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NCT04235686 · ClinicalTrials.gov registry record · Phase 2
8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT04235686: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT04235686 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04235686, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS\® as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS \® for this indication.
Primary Outcome
Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) between Baseline and Week 8 visit 10
Interventions
- DRUG Placebo
- DRUG Mydayis Extended-Release Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2020-07-17 |
| Est. Completion | 2025-07-25 |
| Phase | Phase 2 |
What the finished NCT04235686 record still lists
NCT04235686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04235686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04235686 about?
NCT04235686 is a clinical study titled "8 Week Multi-site Study of MYDAYIS® for Bipolar Depression". This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS\® as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS \® for this indication.
What is the current status of trial NCT04235686?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2020-07-17. Estimated completion is 2025-07-25.
What interventions are being tested in trial NCT04235686?
The interventions under investigation include: Placebo (DRUG), Mydayis Extended-Release Capsule (DRUG).
Who is sponsoring clinical trial NCT04235686?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04235686's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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