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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06226025
The ClinicalTrials.gov registry entry for NCT06226025 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (85% lower). The listed sponsor is Leslie Swanson, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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