| CTRI Number |
CTRI/2021/03/031971 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Post marketing study to see safety and efficacy of combination of Amitriptyline and Chlordiazepoxide in management of depression with co-morbid anxiety |
|
Scientific Title of Study
|
A Prospective, single arm, Multi-centric, Active, Post Marketing Surveillance Study for evaluation of safety and efficacy of FDC of Amitriptyline and Chlordiazepoxide tablets of Dr. Reddys Laboratories Ltd in management of depression with co-morbid anxiety |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GGI-Libotryp-07-2020 version 2 date 06 Aug 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Bhagat |
| Designation |
Clinical Research Specialist |
| Affiliation |
Clinical Research Specialist |
| Address |
Dr Reddys Laboratories Limited
8-2-337 Road No. 3
Banjara Hills Hyderabad
Telangana 500034 INDIA
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
seemavikasb@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amey Mane |
| Designation |
Head Ideation and Clinical Research |
| Affiliation |
Head Ideation and Clinical Research |
| Address |
Dr Reddys Laboratories Limited
8-2-337 Road No. 3
Banjara Hills Hyderabad
Telangana 500034 INDIA
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
amey.mane@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Amey Mane |
| Designation |
Head Ideation and Clinical Research |
| Affiliation |
Head Ideation and Clinical Research |
| Address |
Dr Reddys Laboratories Limited
8-2-337 Road No. 3
Banjara Hills Hyderabad
Telangana 500034 INDIA
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
amey.mane@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories limited |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Ltd
8-2-337 Road Number 3
Banjara Hills Hyderabad
Telangana 500034 INDIA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Umesh Nagapurkar |
Chopda Medicare and Research Centre Pvt limited Magnum Heart institute |
Chopda Medicate & Research Centre Pvt Ltd Magnum Heart Institute 3/5 Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya Canada Corner Nashik 422005 Maharashtra India
Nashik
MAHARASHTRA |
9823146088
umeshanjali@gmail.com |
| Dr Archana Javdekar |
Dr D Y Patil Medical College hospital and research centre |
Department of Psychiatry Dr D Y Patil Medical college hospital and research centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
9822041271
archanajavdekar@gmail.com |
| Satheesh Rao |
K.S. Hegde Medical Academy |
KS Hegde Medical Academy
KS Hegde Medical Sciences Complex Department of Psychiatry Deralakatte Mangaluru 575 018 Karnataka INDIA
Dakshina Kannada
KARNATAKA |
8242203044
dr_satheeshrao@yahoo.com |
| Dr Singaravelu Thiyagarajan |
Life Care Clinic |
Life Care Clinic 43 - A Paul Street Fort Salem 1 Tamil Nadu
Salem
TAMIL NADU |
9080506147
singaravelu@hotmail.co.uk |
| Dr Heena Merchant |
Lokmanya Tilak Muncipal Medical college and general hospital |
Lokmanya Tilak Municipal Medical College and General Hospital, Dr. Babasaheb Ambedkar Road,
Sion (West), Mumbai – 400022
Maharashtra, India
Mumbai
MAHARASHTRA |
7977739233
heenathedoc@gmail.com |
| Dr Nischol Raval |
Sahyadri Super specialty hospital |
Sahyadri Super specialty hospital, ​Plot no.30 – C, Erandwane, Deccan Gymkhana, Pune 411004, Maharashtra, India
Pune
MAHARASHTRA |
9689490033
nischolraval@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics committee - Dr D Y Patil Vidyapeeth, Pune |
Approved |
| Human Research Lokmanya Tilak Municipal medical College IEC HR Ltmmc |
Submittted/Under Review |
| MagnaCare Ethics Committee |
Approved |
| Nitte Deemed to be University University Enclave Medical Sciences Complex Deralakatte mangalore Dakshina Kannada Karnataka |
Approved |
| Sahyadri Clinical Research & Development Center |
Approved |
| Shanmuga Medical Research Foundation Trust No.24 Saradha College road Salem Salem Tamil Nadu 636007 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Libotryp tablets and Libotryp DS tablets |
Combination of Amitriptyline 12.5 mg or 25mg and Chlordiazepoxide 5 mg or 10 mg
Chlordiazepoxide and amitriptyline hydrochloride tablets 10 mg or 5 mg and 25mg or 12.5 mg in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients or as per investigator descretion
The total duration is 2 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient with anxiety comorbid with depression
Newly Prescribed with Libotryp or Libotryp DS as per clinical discretion of investigator
|
|
| ExclusionCriteria |
| Details |
Patients who is not able to understand the nature of study and willing to provide written informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To actively surveil safety of FDC of Amitriptyline and Chlordiazepoxide tablets in management of depression with co-morbid anxiety in India in terms of Sedative effects and Anticholinergic side effects and Dizziness and Decrease in Libido |
Incidence of any of the following event
Sedative effects or Anticholinergic side effects
or Dizziness or Decrease in Libido or AE or SAE at Day 30 and Day 60 after study using study medication
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To passively evaluate Safety reports such as adverse drug reactions, laboratory parameters, ECG (if available)
To evaluate Efficacy as change in Hamilton Anxiety Score (HAM-A) and Hamilton Depression Score (HAM-D) score
|
Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 30 days of therapy
2. Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 60 days of therapy
|
|
|
Target Sample Size
|
Total Sample Size="375"
Sample Size from India="375"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/03/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This multicentric single arm post marketing surveillance study would be performed in patients of anxiety comorbid with depression, who have been newly prescribed FDC of Amitriptyline and Chlordiazepoxide tablets of Dr. Reddy’s Laboratories Ltd. All the enrolled patients will be followed up for 60 day and will be assessed for HAM-A and HAM-D assessment. Patients will be encouraged to report adverse events throughout the study period. All the data generated will be analysed using appropriate statistical test. |