Trial · NCT04235686
8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
NCT04235686, Phase 2, Completed, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 8 Week Multi-site Study of MYDAYIS® for Bipolar Depression. Trials, record NCT04235686. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04235686
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
- NCT number
- NCT04235686
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Bipolar Depression
- Interventions
- Mydayis Extended-Release Capsule, Placebo
- First posted
- 2020-01-22
- Last updated
- 2025-08-12
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) score | Baseline to week 8 visit 10 | Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) between Baseline and Week 8 visit 10 |
| Secondary | Change in Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) score | Baseline to Week 8 visit 10 | Reduction in Clinician and self-report symptoms of depression as measured by the Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) (Range: 0-27) |
| Secondary | Remission | Baseline to Week 8 visit 10 | Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score \< 10) (Range 0-60) |
| Secondary | Change in General Anxiety Disorder 7-item scale score | Baseline to Week 8 visit 10 | Self-report anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7) (Range: 0-21) |
| Secondary | Response | Baseline to Week 8 visit 10 | Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) |
| Secondary | Change in Clinical Global Impression for Bipolar Disorder (CGI-BP) score | Baseline to Week 8 visit 10 | Percentage of much or very much improved as measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) (Range: 1-8) |
| Secondary | Change in Young Mania Rating Scale (YMRS) score | Baseline to Week 8 visit 10 | Reduction in sub-syndromal manic symptoms as measured by the Young Mania Rating Scale (YMRS) (Range: 0-56) |
| Secondary | Change in Epworth Sleepiness Scale (ESS) score | Baseline to Week 8 visit 10 | Self-report likelihood of falling asleep during normal daily situations as measured by the Epworth Sleepiness Scale (ESS) (Range: 0-24) |
| Secondary | Change in Fatigue Severity Scale (FSS) score | Baseline to Week 8 visit 10 | Self-report measure of fatigue as measured by the Fatigue Severity Scale (FSS) (Range: 0-63) |
| Secondary | Change in Binge Eating Scale (BES) score | Baseline to Week 8 visit 10 | Self-report binge eating behavior as measured by the Binge Eating Scale (BES) (Range: 0-48) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
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/NCT04235686
GET https://conductscience.org/api/trials/v1/NCT04235686/registered