Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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 intervention phase

• Female participants of childbearing potential (i.e., patients are not permanently sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or postmenopausal (12 months with no menses without an alternative medical cause) by report) must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Kelley DuBuc
dubuck@umich.edu
734-764-2256
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2026-04
Participants
Target number of participants: 50
Treatments
Experimental: Melatonin
Oral medication will be taken for 28 days on the afternoon or evening of the participants first intervention session and continue daily for the remainder of the treatment period.
Placebo_comparator: Placebo
Oral medication will be taken for 28 days on the afternoon or evening of the participants first intervention session and continue daily for the remainder of the treatment period.
Related Therapeutic Areas
Sponsors
Collaborators: Natrol, University of Michigan, National Institute of Mental Health (NIMH)
Leads: Leslie Swanson

This content was sourced from clinicaltrials.gov