46
Participants
Start Date
November 30, 2010
Primary Completion Date
October 31, 2013
Study Completion Date
October 31, 2013
Milnacipran
Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
Placebo
Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
Collaborators (1)
Forest Laboratories
INDUSTRY
Dr. Norman Harden
OTHER