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8 Week Multi-site Study of MYDAYIS® for Bipolar Depression

NCT04235686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-08-12

No results posted yet for this 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.

Conditions

Interventions

DRUG

Mydayis Extended-Release Capsule

Randomized, parallel - group, double-blind, placebo-controlled, flexible-dose adjunctive trial of MYDAYIS®

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Lindner Center of HOPE

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Mark A Frye · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2025-07-25
Completion
2025-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235686 on ClinicalTrials.gov