A study to examine the study drug, SPD489, in subjects with major depressive disorder (MDD) who are taking certain types of antidepressants and continuing to have MDD symptoms.

• Conditions: Major Depressive Disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-003019-47-DE
• Lead Sponsor: Shire Development Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-31
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

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

Subject was randomized as an inadequate responder in the antecedent study, or not randomized but continues to demonstrate residual depressive symptoms (MADRS total score of =5) at the end of the antecedent study, and in the Investigator’s opinion has the potential to benefit from adjunctive pharmacologic treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1665
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Subject is considered a suicide risk in the opinion of the Investigator,
has previously made a suicide attempt within the past 3 years, or is
currently demonstrating active suicidal ideation.
Subject has any current co-morbid psychiatric disorder, either controlled
with medications prohibited in this study or uncontrolled and associated
with significant symptoms, which was not present or recognized at entry
into the antecedent study and would have been exclusionary in the
antecedent study.
A new onset or known history of serious cardiac problems that may
place them at increased vulnerability to the sympathomimetic effects of
a stimulant medication, a history of moderate to severe hypertension or
an average (of 3 readings) resting sitting systolic blood pressure
>139mmHg or an average (of 3 readings) diastolic blood pressure
>89mmHg at study entry, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified