Bipolar DisorderLANNCT04251234
Light at Night Study
A study testing Light intensity, ~30 lux and Baseline light intensity, <1 lux in people with Bipolar Disorder and Light Sensitivity, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Light Sensitivity
- What is being tested?
- Light intensity, ~30 lux and Baseline light intensity, <1 lux
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 4 Aug 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-30 kg/m2
- Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary
- Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center
- Willing and able to maintain stable sleep schedule during study.
- Participants will be breathalyzed and undergo urine drugs screens at every lab visit
- Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs
Who cannot join
- Color blindness
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.
Read the detailed description
The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.
- Conditions
- Bipolar Disorder, Light Sensitivity
- Being tested
- Light intensity, ~30 lux, Baseline light intensity, <1 lux
- Keywords
- Circadian, Light Intensity
- Medical subject headings
- Bipolar Disorder, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light intensity, ~30 luxOther
~30 lux compared to very dim light baseline condition <1 lux
Baseline light intensity, <1 luxOther
Very dim light condition
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Experimental | * No co-morbid medical or psychiatry diagnoses
* No family history of mental illness
* No current medication use
* Non-smoking Receives: Other: Light intensity, ~30 lux; Other: Baseline light intensity, <1 lux |
| Bipolar I disorder | Experimental | * Clinical diagnosis of Bipolar I disorder
* Can be (not required, not exclusionary) taking lithium and/or sodium valproate and/or antidepressants
* Can be (not required, not exclusionary) light smokers Receives: Other: Light intensity, ~30 lux; Other: Baseline light intensity, <1 lux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin levels
Melatonin will be reported as an average percentage of suppression in the ~30 lux condition as compared to <1 lux
Measured: Up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 Oct 2020
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Why it stopped: COVID shutdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Burgess, University of Michigan
- Investigators
- Helen Burgess, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251234
- Sponsor's protocol ID
- HUM00173528
- Acronym
- LAN
- Status last verified
- Aug 2021
- First submitted
- 30 Jan 2020
- Last updated
- 12 Aug 2021
- Results posted
- 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light at Night Study
- ClinicalTrials.gov ID
- NCT04251234
- Acronym / sponsor ID
- LAN / HUM00173528
- Conditions
- Bipolar Disorder, Light Sensitivity
- Keywords
- Circadian, Light Intensity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID shutdown
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- 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 purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.
Detailed description
The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Experimental | Other: Light intensity, ~30 lux, Other: Baseline light intensity, <1 lux* No co-morbid medical or psychiatry diagnoses * No family history of mental illness * No current medication use * Non-smoking |
| Bipolar I disorder | Experimental | Other: Light intensity, ~30 lux, Other: Baseline light intensity, <1 lux* Clinical diagnosis of Bipolar I disorder * Can be (not required, not exclusionary) taking lithium and/or sodium valproate and/or antidepressants * Can be (not required, not exclusionary) light smokers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI 18-30 kg/m2
- Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary
- Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center
- Willing and able to maintain stable sleep schedule during study.
- Participants will be breathalyzed and undergo urine drugs screens at every lab visit
Key exclusion criteria (1 listed)
- Color blindness
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 intensity, ~30 lux~30 lux compared to very dim light baseline condition <1 lux | Other | Bipolar I disorder, Healthy controls |
| Baseline light intensity, <1 luxVery dim light condition | Other | Bipolar I disorder, Healthy controls |
Primary outcome
Melatonin levels
Time frame: Up to approximately 6 weeks
Melatonin will be reported as an average percentage of suppression in the ~30 lux condition as compared to <1 lux
Results and safety
The study was stopped early (reason given: COVID shutdown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Helen Burgess, PhD 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 intensity, ~30 lux and Baseline light intensity, <1 lux in people with Bipolar Disorder and Light Sensitivity, 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 6 inclusion and 1 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 12 Aug 2021. 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. 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: COVID shutdown). 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?
Melatonin levels (time frame: Up to approximately 6 weeks). 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 12 Aug 2021.