| CTRI Number |
CTRI/2018/06/014537 [Registered on: 15/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of SSRI and SNRI on various mental activities including learning and problem solving among patients suffering from major depressive disorder |
|
Scientific Title of Study
|
A prospective, observational study to assess the effects of SSRI and SNRI on cognitive function in patients of Major Depressive Disorders (MDD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayanta Thakur |
| Designation |
Resident |
| Affiliation |
Department Of Pharmacology Institute of Post Graduate Medical Education and Research |
| Address |
244 AJC Bose Road
Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
8017032224 |
| Fax |
|
| Email |
tsayanta83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suparna Chatterjee |
| Designation |
Professor |
| Affiliation |
Department Of Pharmacology Institute of Post Graduate Medical Education and Research |
| Address |
244 AJC Bose Road
Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831130980 |
| Fax |
|
| Email |
drsupchat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suparna Chatterjee |
| Designation |
Professor |
| Affiliation |
Department Of Pharmacology Institute of Post Graduate Medical Education and Research |
| Address |
244 AJC Bose Road
Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831130980 |
| Fax |
|
| Email |
drsupchat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology
Institute of Post-Graduate Medical Education and Research,244, A.J.C. Bose Road, Bhowanipore, Kolkata, West Bengal 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology IPGMER |
| Address |
244 AJC Bose Road
Kolkata-700020 |
| Type of Sponsor |
Government 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 Sayanta Thakur |
Institute Of Psychiatry |
Out Patient Department,
Institute Of Psychiatry
7 D L Khan Road
Kolkata
WEST BENGAL |
8017032224
tsayanta83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All adult diagnosed patients of MDD as per ICD 10 criteria in remission phase, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients (18 years to 50 years) of either gender attending psychiatry OPD at IOP,
with a clinical diagnosis of Major Depressive Disorder as per ICD10 criteria.
2)Subjects of MDD must be in remission phase with a Hamilton Depressive Rating Score (HAM-D 17) of <7) at enrolment and taking any of the following SSRIs - fluoxetine, sertraline, escitalopram and/or SNRI like mirtazapine for at least last 6 months. Patients who are additionally on cognitive behavioral therapy (CBT) as part of their treatment shall also be included.
3)Subjects should have at least 8 years of formal school education in order to undertake the cognitive function tests.
4)Subjects or their care givers should be willing to give written informed.
|
|
| ExclusionCriteria |
| Details |
1)History of post traumatic or Obsessive compulsive Disorder (OCD)
2)History of schizophrenia, psychosis or bipolar delusional disorder
3)History of intake of any drugs that are likely to have effect on cognition (anticonvulsants, sedative hypnotics, neuroleptics, opioids)
4)History of addictions- alcohol, substance abuse
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in cognitive function score |
Attime points- 3, 6 and 9 months from the date of commencement of study.Both the absolute changes and percentage change from enrollment visit to 9 months visit shall be computed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the nature of the changes in different domains of cognitive functions and to analyze whether there are any observable differences in the effects of the individual drugs on cognitive function. |
At time points- 3, 6 and 9 months from the date of commencement of study. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to study the effects of SSRI and SNRI on various domains of cognitive functions in patients with Major Depressive Illness. The secondary purpose of the study is to asses the nature of cognitive function changes due to use of drugs of interest. |