Trial · NCT07472075
Melatonin Versus Placebo for Bipolar Disorder
NCT07472075, Phase 2, Recruiting, Lars Vedel Kessing
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin Versus Placebo for Bipolar Disorder. Trials, record NCT07472075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07472075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin Versus Placebo for Bipolar Disorder
- NCT number
- NCT07472075
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Lars Vedel Kessing
- Conditions
- Bipolar Affective Disorder
- Interventions
- Melatonin, Placebo
- First posted
- 2026-03-16
- Last updated
- 2026-05-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mood stabilization | 6 months | Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings. |
| Secondary | Sleep | 6 months | Change in sleep measured by change from baseline on the Pittsburgh Sleep Quality Index (min. value = 0; max. value = 21 with higher scores indicating poorer sleep quality) on 3 months visit and 6 months visit |
| Secondary | Depression | Changes between baseline, 3 months and 6 months | The clinical rating of depression is assessed using the Hamilton Rating Scale for Depression, 6 items (HAM-D6), (min. value=0; max. value = 22 with higher scores reflecting more severe depression ) |
| Other | Mania/hypomania | Changes between baseline, 3 months and 6 months | The clinical rating of (hypo)mania is assessed using the Young Mania Rating Scale (YMRS) (Min. value = 0; max. value = 60 with higher values reflecting more manic symptoms) \[Clinically rated observer-based difference in scores over the 6 months trial, measured at baseline, 3 months and 6 months\] |
| Other | Functioning | Changes between baseline, 3 months and 6 months | Functioning is assessed using the Functional Assessment Short Test (FAST) (Min. value = 0, max. value = 72 with higher values reflecting poorer function). |
| Other | Perceived stress | Changes between baseline, 3- and 6 months | Assessed using Cohen's Perceived Stress Scale (PSS), a 10-item questionnaire. (Min. value = 0; max. value = 40, with higher values reflecting increased stress level) |
| Other | Cognition | Changes between baseline and 6 months | Assessed using the self-administered questionnaire, Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) (Min. value = 0; max. value = 48, the higher the score, the higher the number of subjective complaints) |
| Other | Non-response to standard mood stabilizing treatment | 6 months | Non-response to standard mood stabilizing treatment, where standard treatment is defined as lithium or lamotrigine. If one of the following situations occurs after treatment allocation, the date is registrered as "non-response to treatment" defined as: 1. Add-on of a second mood stabilizer (lithium or lamotrigine) in addition to the initial mood stabilizer (lithium or lamotrigine) 2. Add-on of an antidepressant 3. Add-on of quetiapine \> 100 mg/day or another antipsychotic drug The patient will continue the trial follow-up in case of non-response |
| Other | Chronotype | 6 months | Assessed using the Morningness-Eveningness questionnaire (MEQ). (Min. value 16, max. value 86. A value of 41 or below indicate an "evening type". Value of 59 or above indicate a "morning type". Values between 42-58 indicate an "intermediate type") |
Source ClinicalTrials.gov
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.
Grants0
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.
None in this release.
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.
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/NCT07472075
GET https://conductscience.org/api/trials/v1/NCT07472075/registered