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

Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder
• Intervention / Treatment: Drug: Trazodone; Other: Sentra PM; Drug: Sentra PM and Trazodone (CoPack Kit Trazamine); Drug: Placebo trazodone and placebo Sentra PM

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90077
      • Targeted Medical Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active trazodone and placebo; trazodone 50mg with Sentra PM-like placebo	Drug: Trazodone; active trazodone and sentra pm-like placebo
Active Comparator: placebo and active Sentra PM; Trazodone-like placebo and Sentra PM	Other: Sentra PM; Active Sentra PM and trazodone-like placebo
Active Comparator: Sentra PM and trazodone; Active Sentra PM and active trazodone	Drug: Sentra PM and Trazodone (CoPack Kit Trazamine); A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.
Placebo Comparator: placebo trazodone and placebo Sentra PM; trazadone-like placebo and Sentra PM-like placebo	Drug: Placebo trazodone and placebo Sentra PM; Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Targeted Medical Pharma

Publications and helpful links

Helpful Links

• Physician Therapeutics

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 5, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 8, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Antidepressive Agents, Second-Generation; Trazodone
• Other Study ID Numbers: SentraPM102