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

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).