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CTRI Number  CTRI/2013/11/004127 [Registered on: 04/11/2013] Trial Registered Retrospectively
Last Modified On: 20/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A phase-III clinical trial to study the effects of Vilazodone in Indian patients with depression. 
Scientific Title of Study   A Randomized, Multicenter, Open Label, Placebo Controlled Study to Evaluate the Efficacy, Tolerability, and Safety of Vilazodone in Indian Adult Patients with Major Depressive Disorder (MDD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/VIDE/10/2012, Version 1.0, dated 26-Oct-2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Associate Vice-President and Head 
Affiliation  Hetero Group 
Address  Clinical Development and Medical Affairs, Hetero Drugs Limited, “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Associate Vice-President and Head 
Affiliation   
Address  Clinical Development and Medical Affairs, Hetero Drugs Limited, “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited, “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India,  
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishal N Vora MD DPM  AMC MET Medical College and Sheth L.G.General Hospital  Asst. Professor,Dept. of Psychiatry, AMC MET Medical College and Sheth L.G.General Hospital, Ahmedabad-380008
Ahmadabad
GUJARAT 		 079-25472101

vnvora@gmail.com 
Dr Jairanjan Ram MBBS MRC Psych MD Psychiatry CCST   Apollo Gleneagles Hospital  Deaprtment of Psychiatry, Apollo Gleneagles Hospital,58,Canal CircularRoad,Kolkata-700054
Kolkata
WEST BENGAL 		 033-23203040

groovypsych@hotmail.com 
Dr Kasthuri Pandiyan MD  Bangalore Medical College and Research Institute  Bangalore Medical College and Research Institute, K.R.Road, Fort, Bangalore-560002
Bangalore
KARNATAKA 		 09845792600

drkasthurip@yahoo.com 
Dr Pradeep Kumar Saha MD  IPGME & R  Institute of Psychiatry, IPGME & R, 244AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL 		 09830277607

pradeepnimhan@gmail.com 
Dr Anil Nischal MD Psychiatry  King George Medical University  Associate Professor, Dept. of Psychiatry,King George Medical University, Lucknow-226003, UP, India
Lucknow
UTTAR PRADESH 		 0522-2257450
0522-2250642
an.kgmu@gmail.com 
Dr Kalyan Chakravarthy MD MRC Psych  Mediciti Hospital  Consultant Adult&Child Neuro Psychiatrist, Department of Psychiatry, Mediciti Hospital 5-9-22, Secretariat Road, Hyderabad 50001 Hyderabad ANDHRA PRADESH
Hyderabad
ANDHRA PRADESH 		 040-23231111

drkalyan@live.com 
DrSiquafa Zafreen Khanum MD  Nirmal Hospital  Nirmal Hospital, Opp .MLB Medical College, Gate no-3, Jhansi-284128, Uttar Pradesh
Jhansi
UTTAR PRADESH 		 0510-2321001

drsiquafazafreen@gmail.com 
Dr O P Singh MD  NRS Medical college and Hospital  Dept. of psychiatry, NRS Medical college and Hospital, 138, AJC Bose Road,Kolkata-700014
Kolkata
WEST BENGAL 		 09434013231

opsingh.nm@gmail.com 
DrVijaya Bhaskara Gupta MD  Rajiv Gandhi institute of medical sciences   Rajiv Gandhi institute of medical sciences , Government General hospital, Srikakulam-532001
Srikakulam
ANDHRA PRADESH 		 09440069415

vijayabharatig@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
AMC MET Ethics committee  Submittted/Under Review 
EC-Nirmal  Approved 
IEC-BMCRI  Submittted/Under Review 
IEC-IPGMER  Approved 
IEC-NRS  Approved 
IEC-RIMS  Approved 
Institutional Ethics committee, Apollo Gleneagles Hospital  Submittted/Under Review 
Institutional Ethics committee,King Georges Medical College  Submittted/Under Review 
Mediciti Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, Major Depressive Disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Escitalopram 10mg, 20mg Tablets  Escitalopram 10mg orally once daily for 7 days, followed by 20mg once daily for an additional 7 days, and then increased to 20mg twice daily till 8 weeks. 
Comparator Agent  Placebo 10mg, 20mg, 40mg Tablets  Placebo 10mg orally once daily for 7 days, followed by 20mg once daily for an additional 7 days, and then increased to 40mg once daily till 8 weeks 
Intervention  Vilazodone 10mg, 20mg & 40mg Tablets  Vilazodone 10mg orally once daily for 7 days, followed by 20mg once daily for an additional 7 days, and then increased to 40mg once daily till 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Patients must be able to provide written informed consent to participate before beginning any trial related activities.
• Male or female outpatients between 18-65 years of age with MDD
• HAM-D-17 score ≥20
• Patients must have general ocular health
• Females of child bearing potential with negative pregnancy test and using double barrier contraceptive measures
. A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR with a current major depressive episode of less than two years duration with a minimum duration of at least four weeks. 
 
ExclusionCriteria 
Details  • HAM-D-17 score decreased by ≥25% between screening and baseline
• Actively suicidal or likely to require hospitalization during the trial
• Electroconvulsive Therapy within six months of screening
• Patients requiring other psychotropic medications and central nervous system active drugs
• Patients with clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic or pulmonary disease
• Patients taking migraine medications with a serotonergic mechanism of action or NSAIDS or drugs that effect coagulation
• Patients taking CYP3A4 inhibitors/inducers, and monoamine oxidase (MAO) inhibitors (or within 14 days of stopping MAO inhibitors)
• Patients with a known hypersensitivity to SSRIs or 5-HT1a agonists
• Patients with symptomatic hyponatremia
• Patients previously treated with vilazodone
• Patients with a history of seizure disorders
• Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post-menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial
• Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
• Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.
• Patients previously unresponsive to SSRIs
• Serious psychiatric co-morbidity (as per investigator’s discretion); although generalized anxiety disorder (GAD), social phobia, simple phobia were permitted
• A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes)
• History of inadequate response to 2 consecutive antidepressants
• DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to screening visit or substance dependence within 6 months prior to the screening visit
• Serious medical co-morbidity
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Change from baseline to week 8 in the Hamilton Rating Scale for Depression (HAM-D-17) total score  Change from baseline to week 8  
 
Secondary Outcome  
Outcome  TimePoints 
MADRS (Montgomery-Asberg Depression Rating Scale) total score, HAM-A total score, CGI-S total score, Sheehan disability scale
Safety End Points 		 baseline to week 8 
 
Target Sample Size   Total Sample Size="375"
Sample Size from India="375" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/11/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of Vilazodone product (Hetero) and Reference product (Escitalopram) in patients diagnosed with major depressive disorder.  The primary objective is to assess the efficacy and safety of vilazodone (40mg/day) administered to adult patients with a major depressive disorder, as measured by mean change from baseline in the Hamilton Rating Scale for Depression (HAM-D-17), at week 8 or end of treatment visits

The secondary objectives are to assess the efficacy of vilazodone (40mg/day) by using secondary measures of depression, anxiety, and overall clinical impression using the Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HAM-A), and Clinical Global Impression Severity (CGI-S), and Sheehan disability scale and to assess the safety profile of vilazodone.

 
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