A Study to Assess the Effectiveness and Safety of MYDAYIS® (d-amphetamine / l-amphetamine) Versus a Placebo for Bipolar Depression

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of MYDAYIS® as an augmentation agent for bipolar depression.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female between 18 and 55 years of age.
  • Bipolar I or II disorder as confirmed by structured diagnostic interview by DSM-IV-TR.
  • Major depressive episode unresponsive to steady and stable (i.e., at least 4 weeks) mood stabilizers (lithium, valproate, lamotrigine) and/or atypical antipsychotic therapy, and non-psychotropic therapy.
  • Antidepressant therapy is allowed in the study with the exception of patients on lamotrigine mood stabilization monotherapy. Patients will be enrolled provided that any modifications to the anti-depressant can be tapered and discontinued at least two weeks prior to randomization.
  • Patients receiving psychotherapy will be allowed to be randomized provided therapy frequency does not change during the 8-week blinded phase.  
  • Symptom severity score on the Quick Inventory for Depressive Symptomatology – Clinician (QIDS-C16) ≥ 11, and the Clinical Global Impression for Bipolar Illness (CGI-BP) Depression Severity Scale ≥ 3.
  • Patients on stimulants for comorbid attention deficit disorder (ADHD) and/or binge eating disorder (BED) will be enrolled provided that the stimulant can be tapered and discontinued at least one week prior to randomization; symptom severity inclusion criteria 4.1.4 must be met again prior to randomization.
  • Ability to travel to campus in Rochester, Minnesota, for the assessment visits.  

Exclusion Criteria:

  • Inability to provide writte informed consent.
  • Inability to understand English.
  • Score less than  90% on comprehension assessment that reviews study goals.
  • Clinically significant signs of acute suicidality in the last 1-to-4 weeks from any of the following assessments:
    • Suicide attempt within the past year, as defined by the Columbia-Suicide Severity Scale:
      • Response of  ≥ 2  on question #12 of QIDS-C or QIDS-SR; 
      • Response = 3 on the SCID Module A-  #A19.
  • Suicide attempt within the past year, as defined by the Columbia-Suicide Severity Rating Scale and a Yes response on the Columbia-Suicide Severity Rating Scale (C-SSRS) on Question #4 (ideation with intent, but no plan) or Question #5 (ideation, intent, and plan).
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs);also, within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor.
  • Baseline Young Mania Rating Scale (YMRS) score ≥ 12.
  • Patients with active psychosis (measured by a score > 4 on YMRS question #8) or a diagnosis of schizophrenia, schizoaffective disorder, delusional, or schizophreniform disorder identified by structured clinical interview for DSM-IV-TR.
  • Active abuse or dependence of alcohol, opiates, or cannabis (nicotine dependence will be an exception) by structured clinical interview for DSM-IV-TR; patients meeting full remission for at least 3 months can be randomized.  
  • Positive toxicology screen for drugs of abuse (i.e.. cocaine, methamphetamine, opiates)
  • Positive toxicology screen for cannabis and a cannabis use disorder by structured clinical interview for DSM-IV-TR. Participants who use cannabis for recreational or medicinal purposes can be screened and potentially included in the study only if they agree to discontinue use and a second toxicology screen within 1-to-4 weeks later, and before randomization, proves to be negative. 
  • Known lifetime history of cocaine ormethamphetamine abuse or dependence identified by structured clinical interview for DSM-IV-TR.
  • Known lifetime history of stimulant prescription abuse.
  • Known lifetime history of stimulant-induced mania.
  • 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.
  • Chronic kidney disease (CKD) > stage IIIa (GFR 40-59).
  • Tourette syndrome.
  • Women who are pregnant, lactating or of child-bearing potential  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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Frye, M.D.

Open for enrollment

Contact information:

Monica Walton B.S.

(507)422-0689

Walton.Monica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available