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CTRI Number  CTRI/2020/07/026583 [Registered on: 15/07/2020] 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   An Open Label, Multicentre Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice 
Scientific Title of Study   An open Label,multicentre Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg 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  Ishwar Institute of Health Care. Ishwar Heights, Plot no 7, gut no 6/1, Beside Punjabi Bhawan, Padegaon, Aurangabad.
Ishwar Institute of Health Care. Ishwar Heights, Plot no 7, gut no 6/1, Beside Punjabi Bhawan, Padegaon,
Aurangabad
MAHARASHTRA
431002
India 
Phone  9823860018  
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  04423780116   
Fax    
Email  yogesh@iddresearch.com  
 
Details of Contact Person
Public Query
 
Name  MrVairamuthuAmmaiyappam 
Designation  Associate Director 
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  vairamuthu.ammaiyappan@iddresearch.com  
 
Source of Monetary or Material Support  
Ishwar institute of Healthcare udayaan Healthcare Medstar Speciality hospital 
 
Primary Sponsor  
Name  Macsur Pharmaa I Pvt Ltd  
Address  Macsur Pharmaa (I) Pvt. Ltd., 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   : Ishwar Institute of Health Care. Ishwar Heights, Plot no 7, gut no 6/1, Beside Punjabi Bhawan, Padegaon, Aurangabad
Aurangabad
MAHARASHTRA 
9823860018

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

medstarhospitalcr.crc1@gmail.com 
Dr Mukulesh Gupta  Udyaan Healthcare  Udyaan Health care, 730 Udyan-1, Eldeco,Opposite AWHO Colony ,Near Bangla Bazar
Lucknow
UTTAR PRADESH 
9336046146

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
Modification(s)  
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  Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg   The investigational drug is a fixed dose Amitriptyline and Chlordiazepoxide.This product contains 2 medicines (amitriptyline, chlordiazepoxide) and is used to treat mental/mood disorders such as depression with symptoms of anxiety. Amitriptyline belongs to a class of medications called tricyclic antidepressants. It may help improve mood and feelings of well-being, relieve anxiety and tension, and help you sleep better. It works by affecting the balance of certain natural chemicals (neurotransmitters such as serotonin) in the brain. Chlordiazepoxide helps to reduce anxiety. It acts on the brain and nerves to produce a calming effect. It belongs to a class of drugs known as benzodiazepines. Route of Administration -Oral 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. Naïve 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. Newly prescribed with Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg as per the investigators discretion.  
 
ExclusionCriteria 
Details  1. Hypersensitivity to Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg 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 Amitriptyline or Chlordiazepoxide.
4. any other treatments such as SSRIs, other antidepressants, thienodiazepines, benzodiazepines, barbiturates, or β-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
5. any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions.
6. A history of drug or alcohol abuse within the past 6 months.
7. Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study.
8. 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 Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in patients with major depressive disorder associated with anxiety in regular clinical practice.  To demonstrate the safety and efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in patients with major depressive disorder. Screening/Baseline visit on Day 1,
telephonic visit (Week 4)
End of study Visit (EOS) at Week 8 
 
Secondary Outcome  
Outcome  TimePoints 
"To demonstrate the efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in patients with major depressive disorder associated with anxiety in regular clinical practice"  1.The primary efficacy is evaluated by using Montgomery-Ã…sberg Depression Rating Scale (MADRS) at Week 8.

2.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)   15/07/2020 
Date of Study Completion (India) 14/10/2020 
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 of Study: An Open Label, Multicentre, Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice 

Name of Study Therapy: Major Depressive Disorder with Associated Anxiety

Study Rationale: This study is designed to assess the safety and efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in subjects with major depressive disorder associated with anxiety. The study was conducted to meet a regulatory requirement of Central Drugs Standard Control Organisation (CDSCO) in India for market authorization. 

Study design: This will be an open-label, multi-center, post-marketing surveillance study to evaluate the newly prescribed safety and efficacy of fixed dose combination (FDC) of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in subjects with major depressive disorder with associated anxiety. A total of approximately 200 male and female subjects will be enrolled in 4 centers in India.  For each enrolled subject, there will be a 1-day Screening/Baseline visit on Day 1, followed by a telephonic visit (Week 4) and End of study Visit (EOS) at Week 8. On the Day of Screening/Baseline, the medical history will be reviewed and study eligibility according to the inclusion and exclusion criteria will be confirmed. Eligible subjects will receive the combination therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg once a day, on Day 1 (Baseline visit), at their investigator’s discretion. Following a single oral dose of combination of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg, safety and efficacy assessments will be performed and data will be collected at the clinic visits. Subjects are followed up by their investigator during the telephonic visit at Week 4 and at the EOS (Week 8) to collect the subject data 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). ECG details (if done) by investigator will be recorded in CRF. Safety assessments will include adverse event, serious adverse event monitoring and physical examinations. 
 
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