TC-5214 as add-on the Treatment of Major Depressive Disorder
A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 in the Treatment of MDD With Subjects Who Are Partial Responders or Non-Responders to Citalopram Therapy
1 other identifier
interventional
574
2 countries
27
Brief Summary
This is a multi-center, double blind, randomized, placebo-controlled, parallel group, flexible dose titration study conducted in centers in the USA and India. Following a washout period, subject will be treated with citalopram 20 mg once daily for 4 weeks, then with 40 mg once daily for 4 weeks. Subjects who tolerate 40 mg citalopram, but whose MADRS score is \< 50% from baseline, but no lower than 17, will be considered partial or non-responders and will be randomized to receive either placebo or TC-5214 as add-on therapy. TC-5214 or placebo will be started at 2 mg daily (BID dosing), and be titrated based on tolerability and therapeutic response up to 8 mg daily. Approximately 560 subjects will enter the Open Label Phase and approximately 220 will enter the double blind phase of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Jun 2008
Shorter than P25 for phase_2 major-depressive-disorder
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJune 21, 2013
June 1, 2013
11 months
June 4, 2008
June 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change between TC-5214 and placebo from DB baseline (Week 8) of the HAMD-17 score, at Week 16.
16 Weeks
Secondary Outcomes (1)
Number of Participants with Adverse Events
16 Weeks
Study Arms (2)
citalopram + TC-5214
ACTIVE COMPARATORcitalopram + placebo
PLACEBO COMPARATORInterventions
TC-5214 (as TC-5214-23) will be provided as white, opaque, hard-gelatin capsules in strengths of 1, 2, and 4 mg.
Placebo will be provided with exactly the same shape, size and appearance. Subjects will take 2, 4, or 8 mg of study drug (or matching placebo), divided BID.
Eligibility Criteria
You may qualify if:
- Diagnosis of major depressive disorder (MDD) according to DSM-IV and confirmed via MINI diagnostic scale
- No more than 1 prior antidepressant course of treatment before trial entry.
- Able to give written informed consent.
- MADRS score greater than 27.
- CGI-S score greater than or equal to 4.
- No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests at screening.
- Women of child bearing potential must: a) have a negative urine pregnancy test, b) not be nursing, and c) be willing to use acceptable methods of contraception throughout the study period.
You may not qualify if:
- Any co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bipolar disorder, schizophrenia, dementia, or PTSD
- Subjects with significant suicidal risk upon clinical assessment utilizing the M.I.N.I.
- History of alcohol or drug abuse over the last 6 months
- History of seizures or seizure disorders
- Any other severe progressive and uncontrolled medical condition
- For other controlled medical conditions, medication to be unchanged over the 2 months preceding screening, or else the subject will be excluded
- Subjects with Glaucoma, Kidney Disease or Heart Disease
- Known hypersensitivity to mecamylamine
- Other investigational drug in previous 30 days
- Screening QTcB or QTcF \> 450 msec
- Current or prior citalopram treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Targacept Inc.lead
Study Sites (27)
Aurora Clinical Trials
Miami, Florida, 33143, United States
Community Research
Cincinnati, Ohio, 45227, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Sravani Poly Clinic and Mental Health
Guntur, Andhra Pradesh, Guntur-522001, India
Asha Hospital
Hyderabaad, Andhra Pradesh, 500034, India
Brain Mind Behaviour Neuroscience Research Institute
Maharanipet, Andhra Pradesh, 530002, India
VIMHANS
Vijaywada, Andhra Pradesh, 520002, India
Government Hospital for Mental Care, Dept. of Psychiatry
Visakhapatnam, Andhra Pradesh, 530017, India
SV Medical College
Tirupati, Chittoor District, Andhra Pradesh, 517507, India
AIIMS
New Dehli, Dehli, 110029, India
Sri Kishna Prasad Psychiatric Nursing Home
Ahmedabad, Gujarat, 380006, India
Victoria Hospital, Dept. of Psychiatry
Bangalore, Karnataka, 560002, India
St. John's Hospital
Bangalore, Karnataka, 560034, India
Adhit Kiran Neuro Psychiatric Centre
Mangalore, Karnataka, 572002, India
JSS Medical College Hospital, Dept. of Psychiatry
Mysore, Karnataka, 570004, India
Bhopal Memorial Hospital & Research Centre, Dept. of Psychiatry
Bhopal, Madhya Pradesh, 462038, India
Holy Family Hospital
Mumbai, Maharashtra, 400050, India
Deenanath Maneshkas Hospital
Pune, Maharashtra, 411 004, India
Sanjeevan Hospital
Pune, Maharashtra, 411004, India
Poona Hospital & Research Centre
Pune, Maharashtra, 411030, India
GB pant Hospital
Indraprastha, National Capital Territory of Delhi, 110002, India
Bhora Nuro Psychiatric Centre
New Delhi, National Capital Territory of Delhi, 110065, India
Gautam Hospital & Research Center
Jaipur, Rajasthan, 302006, India
Madras Medical College
Chennai, Tamil Nadu, 600003, India
M.S. Chellamuthu Trust & Research Foundation
Madurai, Tamil Nadu, 625 020, India
Mahendru Psychiatric Centre
Kanpur, Uttar Pradesh, 208005, India
C.S.M. Medical University, Department of Psychiatry
Lucknow, Uttar Pradesh, 226003, India
Related Publications (2)
Khan SA, Revicki DA, Hassan M, Locklear JC, Friedman LA, Mannix S, Tummala R, Dunbar GC, Eriksson H, Sheehan DV. Assessing the Reliability and Validity of the Sheehan Irritability Scale in Patients With Major Depressive Disorder. J Clin Psychiatry. 2016 Aug;77(8):1080-6. doi: 10.4088/JCP.14m09719.
PMID: 26579723DERIVEDXu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.
PMID: 24408516DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfredo N Rivera, MD
Community Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
June 1, 2008
Primary Completion
May 1, 2009
Study Completion
July 1, 2009
Last Updated
June 21, 2013
Record last verified: 2013-06