| CTRI Number |
CTRI/2009/091/000129 [Registered on: 06/04/2009] |
| Last Modified On: |
26/10/2012 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Desvenlafaxine succinate ER tablet in the Management of Major Depressive Disorder |
Scientific Title of Study
Modification(s)
|
A Prospective, Open label, Randomized, Comparative, Multicentric trial to evaluate the Efficacy and Safety of Desvenlafaxine succinate ER tablet in the Management of Major Depressive Disorder |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EPL/DVS/2007/01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Abhay Paliwal |
| Designation |
|
| Affiliation |
|
| Address |
2-A, Kailash Park Pragati Apartment, Gita Bhavan
Indore
MADHYA PRADESH
452001
India |
| Phone |
09826044402 |
| Fax |
|
| Email |
abhaypaliwal@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Onkar Swami |
| Designation |
|
| Affiliation |
Manager- Medical |
| Address |
Emcure Pharmaceuticals Ltd.
Phase I, MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821000 |
| Fax |
02039821019 |
| Email |
Onkar.Swami@emcure.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Onkar Swami |
| Designation |
|
| Affiliation |
|
| Address |
Emcure Pharmaceuticals Ltd.
Phase I, MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821000 |
| Fax |
02039821019 |
| Email |
Onkar.Swami@emcure.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Emcure Pharmaceuticals Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Emcure Pharmaceuticals Limited Pune |
| Address |
Survey No. 255/2, Phase I, Hinjwadi MIDC,
Pune-411 057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Paliwal |
Dr. Abhay Paliwal |
2-A, Kailash Park,Pragati Apartment, Gita Bhavan-452001
Indore
MADHYA PRADESH |
09826044402
abhaypaliwal@yahoo.com |
| Dr. Hemang Desai |
Dr. Hemang Desai |
306, Sangini Complex,Near Doctor House, Ellis Bridge-380006
Ahmadabad
GUJARAT |
07926465722
niyatide@wilnetonline.net |
| Dr. Sanjay Phadke |
Dr. Sanjay Phadke |
901, A.J. Arcade,Opposite Ashish Garden, D.P. Road, Kothrud-411038
Pune
MAHARASHTRA |
09823262786
None |
| Dr. Ujwal Sardesai |
Dr. Ujwal Sardesai |
Samvedana, 312,Starlet Corner, Y. N. Road-425006
Indore
MADHYA PRADESH |
09827012336
None |
| Dr. Umesh Nagapurkar |
Dr. Umesh Nagapurkar |
Malpani PRide, Behind Raymond Showroom,Sharanpur Road-422002
|
09823746088
None |
| Dr Karthik Rao |
Healthy Mind Clinic |
Samudra Darshan Society, D.N. Nagar, Andheri(W),-400056
Mumbai
MAHARASHTRA |
|
| Dr Kausar Abbasi |
Jeswani Hospital |
Gandhibag,Parekh Cenre-
Nagpur
MAHARASHTRA |
09823094522
|
| Dr Dinesh Tembe |
Manovedh Clinic |
119, Niranjan Budhwar peth, Station road,-415110
|
|
| Dr. Saoji Sanjeev G. |
Saoji-Tupkari Hospital |
4,Vijay Nagar, Opp Jawhar nagar Police Station,Garkheda Road-431001
Aurangabad
BIHAR |
0240-2451440
|
| Dr. Vinay L. Barhale |
Shanti Nursing Home |
Kanchanwadi,Paithan Road-431005
Aurangabad
BIHAR |
|
| Dr. Arun V. Marwale |
Sharadha Nursing Home |
Sharadha Nursing Home,10-B, Samata Nagar, Opposite Brotherhood Church-431001
Aurangabad
BIHAR |
09422472725
None |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Chinmay Medical Foundation Ethics Committee For Dr. Hemang Desai |
Approved |
| DHR Ethics Committee for Dr Sanjeev Saoji |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Abhay Paliwal |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Arun Marwale |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Dinesh Tembe |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Karthik Rao |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Kausar Abbasi |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Sanjay Phadke |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Ujwal Sardesai |
Approved |
| Ethical Committee Kotbagi Hospital for Dr Umesh Nagapurkar |
Approved |
| Shanti Nursing Home Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Major Depressive Disorder, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Desvenlafaxine succinate |
Desvenlafaxine succinate extended release (ER) available as 50 mg and 100 mg tablets for oral administration. Dose- The starting dose will be 50 mg once daily. If the patient does not improve in depression scores in the first 2 weeks, the dose will be increased to 100 mg once daily in case the need arises. Total duration of therapy will be 60 days followed by 2 weeks of taper period. |
| Comparator Agent |
Venlafaxine hydrochloride |
Venlafaxine hydrochloride extended release (ER) available as 75 mg and 150 mg capsules for oral administration. Dose- The starting dose will be 75 mg once daily. If the patient does not improve in depression scores in the first 2 weeks, the dose will be increased to 150 mg once daily. Total duration of therapy will be 60 days followed by 2 weeks of taper period. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Subject of either sex and age between 18-65 years
2. Subject with Major Depressive Disorder of at least 4 weeks' duration
3. Subject with Hamilton rating score for depression more then 17
|
|
| ExclusionCriteria |
| Details |
1. Patient with features of psychosis
2. Subjects with bipolar disorder
3. Concomitant use of other antidepressants
4. Endocrine disease other than Type 2 diabetes
5. Hypersensitivity to Venlafaxine or Desvenlafaxine
6. History of arrhythmias
7. History of congestive heart failure
8. History of coronary artery disease
9. History of stroke
10. Severe hypertension
11. Liver impairment
12. Narrow angle glaucoma
13. Untreated hypothyroidism or hyperthyroidism
14. Pulmonary hypertension
15. Renal impairment
16. History of seizures
17. Alcohol abuse
18. Psychoactive substance abuse
19. Recent tobacco cessation
20. Lactating or pregnant women
21. Any condition that, in the opinion of the investigator, does not justify the subjects? inclusion in the study
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in depression as assessed by the change in Hamilton Rating Scale for Depression (HAM-D) from the baseline till the end of 2 months. |
0,15,30,45,60 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in depression as assessed by the change in Montgomery-Asberg Depression rating Scale (MADRS) from the baseline till the end of 2 months. |
0,15,30,45,60 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="0"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/04/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, randomized, open-label, multi-centric, comparative clinical trial being conducted to evaluate the efficacy, safety and tolerability of Desvenlafaxine succinate extended release (ER) tablet and its comparison with Venlafaxine hydrochloride extended release (ER) in the management of Major Depressive Disorder (MDD). Total 200 patients (100 per group) will be enrolled in this study. Study population will comprise of subjects with moderate and severe depression with Hamilton Rating Scale for Depression (HAM-D) of more than 17; routinely visiting clinics / hospitals of the investigators at the trial sites for management of the same. The starting dose of Desvenlafaxine succinate ER will be 50 mg once daily. If the patient does not improve in depression scores in the first 2 weeks, the dose will be increased to 100 mg once daily in case the need arises. The starting dose of Venlafaxine hydrochloride ER will be 75 mg once daily. If the patient does not improve in depression scores in the first 2 weeks, the dose will be increased to 150 mg once daily. Duration of therapy will be for minimum 60 days followed by 2 weeks of taper period. Primary efficacy outcome will be improvement in depression as assessed by the change in Hamilton Rating Scale for Depression (HAM-D) from the baseline till the end of 2 months. Secondary efficacy outcome will be improvement in depression as assessed by the change in Montgomery-Asberg Depression rating Scale (MADRS) from the baseline till the end of 2 months. |