Health Trials

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 groups

Locations

1
University of Michigan48109, Ann ArborMichigan, United States

Sponsors 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