FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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.



 
Close