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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Depression
• Intervention / Treatment: Drug: Placebo; Drug: Mydayis Extended-Release Capsule

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Cindy Stoppel; Phone Number: 507-284-5914; Email: stoppel.cynthia@mayo.edu
      • Principal Investigator: Mark A Frye, MD
      • Contact: Monica Walton; Phone Number: 507-422-0689; Email: Walton.Monica@mayo.edu
  • Ohio
    • Mason, Ohio, United States, 45040
      • Not yet recruiting
      • Lindner Center of Hope
      • Contact: Brian Martens, LSW, MS; Phone Number: 513-536-0720; Email: brian.martens@lindnercenter.org
      • Principal Investigator: Susan L McElroy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Male or female between 18 and 55 years of age
2. Bipolar I or II disorder as confirmed by structured diagnostic interview by Axis I of the SCID by DSM-IV-TR.
3. 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.
4. 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.
5. Patients with a comorbid attention deficit disorder and binge eating disorder will be included.
6. Patients will be allowed to continue with their behavioral treatments (ie. CBT) targeted at their primary diagnosis.

Exclusion Criteria

1. Ability to provide informed consent and understand fully English and score ≥ 90% on comprehension test questionnaire that reviews study goals.

2. Clinically significant signs of suicidality from any of the following assessments:

   1. Response ≥ 4 on MADRS question # 10
   2. Response ≥2 on QIDS-C or QIDS-SR question # 12
   3. 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)
   4. Suicide attempt within the past year, as defined by the Columbia-Suicide Severity Scale
3. Known lifetime history of DSM-IV-TR diagnosis of cocaine or methamphetamine abuse or dependence. Nicotine dependence will be an exception.
4. Positive toxicology screen for drugs of abuse (ie. cocaine, methamphetamine, cannabis, opiates)
5. Known history of prescription abuse of stimulants.
6. Lifetime history of stimulant-induced mania
7. Active abuse or dependence of alcohol, opiates or cannabis that is either current or less than 3 months full remission.
8. Baseline Young Mania Rating Scale (YMRS) score ≥ 8
9. Patients with active psychosis identified by SCID or a diagnosis of schizophrenia, schizoaffective disorder, delusional or schizophreniform disorder.
10. Known hypersensitivity, such as angioedema or anaphylaxis, to amphetamines or other ingredients of MYDAYIS.
11. Clinically unstable medical disease
12. Known history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke or other serious cardiovascular problems.
13. ECG with significant arrhythmias, conduction abnormalities, or voltage criteria met for left ventricular hypertrophy (unless cleared by cardiology consultation).
14. Uncontrolled hypertension (>160/100) or tachycardia (heart rate >110)
15. History of grand mal seizure; history of febrile seizure as infant permitted
16. Established vasculopathy or history of Raynaud's phenomena
17. Narrow angle glaucoma
18. Patients with end stage renal disease (ESRD).
19. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor.
20. Tourette's syndrome
21. 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)
22. Men who do not use adequate measures (male condoms).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: d-amphetamine / l-amphetamine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score	Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) between Baseline and Week 8 visit 10	Baseline to week 8 visit 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) score	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)	Baseline to Week 8 visit 10
Remission	Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score < 10) (Range 0-60)	Baseline to Week 8 visit 10
Change in General Anxiety Disorder 7-item scale score	Self-report anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7) (Range: 0-21)	Baseline to Week 8 visit 10
Response	Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60)	Baseline to Week 8 visit 10
Change in Clinical Global Impression for Bipolar Disorder (CGI-BP) score	Percentage of much or very much improved as measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP) (Range: 1-8)	Baseline to Week 8 visit 10
Change in Young Mania Rating Scale (YMRS) score	Reduction in sub-syndromal manic symptoms as measured by the Young Mania Rating Scale (YMRS) (Range: 0-56)	Baseline to Week 8 visit 10
Change in Epworth Sleepiness Scale (ESS) score	Self-report likelihood of falling asleep during normal daily situations as measured by the Epworth Sleepiness Scale (ESS) (Range: 0-24)	Baseline to Week 8 visit 10
Change in Fatigue Severity Scale (FSS) score	Self-report measure of fatigue as measured by the Fatigue Severity Scale (FSS) (Range: 0-63)	Baseline to Week 8 visit 10
Change in Binge Eating Scale (BES) score	Self-report binge eating behavior as measured by the Binge Eating Scale (BES) (Range: 0-48)	Baseline to Week 8 visit 10
Change in Morningness-Eveningness Questionnaire (MEQ) score	Self-Report measure on the Morningness-Eveningness Questionnaire (MEQ) (Range: 16-86)	Baseline to Week 8 visit 10
Change in Rapid Eating and Activity Assessment for Patients (REAP) score	Self-Report measure on Rapid Eating and Activity Assessment for Patients (REAP) (Range: 0-27)	Baseline to Week 8 visit 10
Change in Digit Symbol Substitution Test (DSST) score	Improvement in cognition as measured by the Digit Symbol Substitution Test (DSST) (Range: 0-100)	Baseline to Week 8 visit 10

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Lindner Center of HOPE
• Investigators: Principal Investigator: Mark A Frye, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Amphetamine; Dextroamphetamine
• Other Study ID Numbers: 19-001722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes