| CTRI Number |
CTRI/2023/12/060893 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study on How Different Ways of Interpreting Information and Recollecting Memory Affect the Inability to Experience Pleasure in People with Depression |
|
Scientific Title of Study
|
Effect of Elemental Processing and Levels of Recollection for Recognition Memory on the Experience of Anhedonia in Persons with Depressive Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Sunilkumar Sharma |
| Designation |
M. Phil in Clinical Psychology Trainee |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur |
| Address |
Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
6351572721 |
| Fax |
|
| Email |
deepak.s13894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diptarup Chowdhury |
| Designation |
Associate Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur |
| Address |
Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
03712233128 |
| Fax |
|
| Email |
dc.tezpur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshee Abhishek |
| Designation |
Assistant Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur |
| Address |
Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
03712233088 |
| Fax |
|
| Email |
psy.pabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Clinical Psychology, LGBRIMH, Tezpur, Assam |
|
|
Primary Sponsor
|
| Name |
Deepak Sunilkumar Sharma |
| Address |
Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Sonitpur, Assam - 784001 |
| 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 |
| Deepak Sunilkumar Sharma |
LGB Regional Institute of Mental Health |
Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Sonitpur, Assam - 784001
Sonitpur
ASSAM |
6351572721
deepak.s13894@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No diagnosis of psychiatric or medical illness |
| Patients |
(1) ICD-10 Condition: F334||Major depressive disorder, recurrent, in remission, (2) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (3) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (4) ICD-10 Condition: F325||Major depressive disorder, singleepisode, in full remission, (5) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (6) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis: Major Depressive Episode with active symptoms, individuals with depressive disorder in remission (A score of less than 7 on Hamilton Depression Rating Scale), and healthy individuals (no diagnosis)
Education: Class 6 or higher |
|
| ExclusionCriteria |
| Details |
Individuals with a history of head injury, organic brain syndrome, symptoms suggestive of seizures, intellectual disability or any severe physical illness.
Individuals with severe depression, active suicidal ideation, or any severe comorbid psychopathology, including psychotic symptoms, Obsessive Compulsive Disorder, Bipolar Depression, Substance Intoxication, Dependence or Withdrawal, and Severe Personality Psychopathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
HAM-D score as a measure of severity of depression
Anhedonia score on SHAPS-C as a measure of anhedonia
Performances (% correct responses) on biconditional discrimination task and simple discrimination task as measures of processing styles
Performance (% correct response) on Remember-Know task as a measure of recognition memory recollection |
Single [Cross-sectional study] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2024 |
| Date of Study Completion (India) |
28/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
Modification(s)
|
Individuals with
depressive disorder did not differ significantly from healthy participants in
terms of information processing style or recognition of episodic memory. The
processing style and patterns of recollection of recognition memory did not
have any significant relationship with the experience of anhedonia in
individuals with depressive disorder. The present study did not find any effect of information processing
style and patterns of recollection of recognition memory on the experience of
anhedonia in individuals with depressive disorder, unlike previous studies
conducted on individuals with schizophrenia. It may indicate the possibility
that the presentation and cognitive correlates of anhedonia in the two
psychiatric conditions may be different, despite the transdiagnostic nature of
anhedonia.
|