Neurobiological Effects of Light on MDD

NCT02940769 | Terminated

• 1 other identifier: PRITZ1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression; insomnia; light; cortisol; melatonin

Outcome Measures

Primary Outcomes (1)

• salivary cortisol levels

  Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)

Secondary Outcomes (1)

• salivary melatonin levels

  Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)

Study Arms (2)

light glasses

EXPERIMENTAL

Study subjects will wear light glasses

Device: light glasses

sham glasses (placebo)

SHAM COMPARATOR

Study subjects will wear sham glasses

Device: sham glasses (placebo)

Interventions

light glasses DEVICE

light glasses

light glasses

sham glasses (placebo) DEVICE

sham light glasses

sham glasses (placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Able to provide informed consent before beginning any study-specific procedures
• Not meet a current or lifetime DSM-IV Axis I disorder
• \) 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:

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Juan F. Lopez, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Emeritus

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 21, 2016
• Study Start: September 4, 2014
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)