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 DisorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-003019-47-CZ
- Lead Sponsor
- Shire Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1700
· 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
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) a 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method