Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT02940769
Status:
TERMINATED
Last Update Posted:
2022-12-22
First Post:
2015-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurobiological Effects of Light on MDD
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Neurobiological Effects of Light on MDD
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding no longer available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: