Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 13, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Bipolar DisorderDelayed 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.

Trial Locations (1)

48109

RECRUITING

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

University of Michigan

OTHER

collaborator

Natrol

UNKNOWN

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Leslie Swanson

OTHER