412-246-6111

 

Shire

SPD489 Study

 

  

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Current Studies

Depression:

* Insomnia & Depression

* Transcranial Magnetic Stimulation (TMS)

* New Medication Trial (ROCHE)

* Buprenorphine for TRD

* New Medication Trial (Shire)

Assessment Only:

* Emotion/Physiology

Bipolar Disorder:

* Quetiapine vs. Lithium

  
Purpose

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. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). 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 supplemental SPD489 help patients who still have residual depression symptoms while 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?
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant

Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

 

For further information please call 412-246-6111, click here to email us, or visit clinicaltrials.gov.

 

  
 

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This website was last updated 06/14/2012.

© 2005 Mood Disorders Treatment and Research Program (MDTRP), Department of Psychiatry, Western Psychiatric Institute and Clinic (WPIC), UPMC Health System