TC-5214 as add-on the Treatment of Major Depressive Disorder
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
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.