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

Phase 3

Completed

• Conditions: Sleep Disorder
• Interventions: Drug: Trazodone; Other: Sentra PM; Drug: Placebo trazodone and placebo Sentra PM; Drug: Sentra PM and Trazodone (CoPack Kit Trazamine)

• Registration Number: NCT01468038
• Lead Sponsor: Targeted Medical Pharma

Brief 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.

Detailed Description

Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Status Verified: 2011-11
• Study First Submitted: 2011-11-05
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active trazodone and placebo	Trazodone	trazodone 50mg with Sentra PM-like placebo
placebo and active Sentra PM	Sentra PM	Trazodone-like placebo and Sentra PM
placebo trazodone and placebo Sentra PM	Placebo trazodone and placebo Sentra PM	trazadone-like placebo and Sentra PM-like placebo
Sentra PM and trazodone	Sentra PM and Trazodone (CoPack Kit Trazamine)	Active Sentra PM and active trazodone

Primary Outcome Measures

Name	Time	Method
Time to fall asleep	14 days	Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen.

Secondary Outcome Measures

Name	Time	Method
Quality of Sleep	14 days
Morning grogginess	14 days
Feelings of depression	14 days
Feelings of anxiety	14 days
Improvement in parasympathetic activity	14 days	Improved parasympathetic activity measured by 24 hour ECG holter moniter.

Trial Locations

Locations (1)

Targeted Medical Pharma; 🇺🇸 Los Angeles, California, United States