Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

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.

Conditions

• Bipolar Disorder
• Delayed Sleep-Wake Phase Disorder

Interventions

DRUG

Melatonin

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.

OTHER

Placebo

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.

BEHAVIORAL

Behavioral sleep intervention

An active intervention that is typically paired with melatonin to maximize treatment effects.

BEHAVIORAL

Behavioral 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.

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• Natrol

  collaborator UNKNOWN

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Leslie Swanson

  lead OTHER

Principal Investigators

• Leslie Swanson, PhD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-13

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations