Status:
COMPLETED
A Wearable Morning Light Treatment for Postpartum Depression
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Post Partum Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock...
Detailed Description
Please note this project added a sub-study (HUM00235787, IRB approved on 7/31/2024) to the main study. However, the sub-study only applies to some of the participants and there are only exploratory ou...
Eligibility Criteria
Inclusion
- less or equal (≤) to 26 weeks postpartum
- meet criteria for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V)
- not currently receiving treatment for depression (for example, prescription medications or psychotherapy).
Exclusion
- Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder if the onset is outside of the perinatal period, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID.
- current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy.
- retinal pathology or history of eye surgery
- current use of photosensitizing medications,
- current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers)
- medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures).
- nightshift work
- currently pregnant
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04845347
Start Date
June 23 2021
End Date
July 24 2025
Last Update
August 6 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109