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Bipolar DepressionPhase 2NCT04235686

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

A Phase 2 study testing Mydayis Extended-Release Capsule in people with Bipolar Depression, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Bipolar Depression
What is being tested?
Mydayis Extended-Release Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
2 sitesUnited States
Study dates
17 Jul 2020to 25 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
  • 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.
  • 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.
  • Patients with a comorbid attention deficit disorder and binge eating disorder will be included.
  • Patients will be allowed to continue with their behavioral treatments (ie. CBT) targeted at their primary diagnosis.

Who cannot join

  • Ability to provide informed consent and understand fully English and score ≥ 90% on comprehension test questionnaire that reviews study goals.
  • Clinically significant signs of suicidality from any of the following assessments:
  • Response ≥ 4 on MADRS question # 10
  • Response ≥2 on QIDS-C or QIDS-SR question # 12
  • 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)
  • 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.
  • Positive toxicology screen for drugs of abuse (ie. cocaine, methamphetamine, cannabis, opiates)
  • Known history of prescription abuse of stimulants.
  • Lifetime history of stimulant-induced mania
  • Active abuse or dependence of alcohol, opiates or cannabis that is either current or less than 3 months full remission.
  • Baseline Young Mania Rating Scale (YMRS) score ≥ 8
  • Patients with active psychosis identified by SCID or a diagnosis of schizophrenia, schizoaffective disorder, delusional or schizophreniform disorder.
  • Known hypersensitivity, such as angioedema or anaphylaxis, to amphetamines or other ingredients of MYDAYIS.
  • Clinically unstable medical disease
  • Known history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke or other serious cardiovascular problems.
  • ECG with significant arrhythmias, conduction abnormalities, or voltage criteria met for left ventricular hypertrophy (unless cleared by cardiology consultation).
  • Uncontrolled hypertension (>160/100) or tachycardia (heart rate >110)
  • History of grand mal seizure; history of febrile seizure as infant permitted
  • Established vasculopathy or history of Raynaud's phenomena
  • Narrow angle glaucoma
  • Patients with end stage renal disease (ESRD).
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor.
  • Tourette's syndrome
  • 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)
  • Men who do not use adequate measures (male condoms).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Lindner Center of Hope

    Mason, Ohio, 45040

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Being tested
Mydayis Extended-Release Capsule, Placebo
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mydayis Extended-Release CapsuleDrug

    Also called d-amphetamine / l-amphetamine

    Randomized, parallel - group, double-blind, placebo-controlled, flexible-dose adjunctive trial of MYDAYIS®

  • PlaceboDrug

    Matching placebo

Study groups in NCT04235686
Study groupRoleWhat they receive
Mydayis - ActiveActive comparatorMYDAYIS®, 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
Receives: Drug: Mydayis Extended-Release Capsule
PlaceboPlacebo comparatorMatching 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to week 8 visit 10

Secondary outcomes (12)

  1. 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)

    Measured: Baseline to Week 8 visit 10

  2. Remission

    Treatment remission (Montgomery-Asberg Depression Rating Scale (MADRS) score < 10) (Range 0-60)

    Measured: Baseline to Week 8 visit 10

  3. 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)

    Measured: Baseline to Week 8 visit 10

  4. Response

    Treatment response (50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60)

    Measured: Baseline to Week 8 visit 10

  5. 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)

    Measured: Baseline to Week 8 visit 10

  6. 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)

    Measured: Baseline to Week 8 visit 10

  7. 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)

    Measured: Baseline to Week 8 visit 10

  8. Change in Fatigue Severity Scale (FSS) score

    Self-report measure of fatigue as measured by the Fatigue Severity Scale (FSS) (Range: 0-63)

    Measured: Baseline to Week 8 visit 10

  9. Change in Binge Eating Scale (BES) score

    Self-report binge eating behavior as measured by the Binge Eating Scale (BES) (Range: 0-48)

    Measured: Baseline to Week 8 visit 10

  10. Change in Morningness-Eveningness Questionnaire (MEQ) score

    Self-Report measure on the Morningness-Eveningness Questionnaire (MEQ) (Range: 16-86)

    Measured: Baseline to Week 8 visit 10

  11. 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)

    Measured: Baseline to Week 8 visit 10

  12. Change in Digit Symbol Substitution Test (DSST) score

    Improvement in cognition as measured by the Digit Symbol Substitution Test (DSST) (Range: 0-100)

    Measured: Baseline to Week 8 visit 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start17 Jul 2020
  3. Primary completion25 Jul 2025
  4. Study completion25 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235686
Sponsor's protocol ID
19-001722
Status last verified
Aug 2025
First submitted
4 Dec 2019
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mydayis Extended-Release Capsule in people with Bipolar Depression, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score (time frame: Baseline to week 8 visit 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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