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This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Major Depressive Disorder
ALKS 5461, Placebo
Alkermes Investigational Site
Published on BioPortfolio: 2014-08-27T04:00:30-0400
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
This study will evaluate the efficacy and safety of ALKS 5461.
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
This study will evaluate the abuse potential of ALKS 5461.
This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.
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A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA).
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.
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