8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Mydayis - Active 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 |
Drug: Mydayis Extended-Release Capsule
Randomized, parallel - group, double-blind, placebo-controlled, flexible-dose adjunctive trial of MYDAYIS®
Other Names:
|
| Placebo Comparator: 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 |
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- Remission [Baseline to Week 8 visit 10]
Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score < 10) (Range 0-60)
- 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)
- Response [Baseline to Week 8 visit 10]
Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60)
- 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 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 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 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)
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria
-
Male or female between 18 and 55 years of age
-
Bipolar I or II disorder as confirmed by structured diagnostic interview by Axis I of the SCID by DSM-IV-TR.
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Currently experiencing a major depressive episode unresponsive to stable (i.e. at least 4 weeks) anti-manic mood stabilizers (lithium, valproate) and/or antipsychotic therapy, with or without concomitant antidepressant therapy.
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Symptom severity score ≥11 on the self-report version of the Quick Inventory for Depressive Symptomatology (QIDS-SR16) or score ≥11 on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) and ≥ 3 on the Clinical Global Impression for Bipolar Illness (CGI-BP) Depression Severity Scale.
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Patients with a comorbid attention deficit disorder and binge eating disorder will be included.
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Patients will be allowed to continue with their behavioral treatments (ie. CBT) targeted at their primary diagnosis.
Exclusion Criteria
-
Ability to provide informed consent and understand fully English and score ≥ 90% on comprehension test questionnaire that reviews study goals.
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Clinically significant signs of suicidality from any of the following assessments:
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Response ≥ 4 on MADRS question # 10
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Response ≥2 on QIDS-C or QIDS-SR question # 12
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Yes response on Columbia Suicide Severity Scale (CSSR) Question # 3 (ideation without plan or intent) ,Question #4 (ideation with intent, but no plan), or Question # 5 (ideation, intent, and plan)
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Suicide attempt within the past year, as defined by the Columbia-Suicide Severity Scale
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Known lifetime history of DSM-IV-TR diagnosis of cocaine or methamphetamine abuse or dependence. Nicotine dependence will be an exception.
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Positive toxicology screen for drugs of abuse (ie. cocaine, methamphetamine, cannabis, opiates)
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Known history of prescription abuse of stimulants.
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Lifetime history of stimulant-induced mania
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Active abuse or dependence of alcohol, opiates or cannabis that is either current or less than 3 months full remission.
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Baseline Young Mania Rating Scale (YMRS) score ≥ 8
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Patients with active psychosis identified by SCID or a diagnosis of schizophrenia, schizoaffective disorder, delusional or schizophreniform disorder.
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Known hypersensitivity, such as angioedema or anaphylaxis, to amphetamines or other ingredients of MYDAYIS.
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Clinically unstable medical disease
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Known history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke or other serious cardiovascular problems.
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ECG with significant arrhythmias, conduction abnormalities, or voltage criteria met for left ventricular hypertrophy (unless cleared by cardiology consultation).
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Uncontrolled hypertension (>160/100) or tachycardia (heart rate >110)
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History of grand mal seizure; history of febrile seizure as infant permitted
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Established vasculopathy or history of Raynaud's phenomena
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Narrow angle glaucoma
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Patients with end stage renal disease (ESRD).
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Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor.
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Tourette's syndrome
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Women who are pregnant, lactating or of child-bearing potential and not using at least one adequate contraceptive measure (i.e. hormonal contraception-birth control pills-, intrauterine devices (IUD), tubal ligation or condoms during sexual intercourse)
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Men who do not use adequate measures (male condoms).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
| 2 | Lindner Center of Hope | Mason | Ohio | United States | 45040 |
Sponsors and Collaborators
- Mayo Clinic
- Lindner Center of HOPE
Investigators
- Principal Investigator: Mark A Frye, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-001722