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

Overview

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.

Full Title of Study: “An 8 Week Randomized Double Blind Placebo Controlled Multi-site Study Assessing Efficacy and Safety of MYDAYIS® (D-amphetamine / L-amphetamine) for Bipolar Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2022

Interventions

  • Drug: Mydayis Extended-Release Capsule
    • Randomized, parallel – group, double-blind, placebo-controlled, flexible-dose adjunctive trial of MYDAYIS®
  • Drug: Placebo
    • Matching placebo

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
    • Time Frame: 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 Measures

  • Change in Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) score
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Baseline to Week 8 visit 10
    • Improvement in cognition as measured by the Digit Symbol Substitution Test (DSST) (Range: 0-100)

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • Lindner Center of HOPE
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark Frye, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Mark A Frye, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.