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Study identifier: NCT01436175 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Terminated

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

Condition: Major Depressive Disorder  ·  Sponsor: Shire

PhasePhase 3
Planned participants1570
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where212 locations · 14 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (212)

Birmingham Research GroupBirmingham, Alabama, United States
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, LLCChino, California, United States
Shanti Clinical TrialsColton, California, United States
ATP Clinical ResearchCosta Mesa, California, United States
Clinical Innovation, Inc.Costa Mesa, California, United States
Diligent Clinical TrialsDowney, California, United States
Synergy Clinical Research Center of EscondidoEscondido, California, United States
Collaborative Neuroscience Network, Inc.Garden Grove, California, United States

+ 200 more locations — full list on the registry record.

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