| CTRI Number |
CTRI/2017/11/010324 [Registered on: 01/11/2017] Trial Registered Prospectively |
| Last Modified On: |
17/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on combination of two drugs in the treatment of depression with anxiety |
|
Scientific Title of Study
|
A Prospective, randomized, active-controlled, Comparative, Open-Label, parallel group, 2-arm, Multi-centric, Phase IV trial for evaluation of efficacy and safety of FDC of Amitriptyline and Chlordiazepoxide tablets of Wockhardt Limited versus Amitriptyline alone in management of depression with co-morbid anxiety. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WOC/LIB/CT-54/15 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Agam Shah |
| Designation |
Head, Clinical Operations, India & Emerging Markets |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Ltd, Wockhardt towers, Bandra Kurla complex, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596762 |
| Fax |
|
| Email |
AShah@wockhardt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Katare |
| Designation |
Manager, Medical Affairs. |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Ltd, Wockhardt towers, Bandra Kurla complex, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596763 |
| Fax |
|
| Email |
SKatare@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish Mane |
| Designation |
Manager, Medical Affairs. |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Ltd, Wockhardt towers, Bandra Kurla complex, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
0222659686 |
| Fax |
|
| Email |
AshishM@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd, Wockhardt Towers, Bandra Kurla Complex, Mumbai 400051 |
|
|
Primary Sponsor
|
| Name |
Wockhardt Ltd |
| Address |
Wockhardt towers, Bandra Kurla complex, Mumbai 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabir Thakuria |
Downtown Hospital |
Department of Psychiatry, 2nd Building , Ground Floor
Downtown hospital, Guwahati Shilong Road.
Guwahati- 781036
Kamrup
ASSAM |
03612331003
thakuriap@gmail.com |
| Dr Manish Jain |
Dr. B.L. Kapur Memorial Hospital |
Department of Psychiatry, Pusa Road, New Delhi-10005.
New Delhi
DELHI |
01130403040
drmanishjain@blkhospital.com |
| Dr Sandeep Jain |
Marudhar Hospital |
Room no 9, General Medicine, A-93-99, Singh bhoomi, Khatipura Road, Jaipur-302012,
Jaipur
RAJASTHAN |
01412356944
drsandeeprjain@yahoo.co.in |
| Dr Om Prakash Singh |
Nilratan Sircar Medical College & Hospital |
Department of Psychiatry, 138,A J C Bose Road, Kolkata 700014
Kolkata
WEST BENGAL |
9434013231
opsingh.nm@gmail.com |
| Dr Sudhish Sehra |
Sri Balaji Action Medical Insitute |
Department of Medicine, A-4, Paschim Vihar, New Delhi, 110063
New Delhi
DELHI |
01142888888
sudhish.sehra@gmail.com |
| Dr Umesh Nagapurkar |
Sujata Birla Hospital and Medical Research Cente |
Department of Psychiatry Sujata Birla Hospital and Medical Research Center, Opp. Bytco College. Nashik. 422201
Nashik
MAHARASHTRA |
02532407700
umeshanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Dr. B.L. Kapur Memorial Hospital Ethics Committee |
Submittted/Under Review |
| Ethics committee down town hospital |
Submittted/Under Review |
| IEC Nilratan Sircar Medical College |
Submittted/Under Review |
| Marudhar Hospital Ethics Committee |
Approved |
| Sri Balaji Action Medical Institute Ethics committee |
Submittted/Under Review |
| Yash Society Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Depression with co-morbid anxiety, (1) ICD-10 Condition: F418||Other specified anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amitriptyline tablets |
10 mg or 25 mg of amitriptyline |
| Intervention |
Libotryp and Libotryp DS tablets |
Libotryp tablets (FDC of
Amitriptyline 12.5 mg and
Chlordiazepoxide 5 mg) and
Libotryp DS tablets (FDC of
Amitriptyline 25 mg and Chlordiazepoxide 10 mg) of
Wockhardt Limited |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subject with all of the following would be included in the study:
1. Patients with clinical diagnosis of depression with co-morbid anxiety (Depression Score: More than or equal to 8 and anxiety Score: 0 – 56) on Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) respectively.
2. Patients or LAR who understand the nature of the trial and provide written informed consent for trial
3. Subjects who are willing to comply with protocol procedures
|
|
| ExclusionCriteria |
| Details |
Subject with any of the following would be excluded from the study:
1. Patients with proven hypersensitivity to any of the contents of study medication i.e. Amitriptyline and Chlordiazepoxide.
2. Patients who, in the investigator’s opinion, pose a risk for suicide/suicidal tendency
3. Patients with history of neuroleptic malignant syndrome due to any tricyclic antidepressants
4. History of any neurological disease including but not limited to stroke, tumor, seizure disorder history of brain trauma, chronic infection or a dementing illness or any psychotic disorder including but not limited to schizophrenia, delusional disorder or organic brain syndrome.
5. Significant Hepatic and/ or Renal insufficiency
6. Patient with known history of or currently suffering from Cardiac arrhythmia or conduction abnormality including but not limited to sinus tachycardia and prolongation of conduction time (Screening QTcB or QTcF > 450 msec).
7. Patient with known history of urinary retention due to organic failure
8. Patient with history of Myocardial Infarction (MI) or is in acute recovery phase of MI.
9. Patient who used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or are expected to need MAOI treatment at any time during this study
10. Patients who have received an antipsychotic or a benzodiazepine for at least 7 days prior to enrolment into the study
11. Pregnant or lactating females.
12. Patients who are alcoholics or having withdrawal symptoms of alcohol
13. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores. |
At end of 45 days of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events (AEs), serious adverse events (SAEs), abnormal laboratory values, Clinical findings |
Throughout the treatment period |
| Mean change in Depression and anxiety scores from baseline using Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) |
At end of 45 days of therapy |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/11/2017 |
| 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) |
Suspended |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amitriptyline and Chlordiazepoxide is proven to be effective in management of depression with co-morbid anxiety.
This study is been designed to evaluate the efficacy and safety of FDC of Amitriptyline and Chlordiazepoxide tablets of Wockhardt limited Versus Amitriptyline alone in management of depression with co-morbid anxiety. |