Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Recruiting Phase 2 Interventional Study
Bipolar Disorder Delayed Sleep-Wake Phase Disorder
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Leslie Swanson · Other
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About This Trial
The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a beha…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Capable of giving informed consent * Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for bipolar disorder (BD) I or II * Evening chronotype per the Morningness-Eveningness Questionnaire (MEQ) defined by a score of \<42 * At least mild depressive s…
Contacts

Kelley DuBuc

734-764-2256

dubuck@umich.edu

CONTACT