Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Leslie Swanson
Summary
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
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
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 symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5 * Psychotropic medications at stable dose for past month * Able to download the MyDataHelps mobile application (app), and open app on participants' own phone * Willing to abstain from alcohol for the duration of the interventi…
Interventions
- DrugMelatonin
Participants randomized to this intervention will take 1 oral pill (0.5 milligrams (mg)) daily. They will attend 4 weekly behavioral sleep intervention sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.
- OtherPlacebo
Participants randomized to this intervention will take 1 oral placebo pill daily. They will attend 4 weekly behavioral sleep control sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.
- BehavioralBehavioral sleep intervention
An active intervention that is typically paired with melatonin to maximize treatment effects.
- BehavioralBehavioral sleep control
A behavioral placebo (which does not improve sleep in delayed sleep-wake phase disorder) to control for social/interpersonal effects of behavioral sleep intervention sessions.
Location
- University of MichiganAnn Arbor, Michigan