Clinical trial NCT01468038: A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
Official title: Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Disorder
Lead sponsor: Targeted Medical Pharma
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to fall asleep
timeFrame: 14 days
Secondary outcomes:
measure: Quality of Sleep
timeFrame: 14 days
measure: Morning grogginess
timeFrame: 14 days
measure: Feelings of depression
timeFrame: 14 days
measure: Feelings of anxiety
timeFrame: 14 days
measure: Improvement in parasympathetic activity
timeFrame: 14 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Targeted Medical Pharma
state: California
Study officials:
References: