Clinical Trial Details (PDF Generation Date :- Tue, 09 Apr 2019 14:50:06 GMT) CTRI Number Last Modified On 11/04/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/10/002065 [Registered on: 14/10/2011] - Trial Registered Retrospectively Interventional Drug Randomized, Parallel Group, Multiple Arm Trial A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder. 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 Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) D4131C00001 NCT01288079 Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator KS Veeresh BPharm Associate Clinical Team Lead Quintiles Research () Private Limited 4th Floor, Nitesh Time Square 8, M. G. Road 560001, INDIA 560001 Phone 918066552069 Fax 918095502193 Email Designation Affiliation veeresh.swamy@quintiles.com Details Contact Person (Scientific Query) Dr Shoibal Mukherjee VP Medical Phone 911246755861 Fax 911246755959 Email Designation Affiliation Quintiles Research () Pvt Ltd 8th Floor DLF Square, Jacaranda Marg, M Block, DLF Phase II Gurgaon Haryana-122002 Kurukshetra HARYANA 122002 shoibal.mukherjee@quintiles.com Details Contact Person (Public Query) Suneela Thatte Executive Director Clinical Operations Quintiles Research () Pvt. Ltd. 301-A-1 Leela Business Park; M.V.Road, Andheri (E), Mumbai-400059 Mumbai MAHARASHTRA page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study 400059 Phone 912266774242 Fax 912266774343 Email Suneela.thatte@quintiles.com > AstraZeneca AB S-151 85 Sodertalje, Sweden Type of Sponsor NIL List of Countries Estonia Finland Japan United States of America of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details AstraZeneca AB Mahesh Chudgar Mental Illness Treatment Rehabilitation Foundation (MITR) S-151 85 Sodertalje, Sweden Pharmaceutical industry-global NIL of Site Site Phone/Fax/Email opp. Sat. laurn hotel, Ashram road - Ahmadabad 380013 Ahmadabad GUJARAT Anjappa Jagadish Abhaya Hospital Psychiatry department,. 17, Dr. M. H. Marigowda Road, Wilson Garden, - 560027, Karnataka, Sanjay Phadke Venu Gopal Jhanwar Deenanath Mangeshkar Hospital & Research centre Deva Institute of Health care & Research Pvt. Ltd Erandawane, Pune - 411 004, Maharashtra, Pune MAHARASHTRA Deva Institute of Health care & Research Pvt. Ltd, B - 27/70 mn, durgakund, Varanasi, UP - 221005 Varanasi UTTAR PRADESH Dr Hitendra Gandhi Dr. Hitendra Gandhi Room. 14, Arogya Bhuvan, opp. Psychiatry ward, Sheth V.S. Hospital, Ellisbridge, Ahmedabad - 380006 Ahmadabad 9825412109 mahesh_mitr@yahoo.c o.in 9844059066 a_jagadish@yahoo.co m 9823262786 sanjay_phadke@hotma il.com 9936611111 vgjhanwar@devainstitut e.com 9825066769 hitengandhi@yahoo.co. in page 2 / 6
Details of Ethics Committee Nadukuru oka Raju R Sathianadhan RK Mahendru Ravish Tunga Dr Anil Tambi Rakesh Yadav Mahesh Gowda Umesh Nagapurkar Government Hospital For Mental Care Madras Medical College and Government General Hospital Mahendru Psychiatric Centre Manaswini, Thunga Institute of Psychiatry and Counselling Mental Health care & Research R. K. Memorial Mental Health and deaddiction Hospital Spandana Nursing Home GUJARAT Dr. N N Raju, 9849111505 Department of Psychiatry, Government drnnraju@yahoo.com Hospital For Mental Care, chainna waltair, Visakhapatnam - 5300017 East Kameng ARUNACHAL PRADESH Ward 120, Dept of Psychiatry, Madras Medical College and Government General Hospital, Chennai - 6000003, Tamil Nadu, Chennai TAMIL NADU Mahendru Psychiatric Centre, 117/40, Sarvodaya Nagar, Kanpur-208 005 Kanpur Nagar UTTAR PRADESH Near Jyoti Circle, Balmatta, Mangalore - 575 001, Karnataka, Neuropsychiatry clinic, A-500,Govind Marg, Malviya Nagar, Jaipur,Rajasthan - 302017, Jaipur RAJASTHAN B -6, Hanuman Nagar, Sirsi Road, Jaipur - 302021 Jaipur RAJASTHAN 549/46, 6th Main, 4th Block, Rajajinagar, 560 010, Karnataka, Sujatha Birla Hospital & opp. BYTCO college, Medical research centre Nashik road, Nashik, 422101. Nashik MAHARASHTRA 9841019910 sathianathen6@yahoo. com 9336124372 rkmahendru@indiatime s.com 9845263090 ravishthunga@yahoo.c om 9828899902 dr.tambianil@yahoo.co. in 9829066418 drrakeshyadav@hotmai l.com 9845134915 maheshrgowda@yahoo.com 9823146088 umeshanjali@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Abhaya Ethics Date Specified page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Committee,, Dr. Anjappa Jagdish DMHC Ethics Committee, Varanasi, Dr. Venu Gopal Jhanwar Ethics Committee Memorial Mental Health and deaddiction Hospital, Jaipur, Dr. Rakesh Yadav Indepent Ethics Committee, Jaipur, Dr. Anil Tambi Institional Ethics Committee, Pune, Dr. Sanjay Phadke Institutional ethics committee, Vishakhapatnam, Dr. Nadukuru oka Raju Kanpur Medical ethics committee, Kanpur, Dr. R.K. Mahendru Malikatta Independent Ethical committee, Mangalore, Dr. Ravish Tunga-Manaswini Mitra foundation Ethics Committee, Ahmedabad, Dr. Mahesh Chudgar rth Maharastra Ethics Committee, Nashik, Dr. Umesh Negapurkar Sheth V.S. Hospital Ethics Committee, Ahmedabad, Dr. Hitendra Gandhi Spandana Ethics Committee,, Dr. Mahesh Gowda The ethics committee, Chennai, Dr. R. Sathianathan Status Approved 18/04/2011 Date Specified Approved 23/03/2011 Yes Date Specified Date Specified Approved 25/04/2011 Approved 26/03/2011 Yes Approved 15/04/2011 Approved 06/07/2011 Yes Date Specified Date Specified Approved 21/04/2011 Date Approved/Obtained 21/06/2011 Health Type Patients Condition Major Depressive Disorder Type Details Intervention TC-5214, 1mg BID Tablet, oral, twice daily for 8 Comparator Agent Duloxetine, 60 mg Q Day Capsule, oral, once daily for 8 page 4 / 6
Inclusion Criteria Comparator Agent Placebo Tablet,oral, twice daily for 8 Intervention TC-5214, 4mg BID Tablet, oral, twice daily for 8 Age From Age To Gender Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 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. Exclusion Criteria Details Exclusion Criteria 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 Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints assessed by Clinical Global Impression-Improvement (CGI-I) Range of 8 (baseline) to 16. Secondary Outcome Outcome Timepoints assessed by MADRS Changes in patient-reported outcomes as assessed by Sheehan Disability Scale (SDS) Range of 8 (baseline) to 16 Range of 8 (baseline) to 16. Adverse Events (AEs)(any incidence) and Range of 8 (baseline) to 16. Serious Adverse Events (SAEs), will be assessed as a measure of safety and tolerability. Change in physical exam results, vital signs, lab tests (incl. ECG (electrocardiogram) will be assessed. assessed by Hamilton Rating Scale for Range of 1-18 Range of 8 (baseline) to 16 page 5 / 6
Powered by TCPDF (www.tcpdf.org) Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Depression (HAMD). assessed by Clinical Global Impression-Severity (CGI-S) Total Sample Size=1152 Sample Size from =64 01/10/2011 04/02/2011 Years=1 Months=2 Days=0 Other (Terminated) Other (Terminated) Range of 8 (baseline) to 16. 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. page 6 / 6