A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food

Summary

This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.

Timeline

Start

2008-04

Primary completion

2008-10

Completion

2008-12

Drugs

Indications