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

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235686
• Other study ID #: 19-001722
• Status: Recruiting
• Phase: Phase 2
• Start date: July 17, 2020
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Lindner Center of Hope	Mason	Ohio
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Lindner Center of HOPE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Remission	Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score < 10) (Range 0-60)	Baseline to Week 8 visit 10
Secondary	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
Secondary	Response	Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60)	Baseline to Week 8 visit 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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