Neurobiological Effects of Light on MDD

NCT ID: NCT02940769

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-04
• Study Completion Date: 2017-02-14

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

Conditions

Major Depressive Disorder

Keywords

depression; insomnia; light; cortisol; melatonin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

light glasses

Study subjects will wear light glasses

Group Type: EXPERIMENTAL

light glasses

Intervention Type: DEVICE

light glasses

sham glasses (placebo)

Study subjects will wear sham glasses

Group Type: SHAM_COMPARATOR

sham glasses (placebo)

Intervention Type: DEVICE

sham light glasses

Interventions

light glasses

light glasses

Intervention Type: DEVICE

sham glasses (placebo)

sham light glasses

Intervention Type: DEVICE

Eligibility Criteria

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

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Juan Francisco Lopez

Associate Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan F. Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

PRITZ1

Identifier Type: -

Identifier Source: org_study_id