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

This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS\&#174; as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS \&#174; for this indication.


Eligibility Criteria:
Inclusion Criteria

1. Male or female between 18 and 55 years of age
2. Bipolar I or II disorder as confirmed by structured diagnostic interview by Axis I of the SCID by DSM-IV-TR.
3. 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.
4. 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.
5. Patients with a comorbid attention deficit disorder and binge eating disorder will be included.
6. Patients will be allowed to continue with their behavioral treatments (ie. CBT) targeted at their primary diagnosis.

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).