CTRI Number |
CTRI/2019/01/017302 [Registered on: 28/01/2019] Trial Registered Prospectively |
Last Modified On: |
15/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study comparing vilazodone with escitalopram in terms of efficacy , safety and onset of action in patients with depression. |
Scientific Title of Study
|
A comparative study of efficacy, safety and onset of action of vilazodone with escitalopram in patients of major depressive disorder at tertiary care hospital. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ankushe Rohini |
Designation |
Junior Resident-1, Department of Pharmacology ,Government Medical College, Latur. |
Affiliation |
Government Medical College ,Latur . |
Address |
Department of Pharmacology, Government Medical College, Latur-413512 .
Latur MAHARASHTRA 413512 India |
Phone |
8310831326 |
Fax |
|
Email |
ankusherohini@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr VS Deshmukh |
Designation |
Associate Professor, Department of Pharmacology,Government Medical College ,Latur -413512. |
Affiliation |
Government Medical College, Latur. |
Address |
Department of Pharmacology,Government Medical College ,Latur -413512.
Latur MAHARASHTRA 413512 India |
Phone |
09405102432 |
Fax |
|
Email |
vinod_deshmukh88@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ankushe Rohini |
Designation |
Junior Resident -1, Department of Pharmacology ,Government Medical College Latur. |
Affiliation |
Government Medical College, Latur . |
Address |
Department of Pharmacology,Government Medical College, Latur-413512.
Latur MAHARASHTRA 413512 India |
Phone |
8310831326 |
Fax |
|
Email |
ankusherohini@gmail.com |
|
Source of Monetary or Material Support
|
Government Medical College,
Latur,Maharashtra 413512. |
|
Primary Sponsor
|
Name |
Dr Ankushe rohini |
Address |
flat no.5, Dhanvantari building ,Gandhi Chawk Latur 413512. |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr VSDeshmukh |
Flat no-204,B wing,Omkar Residancy ,Ganesh nagar,Ambejogai Road Latur-413531 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ankushe Rohini |
Government Medical College ,Latur. |
OPD No.25,Department of Psychiatry . Latur MAHARASHTRA |
8310831326
ankusherohini@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Government Medical College, Latur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Tablet Escitalopram OD orally. |
Drug will be started at a dose of 5 mg, dose will be increased every week by 5mg (max.upto 20mg)if inadequate response is obtained. |
Intervention |
Tablet Vilazodone OD orally. |
Drug will be started at a dose of 10mg,dose will be increased every week by 10mg(max upto 40 mg)if inadequate response is obtained. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1)Patients of either sex with age between 18 to
65 years.
2)Newly diagnosed MDD patients meeting DSM- 5
criteria for depression.
3)Patient who give written informed consent.
|
|
ExclusionCriteria |
Details |
1)Pregnant or nursing women.
2)Patients with high risk of suicidal tendency
or previous suicide attempt within 6 months.
3)Patients with bipolar disorder, drug abuse or
dependency, post traumatic stress disorder,
obsessive – compulsive disorder.
4)Patients with previous depression resistant to
antidepressants and those who had taken treatment
with electroconvulsive therapy in previous 3
months or formal psychotherapy within 1 month.
5)Patients on other antidepressants.
6)Patients with neurological disorders (dementia,
seizures, stroke), obesity with functional
impairment, serious or unstable organic disorder
(neoplasia, cardiovascular, pulmonary,uncontrolled
type 1 or 2 diabetes).
7)Any other medical disorder which is confounding
our inclusion diagnosis.
8)Patients with drug intake for psychosis or anxiety.
9)Any history of allergy to the drugs.
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Outcome name : 1)Hamilton Depression Rating Scale.(used for sample size calculation. )
2)Udvalg for Kliniske Undersolgelser(UKU)scale.
3)Blood investigations[CBC, SGOT,SGPT ,serum bilirubin(direct and indirect)
serum creatinine & serum urea.] |
Time point : 12 weeks . |
|
Secondary Outcome
|
Outcome |
TimePoints |
Outcome name: 1)Hamilton Anxiety Rating Scale(HAM-A).
2)Montgomery-Asberg Depression Rating Scale(MADRS).
3)Clinical Global Impression Scale(CGI)involving,
Clinical Global Impression-Severity(CGI-S) and
Clinical Global Impression-Improvement(CGI-I)score. |
Time point: 12 weeks |
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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
|
Phase 4 |
Date of First Enrollment (India)
|
01/02/2019 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None yet. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
A prospective, randomized, active–controlled, parallel–group comparative
open label study will be conducted on total 92 patients of major depressive
disorder at psychiatry OPD, meeting inclusion criteria, after permission of
Institutional ethics committee. Prior permission from head of department of
pharmacology, psychiatry, pathology, biochemistry, will be taken. Registration
to clinical trial registry (CTRI) will be done. GCP guidelines will
be strictly followed. Diagnosis of patient as a patient of major depressive disorder will be
done by psychiatrist. A written informed consent from the patient or legal
guardian of patient will be taken after explaining nature and purpose of study
in their own language. Patient information sheet containing all the necessary
details of study will be provided to patient. Eligible patients will be
randomized using block permutation method with allocation ratio of 1:1 to
receive either escitalopram or vilazodone. Patient’s details will be
taken on a proforma, including patients age ,sex, occupation , religion,
marital status ,type of family , total family members , total income, per capita
income, socio -economic class (by B.G. Prasad classification) ,history of any medical illness , duration and treatment
received for the same will be recorded.
Family h/o any psychiatric disorder will also be taken. Also patient’s
weight, BP, will be recorded. Weight of patient will be taken on a same type
digital weighing machine throughout the study. BP of patient will be recorded
with same type of sphygmomanometer till the end of study. CBC, serum
creatinine, serum urea, liver function tests will be done, at baseline (day 1),
4thweek, and at 12 weeks at the same institution with same method. Before starting treatment, baseline(day 1)Hamilton depression rating
scale (HAM- D),Hamilton anxiety rating scale (HAM –A) ,Montgomery –Asberg
Depression rating scale (MADRS), clinical global impression- severity (CGI-S)
score will be taken, also baseline(day 1)
blood investigations such as CBS, LFT ,RFT will be done after
which treatment with either vilazodone (10mg ) or Escitalopram(5mg)
orally as prescribed by psychiatrist will be started. Patient will be advised
to take vilazodone with food. Dose of the drug will be doubled every week maximum
upto 40 mg for vilazodone and for escitalopram dose will be increased by 5mg
every week maximum upto 20mg if inadequate response is obtained .
Subsequent
follow -up will be taken at 1st , 2nd ,4 th and
12th week and changes in the HAM –D , HAM–A, MADRS , clinical global
impression improvement (CGI –I) and clinical global impression severity (CGI-S)
Score will be recorded. Follow up blood investigation will be done at 4th
and 12th week. The primary efficacy outcomes will be taken as change
from the baseline in the values of HAM-D17 total score (change from
baseline to last post baseline assessment).secondary outcome measurers will be
HAM –A, MADRS and CGI-I, CGI–S score, total 50% reduction in scores will be
considered as response to therapy.
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