Major Depressive DisorderNCT02940769
Neurobiological Effects of Light on MDD
A study testing light glasses in people with Major Depressive Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- light glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2014to 14 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- light glasses, sham glasses (placebo)
- Keywords
- depression, insomnia, light, cortisol, melatonin
- Medical subject headings
- Depressive Disorder, Major, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light glassesDevice
light glasses
sham glasses (placebo)Device
sham light glasses
| Study group | Role | What they receive |
|---|---|---|
| light glasses | Experimental | Study subjects will wear light glasses Receives: Device: light glasses |
| sham glasses (placebo) | Sham comparator | Study subjects will wear sham glasses Receives: Device: sham glasses (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary cortisol levels
Measured: Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)
Secondary outcomes (1)
salivary melatonin levels
Measured: Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start4 Sep 2014
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
Why it stopped: Funding no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Francisco Lopez, University of Michigan
- Investigators
- Juan F. Lopez, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940769
- Sponsor's protocol ID
- PRITZ1
- Status last verified
- Dec 2022
- First submitted
- 22 Sep 2015
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Effects of Light on MDD
- ClinicalTrials.gov ID
- NCT02940769
- Acronym / sponsor ID
- PRITZ1
- Conditions
- Major Depressive Disorder
- Keywords
- depression, insomnia, light, cortisol, melatonin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding no longer available
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| light glasses | Experimental | Device: light glassesStudy subjects will wear light glasses |
| sham glasses (placebo) | Sham comparator | Device: sham glasses (placebo)Study subjects will wear sham glasses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| light glasseslight glasses | Device | light glasses |
| sham glasses (placebo)sham light glasses | Device | sham glasses (placebo) |
Primary outcome
salivary cortisol levels
Time frame: Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)
1 secondary outcome
salivary melatonin levels
Time frame: Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)
Results and safety
The study was stopped early (reason given: Funding no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F. Lopez, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light glasses in people with Major Depressive Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding no longer available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary cortisol levels (time frame: Change is being assessed over time following the intervention (day 5, day 6, day 12 & day 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.