAL PSYCHOLOGY, LGBRIMH |
| 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 |
| Rahul Joshi |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
Department of Clinical Psychology, Academic Building Sonitpur ASSAM |
9838634878
rj2393@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LGBRIMH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY NORMAL CONTROLS |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
For Experiment
Group 1 (with active symptoms of schizophrenia)
1 Diagnosis of Schizophrenia according to ICD-10 DCR.
2 Duration of illness: Not more than 5 years
3 Adult onset Schizophrenia
4 At least 6 years of education
5 Able to read and write Assamese
6 Age: 18-45 years
7 Amenable patients
Group 2 (with schizophrenia in remission)
1 Diagnosis of Schizophrenia in remission according to Nancy Andreasen PANSS criteria.
2 Duration of illness: Not more than 5 years
3 Adult onset Schizophrenia
4 At least 6 years of education
5 Able to read and write Assamese
6 Age 18-45 years
7 Amenable patients
For control group
1 Kessler 10, cut-off score less than 10
2 Age and education matched with the experimental group
|
|
| ExclusionCriteria |
| Details |
For Experiment
Group 1 (with active symptoms of schizophrenia)
1 Duration of illness more than 5 years
2 Co-morbid substance dependence
3 History of any other psychiatric illness
4 Co-morbid neurological illness
5 ECT in past 6 months
6 History of development delay
7 IQ < 70
Group 2 (with schizophrenia in remission)
1 Duration of illness more than 5 years
2 Co-morbid substance dependence
3 History of any other psychiatric illness
4 Co-morbid neurological illness
5 ECT in past 6 months
6 History of development delay
7 IQ < 70
For control group
1 Co-morbid substance dependence
2 History of any psychiatric illness
3 Co-morbid neurological illness |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REMEMBER and KNOW RESPONSES (HIT, FALSE ALARM, MISS RATES) AND DEGREE OF CONFIDENCE (1-5) |
SINGLE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Unitary Vs Dual Process of Recollection |
Single |
|
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Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2021 |
| Date of Study Completion (India) |
23/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="11" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recognition memory has two levels, i.e., conscious recollection which is vivid awareness of associated events and familiarity which evokes a sense of knowing in the absence of contextual details. Recollection deficit is consistently seen in individuals with schizophrenia; however, familiarity is intact. Interestingly, recollection deficit has also been reported in the unaffected relatives of persons with schizophrenia. However, whether the deficit is also present in patients who are currently in remission has not been explored. Further, a factor which has previously been found to moderate the performance of individuals with schizophrenia on recognition memory tasks is level of processing (LOP). The present study has been designed to see whether conscious recollection deficit is also present in remitted patients with schizophrenia. Additionally, the effect of LOP on conscious recollection for episodic memory in individuals with schizophrenia will be explored. Conscious recollection and familiarity for recognition memory will be assessed through the Remember/Know paradigm-based task (Tulving, 1985). Effect of level of processing on Remember-Know process will be seen. Additionally, the response pattern of patients in remission will be analyzed, to explore the state vs. trait marker status for conscious recollection deficit. Findings will help in developing remediation programs targeting memory functions for individuals with schizophrenia. |