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

NCT04235686 | Completed Phase 2 FDA Drug

• 1 other identifier: 19-001722
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (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

  Baseline to week 8 visit 10

Secondary Outcomes (12)

• Change in Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) score

  Baseline to Week 8 visit 10

• Remission

  Baseline to Week 8 visit 10

• Change in General Anxiety Disorder 7-item scale score

  Baseline to Week 8 visit 10

• Response

  Baseline to Week 8 visit 10

• Change in Clinical Global Impression for Bipolar Disorder (CGI-BP) score

  Baseline to Week 8 visit 10

Study Arms (2)

Mydayis - Active

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Mydayis Extended-Release Capsule DRUG

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

Also known as: d-amphetamine / l-amphetamine

Mydayis - Active

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Lindner Center of HOPE: collaborator

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Lindner Center of Hope

Mason, Ohio, 45040, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Dextroamphetamine; Amphetamine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Mark A Frye

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study subjects will be randomized to receive MYDAYIS® or placebo on a 1:1 ratio according to computer-generated coding. Each site will have its own randomization list. Allocation concealment will be achieved by having the research pharmacy perform the randomization, package the study medication, and maintain the integrity of the blinded information throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: January 22, 2020
• Study Start: July 17, 2020
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)