| CTRI Number |
CTRI/2010/091/001491 [Registered on: 16/11/2010] |
| Last Modified On: |
12/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD) |
Scientific Title of Study
Modification(s)
|
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Therapy |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| D4130C00002 |
Protocol Number |
| NCT01157078 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Hiren Thakkar |
| Designation |
Proj Director |
| Affiliation |
Quintiles |
| Address |
B-101-106,Shappath IV, Opp: Kamavati Club
Sarkhej-Gandhinagar Road
Ahmadabad
GUJARAT
380051
India |
| Phone |
917966303380 |
| Fax |
917966303366 |
| Email |
Hiren.Thakkar@quintiles.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanghamitra Patnaik |
| Designation |
Director Regulatory Affairs |
| Affiliation |
Quintiles Research (India) |
| Address |
B-101-106,Shappath IV,
Opp: Kamavati Club
Sarkhej-Gandhinagar Road
Ahmadabad
GUJARAT
380051
India |
| Phone |
0-79-6630-3340 |
| Fax |
0-79-6652-7272 |
| Email |
Sanghamitra.Patnaik@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suneela Thatte |
| Designation |
Executive Director Clinical Operations |
| Affiliation |
|
| Address |
301-A-1 Leela Business Park
M.V. Road
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-22-6677-4242 |
| Fax |
91-22-6677-4343 |
| Email |
Suneela.Thatte@quintiles.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
AstraZeneca AB |
| Address |
S-151 85 Sodertalje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Pvt Ltd |
B-101-106, Shapath IV Opp.Karnavati Club,Sarkhej- Gandhinagar Road,Ahmedabad: 380051 India |
|
Countries of Recruitment
Modification(s)
|
India
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 12. Dr. Shekhar Aluka Reddy |
ADI Clinics |
Near star hospital, Banjara Hills, Hyderabad-500003
|
+91 9848059452
+9104024050093
drshekarreddy@gmail.com |
| Dr NNRaju |
Government Hospital for Mental Care |
Government Hospital For Mental Care, Chinawaltair, Vishakapatnam 530017, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
919849111505
918912724348
drnraju@yahoo.com |
| DrT S Sathyanarayana Rao |
JSS Medical College and Hospital |
Ramanuja Road,570004
Mysore
KARNATAKA |
919845282399
918212442840
tssrao19@yahoo.com |
| 6. Dr.Ramesh Kumar Mahendru |
Mahendru Psychiatric Centre |
117/40,Sarvodaya Nagar, Kanpur -208005
|
+91 9336124372
+ 915122242034
mahendru.rk@gmail.com |
| 5. Dr. Suresh Kumar Kota |
Poly Clinic And Mental Health Care Centre |
1st Line, Samba-shiva Pet,Guntur -522001
|
+91 9848303169
+ 918632320559
kotasureshkumar99@yahoo.co.in |
| 9. Dr. C. Ramasubramaniam |
Radianz Clinical Research Unit |
No. 662, K.K.Nagar,Madurai -625020
|
+91 9843255444
+ 914522580992
cnucrc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| 10. Ethics Committee, Rogi Kalyan Samiti, Government Medical College and Sir Takhat-Singhji Hospital |
Submittted/Under Review |
| 11. Radix Central Ethics Committee, Manas Hospital, |
Submittted/Under Review |
| 12. Ethics Committee Sravani Poly Clinic and Mental Health Care Centre |
Submittted/Under Review |
| 3. Ethics Committee- JSS Medical College |
Submittted/Under Review |
| 5. Ethics Committee Sravani Poly Clinic and Mental Health Care Centre |
Submittted/Under Review |
| 6. Ethics Committee-Mahendru Psychiatric Centre |
Submittted/Under Review |
| 7. Cosmos Independent Ethics Committee, Shanti Home |
Submittted/Under Review |
| 8. Cosmos Independent Ethics Committee, Delhi Psychiatry Centre |
Submittted/Under Review |
| 9. Ethics Committee, M. S. Chelamuthu Trust and Research Foundation |
Submittted/Under Review |
| Ethics Committee-Poona Hospital and Research Centre |
Approved |
| Ethics Committee-Poona Hospital and Research Centre 27 |
Approved |
| Institutional Ethics Committee, Andhra Medical College |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Reseach Centre |
Approved |
| Sanmathi Central 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 |
| Comparator Agent |
Placebo |
Tablet, oral, BID for 8 weeks |
| Intervention |
TC-5214 |
Tablet, oral, 1, 2 or 4 mg BID |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Provision of signed and dated informed consent before initiation of any study-related procedures.
2.The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
3.Out-patient status at enrollment and randomization. |
|
| ExclusionCriteria |
| Details |
1.Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
2.Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
3.History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from randomization to end of treatment |
Will be scored at weeks 8,9,10,12,14 and 16 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in clinician-rated symptoms as assessed by MADRS, HAM-D, CGI-S, CGI-I and HAM-A |
MADRS and CGI will be scored at Weeks 8 (baseline), 9, 10, 12, 14, and 16; HAM-D and HAM-A will be scored at Weeks 8 (baseline) and 16. |
| Changes in patient-reported outcomes as assessed by SDS, Q-LES-Q-SF, QIDS-SR-16 and SIS |
Will be analysed at Weeks 8, 12 and 16. QIDS-SR-16 will also be measured at Week 10 |
| Safety and tolerability |
Time consent signed (enrollment, 1-2 wk screening/washout period), during 8-wk prospective open-label period, during 8-wk randomized double-blind period, and during 2-wk follow up period. Unsolicited SAEs collected 30 days post last treatment. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="940"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/06/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant. The anticipated number of patients proposed to be recruited from India is 46 and anticipated date of enrollment is 12NOV2010. |