CTRI/2012/06/002750 [Registered on: 27/06/2012] Trial Registered Retrospectively
Last Modified On:
01/06/2012
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group 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 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
Secondary ID
Identifier
D4130C00002
Protocol Number
NCT01157078
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Jayanti Vasekar
Designation
Director
Affiliation
Quintiles Navigating the new health
Address
Quintiles Navigating the new health
301-A-1 Leela Business Park
MV Road
Andheri East
Mumbai
Mumbai MAHARASHTRA 400059 India
Phone
912020266087
Fax
912027032536
Email
jayanti.mathur@quintiles.com
Details of Contact Person Scientific Query
Name
Mr Gaurav Mathur
Designation
Associate Director
Affiliation
Quintiles Research (India) Pvt Ltd
Address
Quintiles Research (India) Pvt Ltd.
B-101-106, Shapath IV
Opp.Karnavati Club,
Sarkhej- Gandhinagar Road,
Ahmedabad, India
Ahmadabad GUJARAT 380051 India
Phone
917966303355
Fax
917966527272
Email
gaurav.mathur@quintiles.com
Details of Contact Person Public Query
Name
Suneela Thatte
Designation
Executive Director Clinical Operations
Affiliation
Quintiles Research (India) Pvt. Ltd.
Address
Quintiles Research (India) Pvt. Ltd.
301-A-1 Leela Business Park;
M.V.Road,
Andheri (E),
Mumbai, India
Mumbai MAHARASHTRA 400059 India
Phone
912266774242
Fax
912266774343
Email
Suneela.thatte@quintiles.com
Source of Monetary or Material Support
AstraZeneca AB
Primary Sponsor
Name
AstraZeneca AB
Address
S-151 85 Sodertalje, Sweden
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Quintiles Research India Pvt Ltd
2B Nitesh Broadway 9/3
MG Road
Bangalore 560001
Countries of Recruitment
Estonia Finland India Japan United States of America
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. 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.
4.Outpatient 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
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)
Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16)
Secondary Outcome
Outcome
TimePoints
Changes in clinician rated symptoms as assessed by Montgomery Asberg Depression Rating Scale (MADRS)
Range of weeks 8 (baseline) to 16
Target Sample Size
Total Sample Size="352" Sample Size from India="64" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Phase of Trial
Phase 2
Date of First Enrollment (India)
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
Years="1" Months="2" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Completed
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.