| CTRI Number |
CTRI/2010/091/001410 [Registered on: 18/11/2010] |
| 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, Multiple Arm Trial |
|
Public Title of Study
|
A study to asses the efficacy and safety of TC-5214 as an adjunct therapy in patients with major depressive disorder. |
Scientific Title of Study
Modification(s)
|
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D4130C00004 |
Protocol Number |
| NCT01153347 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Kapil Dev Jhawar |
| Designation |
Senior Clinical Project Manager |
| Affiliation |
Quintiles Research (India) Pvt Ltd |
| Address |
Quintiles Research (India) Pvt Ltd.
B-101-106,Shapath IV, Opp: Karnavati Club
Ahmadabad
GUJARAT
380051
India |
| Phone |
917966303319 |
| Fax |
917966303366 |
| Email |
Kapil.jhawar@quintiles.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sangamitra Patnaik |
| Designation |
MD |
| Affiliation |
Quintiles Research (India) Pvt Ltd |
| Address |
B-101-106, Opp.Karnavati Club
Shapath IV, Gandhinagar Road
Not Applicable
N/A
380051
India |
| Phone |
07966303340 |
| Fax |
07966527272 |
| Email |
Sanghamitra.patnaik@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suneela Thatte |
| Designation |
|
| Affiliation |
Quintiles Research (India) Pvt Ltd |
| Address |
B-101-106, Opp.Karnavati Club
Shapath IV, Gandhinagar Road
Not Applicable
N/A
38051
India |
| Phone |
912266774242 |
| Fax |
912266774343 |
| Email |
Suneela.thatte@quintiles.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca AB
S-151 85 Södertälje, Sweden
|
|
Primary Sponsor
Modification(s)
|
| Name |
AstraZeneca |
| Address |
Södertälje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Quintiles Research (India) Pvt Ltd. B-101-106, Shapath IV Opp. Karnavati Club, Sarkhej-Gandhinagar, Ahmedabad:380051 India |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 24 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. A. Jagadish |
Abhaya Hospital |
No. 17, Dr. M. H. Marigowda Road,Wilson Garden-560 027
Bangalore
KARNATAKA |
080-26564586 / 09844059066
080-26563865
a_jagadish@yahoo.com |
| Dr. Rohan Kusumgar |
Ashray Clinic |
114, Span Trade Centre,Opposite Koshrab Ashram, Near Paldi Cross -
|
079-26577914
079-26577914
dr_rohan291@rediffmail.com |
| Dr. Ramand SathyPathy |
Brain Mind Behaviour Neurosciences Research Institute |
201, MVV Chambers, OPP KG Hospital,Maharanipeta-530 002
Visakhapatnam
ANDHRA PRADESH |
|
| Dr. Sandeep Shah |
Brij Psychiatry Hospital & Muskaan Research Centre |
Opp. Nimbalkar Chambers,Dandia Bazar-390 001
Vadodara
GUJARAT |
+91-9824060683
0 265-2411621
brijclinic@hotmail.com |
| Dr. Bandna Gupra |
CSM University UP |
Dept of Psychiatry,-
Lucknow
UTTAR PRADESH |
|
| Dr. Venu Gopal Jhanwar |
Deva Mental Health Care |
B,27/70,MN,Badhal, Kothi-221005
|
+91 9936611111
0542- 2310510
venugj@gmail.com |
| 1) Dr. Nadukuru N. Raju |
Government Hospital For Mental Care |
Chinawaltair,Vishakapatnam-530017
|
+91 9849111505
+91-891-2724348
drnnraju@yahoo.com |
| Dr. Keshava Pai Kota |
KMC Hospital |
Department of Psychiatry,Attavar-575001
Bangalore
KARNATAKA |
0824-2445858 / 09448105227
0824-2425092
dockp06@hotmail.com |
| Dr. Ramnathan Sathianathan |
Madras Medical College & Government General Hospital |
Chennai ,-600 003
|
+91 9841019910
+91 91-44-25388989
sathianathen6@yahoo.com |
| Dr. RKMahendru |
Mahendru Psychiatric Centre |
117/40,Sarvodaya Nagar,-208005
|
|
| Dr. Anil Kumar Tambi |
Mental Health Care & Research |
A-500 Govind Marg,Malviya Nagar-302017
Jaipur
RAJASTHAN |
|
| Dr. Mahesh Chudgar |
Mental Illness Treatment Rehabilitation Foundation (MITR) |
1, Shantinagar Society, Way of Azad Sweet,Ashram Road-380 013
Ahmadabad
GUJARAT |
+91 9825412109
079 27552623
mahesh_mitr@yahoo.co.in |
| Dr. Darmavaram Ramacharlu Vijayakumar |
MS Ramaiah Memorial Hospital Dept of Psychiatry |
MSRIT Post,New BEL Road-560054
Bangalore
KARNATAKA |
|
| Dr.Vijayakumar A Nagecha |
Nagecha Hospital |
Creative Chamber,Kanak Rd,Behind bus stand-36002
|
|
| Dr. Kiran Kumar PK |
Opp Highland Hospital, |
Adhit Kiran Neuropsychiatry Centre,-575 002
Bangalore
KARNATAKA |
|
| Dr. Dattatreya Dhavale |
Poona Hospital & Research Centre |
27,Sadashiv Peth-411030
Pune
MAHARASHTRA |
+91 9822028286
020-24337777
dattatreyad@yahoo.com |
| Dr. Kaustubh Joag |
Ruby Hall Clinic |
Consultant Psychiatrist,-411001
Pune
MAHARASHTRA |
|
| Dr. Vinay Barhale |
Shanti Nursing Home / SPUR |
Kanchanwadi,Paithan Road-431005
|
91-9860798041/ 91-240-2376271
91-240-2377631
vinay.barhale@rediffmail.com |
| Dr. Vaishal N Vora |
SNEH Clinic |
301-2-3 Nakshtra Complex,Above HDFC Bank-380008
|
|
| Dr. Mahesh Gowda |
Spandana Nursing Home |
549/46, 6th Main,4th Block, Rajajinagar-560 010
Bangalore
KARNATAKA |
+91 9845134915
080 23141028
maheshrgowda@yahoo.com |
| Dr. Bakul Buch |
Sri Hatkesh Health Foundation |
Opp. Buthnath temple,M G Road-362 001
Junagadh
GUJARAT |
+91 9825220330
0285-2627311
bakulbuch@gmail.com |
| Dr. Umesh Nagapurkar |
Sujata Birla Hospital and Medical Research Center |
Nashik Rd,-
Nashik
MAHARASHTRA |
|
| Dr. Ravish Thunga |
Thunga Institute of Psychiatry & Counseling |
Jyothi Circle,Balmatta-575001
Bangalore
KARNATAKA |
|
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health and Neurosciences (VIMHANS) Hospital |
V.V. Rao Street,Surya Rao Pet-520002
|
91- 9704755669/ 91- 0866 2432040/
91- 0866 2444999
vishalindla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 27 |
| Name of Committee |
Approval Status |
| ABHAYA Ethics Committee, ABHAYA Hospital |
Approved |
| DMHC Ethics Committee |
Approved |
| Ethics Committee MITR Foundation |
Approved |
| Ethics Committee-Shanti Nursing Home |
Approved |
| Independent Ethics Committee 57, Ahmedabad |
Approved |
| Independent Ethics Committee G-10 |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, Andhra Medical College |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Kasturba Hospital Ethics Committee |
Approved |
| Kasturba Medical College-Mangalore |
Approved |
| Lucknow Ethics Committee |
Approved |
| MAANAV Health Foundation Independent Ethics Committee |
Approved |
| Madras Medical College and Government General Hospital |
Approved |
| Mahendru Psychiatric Centre Ethics Committee |
Approved |
| Mallikata Ethical Committee |
Approved |
| MS Ramala Medical College Ethical Review Board |
Approved |
| Norms Ethical Committee |
Approved |
| North Maharashtra |
Approved |
| Poona Hospital and Research Centre |
Approved |
| Poona Medical Research Foundation |
Approved |
| Safe Search Independent Ethics Committee |
Approved |
| Shashvat- Gaurav Accident Fracture Hospital |
Approved |
| Sheth Vadilal Sarabhai General Hospital Ethical Committee |
Approved |
| Spandana Ethics Committee |
Approved |
| The Ethics Committee R.K. Yadav Memorial Hospital |
Approved |
| Vijayawada Institute of Mental Health & Neuro Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Major Depressive Disorder, MDD, Depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Tablet, oral, twice daily for 8 weeks |
| Intervention |
TC-5214 |
Tablet, oral, twice daily for 8 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Provision of signed and dated informed consent before initiation of any study-related procedures.
- The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
- Outpatient status at enrollment and randomization. |
|
| ExclusionCriteria |
| Details |
- Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
- Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a signficant history of risk of suicide or homicide.
- History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16) |
Will be scored at Weeks 8 (baseline), 9, 10, 12, 14, and 16 |
|
|
Secondary Outcome
|
| 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 |
| AEs, SAEs, change in physical exam results and vital signs, laboratory tests and ECG, C-SSRS, BARS and AIMS, CSFQ, and DESS will be assessed as a measure of safety and tolerability |
Will be collected during the whole study period. Unsolicited SAEs will be collected for 30 days post last study treatment |
|
Target Sample Size
Modification(s)
|
Total Sample Size="2236"
Sample Size from India="530"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/06/2010 |
| 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
|
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
|
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 planned date of enrollment for India is 14MAY11 and they are expected to enroll 530 subjects.
|