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

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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).