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Study details
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Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Leslie Swanson
NCT IDNCT06226025ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

50

Study length

about 1.7 years

Ages

18–60

Locations

1 site in MI

About this study

This trial is testing whether a dietary supplement (low-dose melatonin) will help shift the brain clock earlier and improve mood and sleep in people with bipolar disorder. Participants will receive either melatonin plus a behavioral sleep intervention or a placebo plus a behavioral sleep placebo for 625 days.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Participate in Behavioral sleep control
  • 2.Participate in Behavioral sleep intervention
  • 3.Placebo
  • +1 more
PhasePhase 2
DrugMelatonin
Routeoral

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low12%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

melatonin (Hormone supplement; regulates sleep-wake cycle)

Drug routes

oral (Disintegrating Oral Tablet)

Endpoints

Secondary: Change in the Patient Health Questionnaire-9 (PHQ-9)

Body systems

Psychiatry / Mental Health