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
|
|
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)
|
|
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. |