Trials / Completed
CompletedNCT04235686
8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
An 8 Week Randomized Double Blind Placebo Controlled Multi-site Study Assessing Efficacy and Safety of MYDAYIS® (D-amphetamine / L-amphetamine) for Bipolar Depression
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mydayis Extended-Release Capsule | Randomized, parallel - group, double-blind, placebo-controlled, flexible-dose adjunctive trial of MYDAYIS® |
| DRUG | Placebo | Matching placebo |
Timeline
- Start date
- 2020-07-17
- Primary completion
- 2025-07-25
- Completion
- 2025-07-25
- First posted
- 2020-01-22
- Last updated
- 2025-08-12
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04235686. Inclusion in this directory is not an endorsement.