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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00905424

Public ClinicalTrials.gov record NCT00905424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00905424
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Shire
Industry
Enrollment
246 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 30, 2009 (Actual)
Primary completion
Aug 4, 2010 (Actual)
Completion
Aug 4, 2010 (Actual)
Last update posted
Jun 14, 2021

2009 – 2010

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Pharmacology Research Institute (PRI) Newport Beach California 92660 —
Affiliated Research Institute San Diego California 92108 —
Florida Clinical Research Center, LLC Bradenton Florida 34208 —
Gulfcoast Clinical Research Center Fort Myers Florida 33912 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32809 —
Atlanta Institute of Medicine & Research Atlanta Georgia 30328 —
Carman Research Smyrna Georgia 30080 —
Vince & Associates Clinical Research Overland Park Kansas 66212 —
Duke University Medical Center Durham North Carolina 27705 —
North Star Medical Research, LLC Middleburg Heights Ohio 44130 —
IPS Research Company Oklahoma City Oklahoma 73103 —
Summit Research Network Portland Oregon 97210 —
FutureSearch Clinical Trials, LP Austin Texas 78756 —
Northwest Clinical Research Center Bellevue Washington 98007 —
Summit Research Network (Seattle), LLC Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00905424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 14, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00905424 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →