292
Participants
Start Date
October 31, 2006
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2013
Amitriptyline
25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.
Escitalopram
10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
Placebo
Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.
Mayo Clinic Jacksonville, Jacksonville
Mayo Clinic, Rochester
Northwestern University Chicago, Chicago
Saint Louis University School of Medicine, St Louis
Baylor College of Medicine, Houston
Mayo Clinic, Scottsdale
Dartmouth-Hitchcock Medical Center, Lebanon
McMaster University Centre, Hamilton
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Mayo Clinic
OTHER