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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone | Drug | active trazodone and sentra pm-like placebo |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Sleep | 14 days | |
| Morning grogginess | 14 days | |
| Feelings of depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Targeted Medical Pharma | Los Angeles | California | 90077 | United States |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| Sentra PM |
| Other |
Active Sentra PM and trazodone-like placebo |
|
| Sentra PM and Trazodone (CoPack Kit Trazamine) | Drug | A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone. |
|
| Placebo trazodone and placebo Sentra PM | Drug | Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit. |
|
| 14 days |
| Feelings of anxiety | 14 days |
| Improvement in parasympathetic activity | Improved parasympathetic activity measured by 24 hour ECG holter moniter. | 14 days |
| D001523 | Mental Disorders |
| D011725 |
| Pyridines |