Trial | NCT01468038  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    trazodone ...

  • Study Participants

    111
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.
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 Started
Apr 30
2008
Primary Completion
Oct 31
2008
Study Completion
Dec 31
2008
Last Update
Nov 09
2011
Estimate

Drug Trazodone

active trazodone and sentra pm-like placebo

Other Sentra PM

Active Sentra PM and trazodone-like placebo

Drug Sentra PM and Trazodone (CoPack Kit Trazamine)

A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.

Drug Placebo trazodone and placebo Sentra PM

Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.

Active trazodone and placebo Active Comparator

trazodone 50mg with Sentra PM-like placebo

placebo and active Sentra PM Active Comparator

Trazodone-like placebo and Sentra PM

Sentra PM and trazodone Active Comparator

Active Sentra PM and active trazodone

placebo trazodone and placebo Sentra PM Placebo Comparator

trazadone-like placebo and Sentra PM-like placebo

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
No Results Posted