FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/026974 [Registered on: 04/08/2020] Trial Registered Prospectively
Last Modified On: 17/02/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated Anxiety 
Scientific Title of Study   An Open Label, Multicentre, Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amol Deshmukh 
Designation  principle investigator 
Affiliation  Ishwar Institute of Health Care 
Address  3d Floor, Plot No. 7, Gate No. 6/1, Padhegaon Beside Panjabi Bhavan, Jaysingpura, Aurangabad Maharashtra, India

Aurangabad
MAHARASHTRA
431002
India 
Phone  7057418854  
Fax    
Email  ishwarhealthcare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh sharma 
Designation  Medical officer 
Affiliation  iDD Research Solutions Pvt ltd 
Address  4th Floor, Ektha Serene, Located at 103/H | G-B & 104 / HIG-B Survey, No.132, Gachibowli Housing Board Colony, Gachibowli, Hyderabad

Hyderabad
TELANGANA
500 095
India 
Phone  8520082152  
Fax    
Email  yogesh@iddresearch.com  
 
Details of Contact Person
Public Query  
Name  MrVairamuthuAmmaiyappam 
Designation  Associate Direstor 
Affiliation  iDD Research Solutions Pvt ltd 
Address  4th Floor, Ektha Serene, Located at 103/H | G-B & 104 / HIG-B Survey, No.132, Gachibowli Housing Board Colony,Gachibowli, Hyderabad,Telangana-500 095

Hyderabad
TELANGANA
500 095
India 
Phone  8520082152  
Fax    
Email  vairamuthu.ammaiyappan@iddresearch.com  
 
Source of Monetary or Material Support  
Udyaan Health care 
Ishwar Institute of Health Science  
Medstar Speciality Hospital 
 
Primary Sponsor  
Name  Macsur Pharmaa I Pvt Ltd 
Address  Othiyampet, Villianur Commune, Puducherry 605 110 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amol Deshmukh  Ishwar Institute of Health Science Padegaon   3d Floor, Plot No. 7,Gate No.6/1, Padhegaon Beside Panjabi Bhavan, Jaysingpura Aurangabad
Aurangabad
MAHARASHTRA 		 7057418854

ishwarhealthcare@gmail.com 
DrSharanabasappa Ambarao  Medstar Speciality Hospital  #641/17/1/3, kodigehalli main road,sahakar nagar,
Bangalore
KARNATAKA 		 8248599949

medstarhospitalcr.crc1@gmail.com 
Dr Mukulesh Gupta  Udyaan Health care,  Udyaan Health care, 730 Udyan-1, Eldeco,Opposite AWHO Colony ,Near Bangla Bazar,
Lucknow
UTTAR PRADESH 		 7317445133

udyaan.iec@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ishwar Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
MedstarSpecialityHospitalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Escitalopram 5 mg/10 mg and Etizolam 0.5 mg  Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI). It may improve your energy level and feelings of well-being and decrease nervousness Route of Administration oral and duration 8 weeks 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Willing and able to sign informed consent form. Written informed consent must be obtained before any assessment is performed
2. Male and female subjects of aged 18 years to 75 years
3. Patients suffering from MDD with associated anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
4. Patients who are previously on SSRIs anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
ï‚· Patients who are previously on SSRIs 
 
ExclusionCriteria 
Details  1. Hypersensitivity to Escitalopram 5 mg/10 mg and Etizolam 0.5 mg or any excipients
2. Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments.
3. Known contraindication for the use of Escitalopram or Etizolam
4. Patients with serotonin syndrome
5. Should not be SSRI resistant (not responding to 4-6 weeks of SSRI previously)
6. Any other treatments such as fluoxetine (SSRI), other antidepressants, hienodiazepine, benzodiazepines, barbiturates, or β-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
7. Any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions.
8. A history of drug or alcohol abuse within the past 6 months
9. Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study
10. Female who is pregnant, nursing, or of child-bearing potential.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the safety and efficacy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder associated with anxiety in regular clinical practice   Day 1 : Screening/ Baseline Visit.
Week 4 : Telephonic Visit.
Week 8 : End of study. Data collection. 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate the efficacy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder associated with anxiety in regular clinical practice  The primary efficacy is evaluated by using Montgomery-Ã…sberg Depression Rating Scale (MADRS) at Week 8 and ï‚· The secondary efficacy is evaluated by using Hamilton Depression Rating Scale17 (HAMD-17) at Week 8.  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   14/08/2020 
Date of Study Completion (India) 12/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Publication of the results of the study wether in whole or in part, shall be within the sole and absolute discreation of the sponsor. The contractor shall not be entitled to pubish any of the data or information arising during or out of the provision of the services without the prior written consent of the Sponsor. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Title :  An Open Label, Multicentre, Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice.

Study Rationale : The purpose of this study is to collect clinical data, mainly focusing on safety, in the local target population (200 eligible subjects) with major depressive disorder (MDD) associated with anxiety, to meet a regulatory requirement of Central Drugs Standard Control Organisation (CDSCO) in India for market authorization.

Design and Investigational Plan :  This is an open-label, post-marketing study to evaluate safety and efficacy on administration of fixed dose combination (FDC) of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder with associated anxiety. The total study duration will be approximately 8 weeks. The trial will consist of a wash-out period of 7-10 days, a 1-day Screening/Baseline visit on Day 1 (Visit 1), followed by telephonic visit at Week 4 (Visit 2) and End of study Visit (Week 8). All subjects will be prescribed Escitalopram 5 mg/10 mg and Etizolam 0.5 mg once a day, orally at Baseline (Visit 1) at their investigator’s discretion. During the treatment period, subject data will be collected at telephonic visit and at EOS at the clinic visits. Subjects are followed up by their investigator according to clinical need. Subjects will be instructed to report any adverse events (AE)/serious adverse event (SAE) within the course of the study. Data in a routine clinical monitoring of subjects are collected in the paper case report form (CRF). 

Data Analysis Methods : No statistical hypothesis testing will be done and data will be presented using descriptive statistics. Continuous data will be presented by using summary statistics such as mean, median, standard deviation, minimum and maximum. Categorical data will be presented with counts and percentages. For each individual AEs will be coded by using world health organization adverse reaction terminology (WHOART) according to the local regulation. 


 
Close