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Trial · NCT06226025

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

NCT06226025, Phase 2, Recruiting, Leslie Swanson

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder. Trials, record NCT06226025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06226025

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
NCT number
NCT06226025
Status
Recruiting
Phases
Phase 2
Enrollment
50 participants, estimated
Lead sponsor
Leslie Swanson
Conditions
Bipolar Disorder, Delayed Sleep-Wake Phase Disorder
Interventions
Melatonin, Placebo, Behavioral sleep intervention, Behavioral sleep control
First posted
2024-01-26
Last updated
2026-05-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in time of Dim Light Melatonin Onset (DLMO) baseline (pre-treatment) to 4 weeks (post-treatment)4 weeks (after treatment period)
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.
SecondaryChange in the Patient Health Questionnaire-9 (PHQ-9)Baseline, 4 weeks (after treatment period)
The PHQ-9 is a 9-item self-report scale to screen for symptoms of depression. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R21MH132901Correcting Circadian Rhythms in Bipolar Disorder: Uncovering MechanismsSWANSON, LESLIE M; SPERRY, SARAH HAVENSUNIVERSITY OF MICHIGAN AT ANN ARBORNATIONAL INSTITUTE OF MENTAL HEALTH2024 to 2025

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06226025

GET https://conductscience.org/api/trials/v1/NCT06226025/registered