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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01468038
First received: November 5, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Sleep Disorder
Drug: Trazodone
Other: Sentra PM
Drug: Sentra PM and Trazodone (CoPack Kit Trazamine)
Drug: Placebo trazodone and placebo Sentra PM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders

Resource links provided by NLM:


Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • Time to fall asleep [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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:
  • Quality of Sleep [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Morning grogginess [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Feelings of depression [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Feelings of anxiety [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Improvement in parasympathetic activity [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Improved parasympathetic activity measured by 24 hour ECG holter moniter.


Enrollment: 111
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468038

Locations
United States, California
Targeted Medical Pharma
Los Angeles, California, United States, 90077
Sponsors and Collaborators
Targeted Medical Pharma
  More Information

Additional Information:
No publications provided

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01468038     History of Changes
Other Study ID Numbers: SentraPM102
Study First Received: November 5, 2011
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on July 29, 2014