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1 Clinical Trial Details (PDF Generation Date :- Tue, 09 Apr :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/ [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 NCT 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 , INDIA Phone Fax Designation Affiliation veeresh.swamy@quintiles.com Details Contact Person (Scientific Query) Dr Shoibal Mukherjee VP Medical Phone Fax Designation Affiliation Quintiles Research () Pvt Ltd 8th Floor DLF Square, Jacaranda Marg, M Block, DLF Phase II Gurgaon Haryana Kurukshetra HARYANA 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 Mumbai MAHARASHTRA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > AstraZeneca AB S 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 Sodertalje, Sweden Pharmaceutical industry-global NIL of Site Site Phone/Fax/ opp. Sat. laurn hotel, Ashram road - Ahmadabad Ahmadabad GUJARAT Anjappa Jagadish Abhaya Hospital Psychiatry department,. 17, Dr. M. H. Marigowda Road, Wilson Garden, , Karnataka, Sanjay Phadke Venu Gopal Jhanwar Deenanath Mangeshkar Hospital & Research centre Deva Institute of Health care & Research Pvt. Ltd Erandawane, Pune , Maharashtra, Pune MAHARASHTRA Deva Institute of Health care & Research Pvt. Ltd, B - 27/70 mn, durgakund, Varanasi, UP Varanasi UTTAR PRADESH Dr Hitendra Gandhi Dr. Hitendra Gandhi Room. 14, Arogya Bhuvan, opp. Psychiatry ward, Sheth V.S. Hospital, Ellisbridge, Ahmedabad Ahmadabad mahesh_mitr@yahoo.c o.in a_jagadish@yahoo.co m sanjay_phadke@hotma il.com vgjhanwar@devainstitut e.com hitengandhi@yahoo.co. in page 2 / 6

3 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, Department of Psychiatry, Government drnnraju@yahoo.com Hospital For Mental Care, chainna waltair, Visakhapatnam East Kameng ARUNACHAL PRADESH Ward 120, Dept of Psychiatry, Madras Medical College and Government General Hospital, Chennai , Tamil Nadu, Chennai TAMIL NADU Mahendru Psychiatric Centre, 117/40, Sarvodaya Nagar, Kanpur Kanpur Nagar UTTAR PRADESH Near Jyoti Circle, Balmatta, Mangalore , Karnataka, Neuropsychiatry clinic, A-500,Govind Marg, Malviya Nagar, Jaipur,Rajasthan , Jaipur RAJASTHAN B -6, Hanuman Nagar, Sirsi Road, Jaipur Jaipur RAJASTHAN 549/46, 6th Main, 4th Block, Rajajinagar, , Karnataka, Sujatha Birla Hospital & opp. BYTCO college, Medical research centre Nashik road, Nashik, Nashik MAHARASHTRA sathianathen6@yahoo. com rkmahendru@indiatime s.com ravishthunga@yahoo.c om dr.tambianil@yahoo.co. in drrakeshyadav@hotmai l.com maheshrgowda@yahoo.com umeshanjali@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Abhaya Ethics Date Specified page 3 / 6

4 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

5 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 Year(s) 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

6 Powered by TCPDF ( 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/ /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