Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

Exclusion Criteria

• •1. Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents.
• •2. Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
• •3. Subject has a current co-morbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms.
• •4. Subject has been hospitalized (within the last 12 months) for their current MDD episode.
• •5. Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
• •6. Subject has a first degree relative that has been diagnosed with bipolar I disorder.
• •7. Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
• •8. Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
• •9. Subject has a concurrent chronic or acute illness or unstable medical condition.
• •10. Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions.
• •11. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
• •12. Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit.
• •13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• •14. Subject has glaucoma.
• •15. Subject has any clinically significant ECG or clinical laboratory abnormalities.
• •16. Subject has a history of moderate to severe hypertension.
• •17. Current use of any other medications (including over-the-counter \[OTC\], herbal or homeopathic preparations) that have central nervous system effects.
• •18. Subject has the potential need to initiate or modify frequency of psychotherapy or to continue or initiate other treatments for depression, outside of those allowed in this protocol.
• •19. Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior to the Lead-in Baseline Visit.
• •20. The subject has a known or suspected intolerance or hypersensitivity to the investigational product.
• •21. The subject has a known or suspected intolerance, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl).
• •22. Subject has a positive urine drug result.
• •23. Subject has a body mass index (BMI) of \<18.5 or \>40.
• •24. Subject is female and is pregnant or nursing.