EUCTR2011-003006-25-EEActive, not recruitingNot Applicable
The SPD489-323, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant. - SPD489-323
Shire Development Inc0 sites1,034 target enrollmentStarted: July 17, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,034
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subject has a primary diagnosis of non-psychotic major depressive disorder (single or recurrent) as defined by the Structured Clinical Interview for DSM-IV-TR disorders – Axis-I (SCID-CT) that has lasted =8 weeks prior to the Screening Visit (Visit 1).
- •Subject has a Montgomery Asburg Depression Rating Scale (MADRS) total score =24 at the Lead-in Baseline Visit (Visit 2).
- •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 1012
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
Exclusion Criteria
- •- Subject whose current episode of MDD has not responded to an adequate treatment regimen (at least 6 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more approved single antidepressant agents. Any subject whose current episode of MDD has not responded to an approved adjunctive treatment strategy is to be excluded.
- •- Subject who has a lifetime history of treatment-resistant depression, defined as having not responded to adequate treatment (at least 8 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more treatment regimens, including, distinct classes of approved single antidepressant agents and adjunctive treatment strategies.
- •- 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 that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Excluded are: any significant Axis II disorders, any bipolar disorder, any current or lifetime psychosis, post-traumatic stress disorder, anorexia nervosa, and bulimia nervosa.
- •A 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 the Screening Visit (Visit 1) and/or Lead-in Baseline Visit (Visit 2), or 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.
Investigators
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