Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.

Key facts

Study ID

NCT00905424

Run by

Shire

People needed

246

Starts

2009-07-30

Expected to finish

2010-08-04

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD

You may not qualify if…

• History of non-response to multiple antidepressants

Where it is running

• Pharmacology Research Institute (PRI) — Newport Beach, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Atlanta Institute of Medicine & Research — Atlanta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Vince & Associates Clinical Research — Overland Park, Kansas, United States
• Duke University Medical Center — Durham, North Carolina, United States
• North Star Medical Research, LLC — Middleburg Heights, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Summit Research Network — Portland, Oregon, United States
• FutureSearch Clinical Trials, LP — Austin, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Summit Research Network (Seattle), LLC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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