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Light at Night Study (LAN)

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University of Michigan

Status

Terminated

Conditions

Bipolar Disorder
Light Sensitivity

Treatments

Other: Baseline light intensity, <1 lux
Other: Light intensity, ~30 lux

Study type

Interventional

Funder types

Other

Identifiers

NCT04251234
HUM00173528

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

  • Color blindness

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Healthy controls
Experimental group
Description:
* No co-morbid medical or psychiatry diagnoses * No family history of mental illness * No current medication use * Non-smoking
Treatment:
Other: Baseline light intensity, <1 lux
Other: Light intensity, ~30 lux
Bipolar I disorder
Experimental group
Description:
* 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
Treatment:
Other: Baseline light intensity, <1 lux
Other: Light intensity, ~30 lux

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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