TC-5214 as add-on the Treatment of Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00692445|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Depression||Drug: TC-5214 + citalopram Drug: Placebo + citalopram||Phase 2|
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 reduced 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 (1mg BID dosing). After 2 weeks treatment, medication can be increased to 4 mg (2mg BID) or continued unchanged. Dose escalation will depend on good tolerability and inadequate therapeutic response. After a further 2 weeks, medication can be increased to 8 mg (4mg BID) if felt appropriate by the investigator. Again, dose escalation will depend on good tolerability and inadequate therapeutic response. At any time during the double blind phase of the study, placebo or TC-5214 can be reduced to the last previous dose level following the emergence of unacceptable adverse event(s).
If a subject is prematurely discontinued from the study between Week 8 and Week 16 for any reason, the investigator will make every effort to perform all evaluations as per protocol, assuming the subject had reached the end of the double blind Add:-on treatment phase. These evaluations are to be made as soon as possible but within 2 weeks of discontinuation.
For the subjects completing the double blind phase of the study, there will be a follow-up visit 2-3 weeks after the last dose of trial medication. At this follow-up, any signs or symptoms of relapse will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||574 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||July 2009|
|Active Comparator: citalopram + TC-5214||
Drug: TC-5214 + citalopram
TC-5214 (as TC-5214-23) will be provided as white, opaque, hard-gelatin capsules in strengths of 1, 2, and 4 mg.
Other Name: Mecamylamine
|Placebo Comparator: citalopram + placebo||
Drug: Placebo + citalopram
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.
- Mean change between TC-5214 and placebo from DB baseline (Week 8) of the HAMD-17 score, at Week 16. [ Time Frame: 16 Weeks ]
- Number of Participants with Adverse Events [ Time Frame: 16 Weeks ]Treatment emergent adverse events (TEAEs) will be tabulated and summarized by presenting the incidence (number of subjects) in each treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692445
|Principal Investigator:||Alfredo N Rivera, MD||Community Research|