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The primary study objective is to observe/measure the circadian pattern of sleep, Cortisol and Melatonin in MDD subjects and Control subjects. We will also assess if controlled exposure to light in MDD subjects (post-partum females, non- post-partum females and males) will change these parameters using light glasses. In addition to the biological outcome measures (sleep, cortisol and melatonin) we will also monitor sleep and depressive symptoms in the research subjects for the duration of the protocol.
In this study we will collect baseline hormone data and clinical data along with assessing light exposure using a Daysimeter in MDD participants and control subjects. We will collect baseline Daysimeter data for 5 days and then collect cortisol and melatonin levels in both MDD subjects and Control Subjects. Control subjects will complete the study following the sample collection. MDD participants will then have a light intervention (sham or active).
Following the Daysimeter and hormone data collection, MDD subjects in each group will be randomly assigned into a non-treatment group or treatment group. While continuing to wear the Daysimeter, all MDD subjects will wear assigned glasses for 2 hours prior to bedtime. The subject will choose the bedtime hour and try and consistently wear the glasses at the same time throughout the study. Subjects will then wear the assigned glasses in the am upon waking for 1 hour. Following 7 days wearing the assigned glasses MDD subjects will repeat the sample collection for Cortisol and Melatonin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| light glasses | Experimental | Study subjects will wear light glasses |
|
| sham glasses (placebo) | Sham Comparator | Study subjects will wear sham glasses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| light glasses | Device | light glasses |
| |
| sham glasses (placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| salivary cortisol levels | Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13) |
| Measure | Description | Time Frame |
|---|---|---|
| salivary melatonin levels | Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13) |
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Inclusion Criteria:
Exclusion criteria:
MDD subjects will be excluded if:
Healthy Volunteers must fulfill all of the following inclusion criteria:
2) Male and female patients at least 18 years of age 3) Women with reproductive potential must have a negative pregnancy test; 4) Medication free, including herbal medications 5) Negative drug screen for drugs of abuse. 6) PSQI of < 5
Healthy volunteers will be excluded if:
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| Name | Affiliation | Role |
|---|---|---|
| Juan F. Lopez, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Device |
sham light glasses |
|
| D001519 |
| Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |