Light at Night Study

Not Applicable

Terminated

• Conditions: Bipolar Disorder; Light Sensitivity
• Interventions: Other: Light intensity, ~30 lux; Other: Baseline light intensity, <1 lux

• Registration Number: NCT04251234
• Lead Sponsor: University of Michigan

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2020-10-15
• Status Verified: 2021-08
• Primary Completion: 2021-08-04
• Study Completion: 2021-08-04
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• 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

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Exclusion Criteria

• Color blindness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Light intensity, ~30 lux	* No co-morbid medical or psychiatry diagnoses * No family history of mental illness * No current medication use * Non-smoking
Healthy controls	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	Light intensity, ~30 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
Bipolar I disorder	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

Primary Outcome Measures

Name	Time	Method
Melatonin levels	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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States