Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLeslie Swanson
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 behavioral sleep placebo.
The hypotheses for this study include:
* Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment. * Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.
Eligibility criteria
Qualifiers
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 symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5
Disqualifiers
Insomnia per DSM-5
Sleep-disordered breathing per Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP-BANG)
Restless leg syndrome per sleep interview
Narcolepsy
Trial design
Treatments tested in this trial
- Melatonin
- Placebo
- Behavioral sleep intervention
- Behavioral sleep control
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Leslie Swanson
Lead sponsor
University of Michigan
Sponsor institution
University of Michigan
Collaborator
Natrol
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov