Neurobiological Effects of Light on MDD
Status: | Suspended |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/6/2019 |
Start Date: | September 4, 2014 |
End Date: | October 2022 |
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.
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
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
Inclusion Criteria:
1. Able to provide informed consent before beginning any study-specific procedures
2. Male and female patients at least 18-60 years of age
3. Women with reproductive potential must have a negative pregnancy test;
4. Meets DSM-IV criteria for Major Depressive disorder
5. Hamilton Depression Rating Scale total score of 15 or greater
6. Negative Drug screen for drugs of abuse
7. 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.
8. If currently on SSRI, subjects must have been on them for 6-8 weeks.
9. PSQI of >5 and without sleep difficulties unrelated to the depression
Exclusion criteria:
MDD subjects will be excluded if:
1. Subjects with a comorbid current primary Axis I disorder of OCD, Eating disorder or
any non-anxiety related Axis 1 diagnosis.
2. Subjects who meet DSM-IV criteria for substance dependence confirmed by the SCID, for
any substance except nicotine, within 3 months of screening.
3. Subjects who meet DSM-IV criteria for substance abuse within 3 months of screening.
4. Subjects with positive urine toxicology screen for illicit substances of abuse (aside
from cannabis, if patient not abusing and agrees to stop use).
5. 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.
6. Female subjects who are pregnant or who are breastfeeding or planning to become
pregnant during the study.
7. Subjects who, in investigator's opinion, would be non-compliant with the study
procedures
8. Subjects with current psychotic symptoms (delusions or hallucinations).
9. Existing sleep problems unrelated to the depression
10. Potential study subjects who are actively suicidal
Healthy Volunteers must fulfill all of the following inclusion criteria:
1. Able to provide informed consent before beginning any study-specific procedures
2. 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:
1. A current or lifetime DSM-IV Axis I disorder.
2. A positive urine toxicology screen for illicit substances of abuse (aside from
cannabis, if not abusing and agrees to stop use).
3. 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.
4. Females who are pregnant, breastfeeding or planning to become pregnant during the
study.
5. People who, in investigator's opinion, would be non-compliant with the study
procedures.
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Juan F Lopez, MD
Phone: 734-936-4820
University of Michigan The University of Michigan was founded in 1817 as one of the...
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