8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
- Conditions
- Bipolar Depression
- Interventions
- Drug: Placebo
- Registration Number
- NCT04235686
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo, Oral administration, dose regimen for Double blind phase and open label phase. 12.5 mg x 7 days. 25 mg x 7 days 37.5 mg x 14 days 50 mg daily x 28 days Mydayis - Active Mydayis Extended-Release Capsule MYDAYIS®, Oral administration, dose regimen for Double blind phase and open label phase. 12.5 mg x 7 days. 25 mg x 7 days 37.5 mg x 14 days 50 mg daily x 28 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Remission Baseline to Week 8 visit 10 Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score \< 10) (Range 0-60)
Change in Morningness-Eveningness Questionnaire (MEQ) score Baseline to Week 8 visit 10 Self-Report measure on the Morningness-Eveningness Questionnaire (MEQ) (Range: 16-86)
Change in Rapid Eating and Activity Assessment for Patients (REAP) score Baseline to Week 8 visit 10 Self-Report measure on Rapid Eating and Activity Assessment for Patients (REAP) (Range: 0-27)
Change in Digit Symbol Substitution Test (DSST) score Baseline to Week 8 visit 10 Improvement in cognition as measured by the Digit Symbol Substitution Test (DSST) (Range: 0-100)
Response Baseline to Week 8 visit 10 Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60)
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)
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)
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)
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)
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)
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)
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)
Trial Locations
- Locations (2)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Lindner Center of Hope
🇺🇸Mason, Ohio, United States