Neurobiological Effects of Light on MDD
Primary Purpose
Major Depressive Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
light glasses
sham glasses (placebo)
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Disorder focused on measuring depression, insomnia, light, cortisol, melatonin
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent before beginning any study-specific procedures
- Male and female patients at least 18-60 years of age
- Women with reproductive potential must have a negative pregnancy test;
- Meets DSM-IV criteria for Major Depressive disorder
- Hamilton Depression Rating Scale total score of 15 or greater
- Negative Drug screen for drugs of abuse
- No sleep altering medications, including herbal preparations. If subjects previously taking any of these medications, they need to be 1 week off of medications before starting the study.
- If currently on SSRI, subjects must have been on them for 6-8 weeks.
- PSQI of >5 and without sleep difficulties unrelated to the depression
Exclusion criteria:
MDD subjects will be excluded if:
- Subjects with a comorbid current primary Axis I disorder of OCD, Eating disorder or any non-anxiety related Axis 1 diagnosis.
- Subjects who meet DSM-IV criteria for substance dependence confirmed by the SCID, for any substance except nicotine, within 3 months of screening.
- Subjects who meet DSM-IV criteria for substance abuse within 3 months of screening.
- Subjects with positive urine toxicology screen for illicit substances of abuse (aside from cannabis, if patient not abusing and agrees to stop use).
- Subjects with a history of clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical findings that are unstable, or that in the opinion of the investigator, would confound biological assessments.
- Female subjects who are pregnant or who are breastfeeding or planning to become pregnant during the study.
- Subjects who, in investigator's opinion, would be non-compliant with the study procedures
- Subjects with current psychotic symptoms (delusions or hallucinations).
- Existing sleep problems unrelated to the depression
- Potential study subjects who are actively suicidal
Healthy Volunteers must fulfill all of the following inclusion criteria:
- Able to provide informed consent before beginning any study-specific procedures
- Not meet a current or lifetime DSM-IV Axis I disorder
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:
- A current or lifetime DSM-IV Axis I disorder.
- A positive urine toxicology screen for illicit substances of abuse (aside from cannabis, if not abusing and agrees to stop use).
- A history of clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical finding that is unstable or that, in the opinion of the investigator, would confound biological assessments.
- Females who are pregnant, breastfeeding or planning to become pregnant during the study.
- People who, in investigator's opinion, would be non-compliant with the study procedures.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
light glasses
sham glasses (placebo)
Arm Description
Study subjects will wear light glasses
Study subjects will wear sham glasses
Outcomes
Primary Outcome Measures
salivary cortisol levels
Secondary Outcome Measures
salivary melatonin levels
Full Information
NCT ID
NCT02940769
First Posted
September 22, 2015
Last Updated
December 20, 2022
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02940769
Brief Title
Neurobiological Effects of Light on MDD
Official Title
Neurobiological Effects of Light on MDD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding no longer available
Study Start Date
September 4, 2014 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
February 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, insomnia, light, cortisol, melatonin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
light glasses
Arm Type
Experimental
Arm Description
Study subjects will wear light glasses
Arm Title
sham glasses (placebo)
Arm Type
Sham Comparator
Arm Description
Study subjects will wear sham glasses
Intervention Type
Device
Intervention Name(s)
light glasses
Intervention Description
light glasses
Intervention Type
Device
Intervention Name(s)
sham glasses (placebo)
Intervention Description
sham light glasses
Primary Outcome Measure Information:
Title
salivary cortisol levels
Time Frame
Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)
Secondary Outcome Measure Information:
Title
salivary melatonin levels
Time Frame
Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent before beginning any study-specific procedures
Male and female patients at least 18-60 years of age
Women with reproductive potential must have a negative pregnancy test;
Meets DSM-IV criteria for Major Depressive disorder
Hamilton Depression Rating Scale total score of 15 or greater
Negative Drug screen for drugs of abuse
No sleep altering medications, including herbal preparations. If subjects previously taking any of these medications, they need to be 1 week off of medications before starting the study.
If currently on SSRI, subjects must have been on them for 6-8 weeks.
PSQI of >5 and without sleep difficulties unrelated to the depression
Exclusion criteria:
MDD subjects will be excluded if:
Subjects with a comorbid current primary Axis I disorder of OCD, Eating disorder or any non-anxiety related Axis 1 diagnosis.
Subjects who meet DSM-IV criteria for substance dependence confirmed by the SCID, for any substance except nicotine, within 3 months of screening.
Subjects who meet DSM-IV criteria for substance abuse within 3 months of screening.
Subjects with positive urine toxicology screen for illicit substances of abuse (aside from cannabis, if patient not abusing and agrees to stop use).
Subjects with a history of clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical findings that are unstable, or that in the opinion of the investigator, would confound biological assessments.
Female subjects who are pregnant or who are breastfeeding or planning to become pregnant during the study.
Subjects who, in investigator's opinion, would be non-compliant with the study procedures
Subjects with current psychotic symptoms (delusions or hallucinations).
Existing sleep problems unrelated to the depression
Potential study subjects who are actively suicidal
Healthy Volunteers must fulfill all of the following inclusion criteria:
Able to provide informed consent before beginning any study-specific procedures
Not meet a current or lifetime DSM-IV Axis I disorder
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:
A current or lifetime DSM-IV Axis I disorder.
A positive urine toxicology screen for illicit substances of abuse (aside from cannabis, if not abusing and agrees to stop use).
A history of clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical finding that is unstable or that, in the opinion of the investigator, would confound biological assessments.
Females who are pregnant, breastfeeding or planning to become pregnant during the study.
People who, in investigator's opinion, would be non-compliant with the study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F. Lopez, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Neurobiological Effects of Light on MDD
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