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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY NORMAL CONTROLS 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
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 
 
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.

 
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