SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg; Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg; Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg; Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg; Antidepressant + Placebo
Intervention description: Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks; Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks; Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks; Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks; oral, once daily for 8 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Antidepressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1197.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)
      who are taking certain types of antidepressants but continue to have residual depression
      symptoms. The purpose of this study is to help answer the following questions:

        -  How safe is SPD489 for the supplemental treatment of depression and what are the side
           effects that might be related to it?

        -  Can SPD489 help patients with depression who are also taking an antidepressant?

        -  How much SPD489 should be given to patients with depression who are also taking an
           antidepressant?

        -  How does SPD489 compare to placebo in depressed patients who are also taking an
           antidepressant?
    

Eligibility criteria:

        Inclusion Criteria

          1. Subject is able to provide written, personally signed and dated informed consent to
             participate in the study before completing any study-related procedures.

          2. Subject is between 18-65 years of age.

          3. Subject has a primary diagnosis of non-psychotic MDD.

          4. Subject has a MADRS total score 24

          5. Subject is willing and has an understanding and ability to fully comply with study
             procedures and restrictions defined in this protocol.

          6. Subject, who is female, must have a negative serum beta human chorionic gonadotropin
             (HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any
             applicable contraceptive requirements.

          7. Subject is able to swallow a capsule.

        Exclusion Criteria

          1. Subject whose current episode of MDD has not responded to an adequate treatment
             regimen.

          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 comorbid 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 that may
             place them at increased vulnerability to the sympathomimetic effects of a stimulant
             medication.

         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 at the
             Screening Visit.

         16. Subject has a history of moderate to severe hypertension.

         17. Current use of any other medication (including over-the-counter [OTC], herbal or
             homeopathic preparations) that has central nervous system effects.

         18. Subject has the potential to 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 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 or hypersensitivity to any of the
             possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended
             release.

         22. Subject has a positive urine drug result.

         23. Subject has a body mass index of <18.5 or >40.

         24. Subject is female and is pregnant or nursing.

         25. Subject has participated in another clinical study involving SPD489/NRP104 or has
             previously used commercial lisdexamfetamine dimesylate.