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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targeted Medical Pharma
• Treatments: Trazodone

Criteria

Inclusion Criteria:

• Males and females over the age of 18 and below age 65.

• Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.

Exclusion Criteria:

• Subjects who have previously taken GABAdone, SentraPM or trazadone.

• Subjects who are currently taking tricyclic anti-depressants.

• Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.

• Pregnant or lactating females.

• Subjects with implanted pacemakers or other implanted electrical devices