SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

Stopped early · Phase 3

Conditions studied: Major Depressive Disorder

In brief

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Key facts

Study ID

NCT01436175

Run by

Shire

People needed

1570

Starts

2012-02-27

Expected to finish

2014-03-27

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.

You may not qualify if…

• Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol

Where it is running

• ResearchOne, Inc. — Scottsdale, Arizona, United States
• Arkansas Psychiatric Clinical Research Trials, P.A. — Little Rock, Arkansas, United States
• South Coast Clinical Trials, Inc. — Anaheim, California, United States
• American Neuropsychiatric Research, Inc. — Carson, California, United States
• Catalina Research Institute, LLC — Chino, California, United States
• Shanti Clinical Trials — Colton, California, United States
• ATP Clinical Research — Costa Mesa, California, United States
• Clinical Innovation, Inc. — Costa Mesa, California, United States
• Diligent Clinical Trials — Downey, California, United States
• Synergy Clinical Research Center of Escondido — Escondido, California, United States
• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• UC, Irvine Child Development Center — Irvine, California, United States
• Irvine Center For Clinical Research — Irvine, California, United States
• Omega Clinical Trials, LLC — La Habra, California, United States
• Semel Institute for Neuroscience & Human Behavior at UCLA — Los Angeles, California, United States
• Pacific Research Partners — Oakland, California, United States
• North County Clinical Research — Oceanside, California, United States
• Pasadena Research Institute, LLC — Pasadena, California, United States
• Anderson Clinical Research — Redlands, California, United States
• BreakThrough Clinical Trials, LLC — San Bernardino, California, United States
• Affiliated Research Institute — San Diego, California, United States
• PCSD - Feighner Research — San Diego, California, United States
• Clinical Innovations, Inc. — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Birmingham Research Group — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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