| CTRI Number |
CTRI/2011/10/002065 [Registered on: 14/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
11/04/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder. |
|
Scientific Title of Study
|
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in patients with Major Depressive Disorder with an Inadequate Response to Antidepressant Therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D4131C00001 |
Protocol Number |
| NCT01288079 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KS Veeresh BPharm |
| Designation |
Associate Clinical Team Lead |
| Affiliation |
Quintiles Research (India) Private Limited |
| Address |
4th Floor, Nitesh Time Square
8, M. G. Road
Bangalore 560001, INDIA
Bangalore
KARNATAKA
560001
India |
| Phone |
918066552069 |
| Fax |
918095502193 |
| Email |
veeresh.swamy@quintiles.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
VP Medical |
| Affiliation |
Quintiles Research (India) Pvt Ltd |
| Address |
8th Floor DLF Square, Jacaranda Marg, M Block, DLF Phase II
Gurgaon
Haryana-122002
Kurukshetra
HARYANA
122002
India |
| Phone |
911246755861 |
| Fax |
911246755959 |
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneela Thatte |
| Designation |
Executive Director Clinical Operations |
| Affiliation |
Quintiles Research (India) Pvt. Ltd. |
| Address |
301-A-1 Leela Business Park;
M.V.Road,
Andheri (E),
Mumbai-400059
India
Mumbai
MAHARASHTRA
400059
India |
| Phone |
912266774242 |
| Fax |
912266774343 |
| Email |
Suneela.thatte@quintiles.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca AB
S-151 85 Sodertalje, Sweden
|
|
|
Primary Sponsor
|
| Name |
AstraZeneca AB |
| Address |
S-151 85 Sodertalje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Estonia
Finland
India
Japan
United States of America |
|
Sites of Study
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mahesh Chudgar |
Mental Illness Treatment Rehabilitation Foundation (MITR) |
opp. Sat. laurn hotel, Ashram road - Ahmadabad 380013
Ahmadabad
GUJARAT |
9825412109
mahesh_mitr@yahoo.co.in |
| Anjappa Jagadish |
Abhaya Hospital |
Psychiatry department, No. 17, Dr. M. H. Marigowda Road, Wilson Garden, Bangalore- 560027, Karnataka, India
Bangalore
KARNATAKA |
9844059066
a_jagadish@yahoo.com |
| Sanjay Phadke |
Deenanath Mangeshkar Hospital & Research centre |
Erandawane, Pune - 411 004, Maharashtra, India
Pune
MAHARASHTRA |
9823262786
sanjay_phadke@hotmail.com |
| Venu Gopal Jhanwar |
Deva Institute of Health care & Research Pvt. Ltd |
Deva Institute of Health care & Research Pvt. Ltd, B - 27/70 mn , durgakund, Varanasi, UP - 221005
Varanasi
UTTAR PRADESH |
9936611111
vgjhanwar@devainstitute.com |
| Dr Hitendra Gandhi |
Dr. Hitendra Gandhi |
Room No. 14, Arogya Bhuvan, opp. Psychiatry ward, Sheth V.S. Hospital, Ellisbridge, Ahmedabad - 380006
Ahmadabad
GUJARAT |
9825066769
hitengandhi@yahoo.co.in |
| Nadukuru Nooka Raju |
Government Hospital For Mental Care |
Dr. N N Raju, Department of Psychiatry, Government Hospital For Mental Care, chainna waltair, Visakhapatnam - 5300017
East Kameng
ARUNACHAL PRADESH |
9849111505
drnnraju@yahoo.com |
| R Sathianadhan |
Madras Medical College and Government General Hospital |
Ward 120, Dept of Psychiatry, Madras Medical College and Government General Hospital, Chennai - 6000003, Tamil Nadu, India
Chennai
TAMIL NADU |
9841019910
sathianathen6@yahoo.com |
| RK Mahendru |
Mahendru Psychiatric Centre |
Mahendru Psychiatric Centre, 117/40, Sarvodaya Nagar, Kanpur-208 005
Kanpur Nagar
UTTAR PRADESH |
9336124372
rkmahendru@indiatimes.com |
| Ravish Tunga |
Manaswini, Thunga Institute of Psychiatry and Counselling |
Near Jyoti Circle, Balmatta, Mangalore - 575 001, Karnataka, India
Bangalore
KARNATAKA |
9845263090
ravishthunga@yahoo.com |
| Dr Anil Tambi |
Mental Health care & Research |
Neuropsychiatry clinic, A-500,Govind Marg, Malviya Nagar, Jaipur ,Rajasthan - 302017, India
Jaipur
RAJASTHAN |
9828899902
dr.tambianil@yahoo.co.in |
| Rakesh Yadav |
R. K. Memorial Mental Health and deaddiction Hospital |
B -6, Hanuman Nagar, Sirsi Road, Jaipur - 302021
Jaipur
RAJASTHAN |
9829066418
drrakeshyadav@hotmail.com |
| Mahesh Gowda |
Spandana Nursing Home |
549/46, 6th Main, 4th Block, Rajajinagar, Bangalore – 560 010, Karnataka, India
Bangalore
KARNATAKA |
9845134915
maheshrgowda@yahoo.com |
| Umesh Nagapurkar |
Sujatha Birla Hospital & Medical research centre |
opp. BYTCO college, Nashik road, Nashik, 422101.
Nashik
MAHARASHTRA |
9823146088
umeshanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Abhaya Ethics Committee, Bangalore, Dr. Anjappa Jagdish |
Submittted/Under Review |
| DMHC Ethics Committee, Varanasi, Dr. Venu Gopal Jhanwar |
Approved |
| Ethics Committee Memorial Mental Health and deaddiction Hospital, Jaipur, Dr. Rakesh Yadav |
Submittted/Under Review |
| Indepent Ethics Committee, Jaipur, Dr. Anil Tambi |
Approved |
| Institional Ethics Committee, Pune, Dr. Sanjay Phadke |
Submittted/Under Review |
| Institutional ethics committee, Vishakhapatnam, Dr. Nadukuru Nooka Raju |
Submittted/Under Review |
| Kanpur Medical ethics committee, Kanpur, Dr. R.K. Mahendru |
Approved |
| Malikatta Independent Ethical committee, Mangalore, Dr. Ravish Tunga-Manaswini |
Approved |
| Mitra foundation Ethics Committee, Ahmedabad, Dr. Mahesh Chudgar |
Approved |
| North Maharastra Ethics Committee, Nashik, Dr. Umesh Negapurkar |
Approved |
| Sheth V.S. Hospital Ethics Committee, Ahmedabad, Dr. Hitendra Gandhi |
Submittted/Under Review |
| Spandana Ethics Committee, Bangalore, Dr. Mahesh Gowda |
Submittted/Under Review |
| The ethics committee, Chennai, Dr. R. Sathianathan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Major Depressive Disorder , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Duloxetine, 60 mg Q Day |
Capsule, oral, once daily for 8 weeks |
| Comparator Agent |
Placebo |
Tablet,oral, twice daily for 8 weeks |
| Intervention |
TC-5214, 1mg BID |
Tablet, oral, twice daily for 8 weeks
|
| Intervention |
TC-5214, 4mg BID |
Tablet, oral, twice daily for 8 weeks |
|
|
Inclusion Criteria
|
| 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.
Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
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 significant history of risk of suicide or homicide.
Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
Pregnancy or lactation.
|
|
|
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 |
| Changes in clinician rated symptoms as assessed by Clinical Global Impression-Improvement (CGI-I) |
Range of weeks 8 (baseline) to 16. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in clinician rated symptoms as assessed by MADRS |
Range of weeks 8 (baseline) to 16 |
| Changes in patient-reported outcomes as assessed by Sheehan Disability Scale (SDS) |
Range of weeks 8 (baseline) to 16. |
| Adverse Events (AEs)(any incidence) and Serious Adverse Events (SAEs), will be assessed as a measure of safety and tolerability. |
Range of weeks 8 (baseline) to 16. |
| Change in physical exam results, vital signs, lab tests (incl. ECG (electrocardiogram) will be assessed. |
Range of weeks 1-18 |
| Changes in clinician rated symptoms as assessed by Hamilton Rating Scale for Depression (HAMD). |
Range of weeks 8 (baseline) to 16 |
| Changes in clinician rated symptoms as assessed by Clinical Global Impression-Severity (CGI-S) |
Range of weeks 8 (baseline) to 16. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1152"
Sample Size from India="64"
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 2 |
|
Date of First Enrollment (India)
|
01/10/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/02/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
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 assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants. |