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NCT06226025 · ClinicalTrials.gov registry record · Phase 2
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
A Phase 2 study of Bipolar Disorder and Delayed Sleep-Wake Phase Disorder, sponsored by Leslie Swanson.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06226025: Recruiting Phase 2 study of Bipolar Disorder and Delayed Sleep-Wake Phase Disorder, sponsored by Leslie Swanson.
NCT06226025 is a Phase 2 study of Bipolar Disorder and Delayed Sleep-Wake Phase Disorder that is actively recruiting participants, run by Leslie Swanson. The registered enrollment target is 50 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06226025, a Phase 2 study of Bipolar Disorder and Delayed Sleep-Wake Phase Disorder, is actively recruiting participants, sponsored by Leslie Swanson.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Melatonin
- BEHAVIORAL Behavioral sleep intervention
- BEHAVIORAL Behavioral sleep control
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What NCT06226025 shows while recruiting
NCT06226025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06226025 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06226025 about?
NCT06226025 is a clinical study titled "Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder". 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...
What is the current status of trial NCT06226025?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-08-13. Estimated completion is 2026-04.
What conditions does trial NCT06226025 study?
This clinical trial studies the following conditions: Bipolar Disorder, Delayed Sleep-Wake Phase Disorder.
What interventions are being tested in trial NCT06226025?
The interventions under investigation include: Placebo (OTHER), Melatonin (DRUG), Behavioral sleep intervention (BEHAVIORAL), Behavioral sleep control (BEHAVIORAL).
Who is sponsoring clinical trial NCT06226025?
This trial is sponsored by Leslie Swanson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06226025 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06226025's enrollment target sits among peer trials
50 108th of 162 higher than 50 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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