Status:
COMPLETED
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Lead Sponsor:
Shire
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible p...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
- Subject is between 18 and 65 years of age.
- Subject has a primary diagnosis of non-psychotic MDD.
- Subject has a MADRS total score \>/=24.
- Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
- Subject, who is female, must have a negative serum beta human chorionic gonadotropin (B-HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements of the protocol.
- Subject is able to swallow a capsule.
- Exclusion Criteria:
- Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents.
- Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
- Subject has a current co-morbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms.
- Subject has been hospitalized (within the last 12 months) for their current MDD episode.
- Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
- Subject has a first degree relative that has been diagnosed with bipolar I disorder.
- Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
- Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
- Subject has a concurrent chronic or acute illness or unstable medical condition.
- Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions.
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
- Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject has glaucoma.
- Subject has any clinically significant ECG or clinical laboratory abnormalities.
- Subject has a history of moderate to severe hypertension.
- Current use of any other medications (including over-the-counter \[OTC\], herbal or homeopathic preparations) that have central nervous system effects.
- Subject has the potential need to initiate or modify frequency of psychotherapy or to continue or initiate other treatments for depression, outside of those allowed in this protocol.
- Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior to the Lead-in Baseline Visit.
- The subject has a known or suspected intolerance or hypersensitivity to the investigational product.
- The subject has a known or suspected intolerance, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl).
- Subject has a positive urine drug result.
- Subject has a body mass index (BMI) of \<18.5 or \>40.
- Subject is female and is pregnant or nursing.
Exclusion
Key Trial Info
Start Date :
October 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2013
Estimated Enrollment :
1105 Patients enrolled
Trial Details
Trial ID
NCT01436162
Start Date
October 19 2011
End Date
December 10 2013
Last Update
June 9 2021
Active Locations (101)
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1
ResearchOne, Inc.
Scottsdale, Arizona, United States, 85251
2
K&S Professional Research Services, LLC
Little Rock, Arkansas, United States, 72201
3
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
4
Diligent Clinical Trials
Downey, California, United States, 90241