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This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the subject's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the subject's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.
The study will be organized as follows:
Phase A (Screening Phase) Phase B (Single-blind Prospective Treatment Phase) Phase B+ (Single-blind Phase B Responder) Phase C (Double-blind Randomization Phase) Follow-up
Phase B and Phase B+: Escitalopram monotherapy (10 mg or 20 mg) Phase C: Aripiprazole/Escitalopram combination therapy (3 mg/10 mg, 3 mg/20 mg, 6 mg/10 mg, 6 mg/20 mg, 12 mg/10 mg or 12 mg/20 mg); Aripiprazole monotherapy (3 mg, 6 mg or 12 mg); or Escitalopram monotherapy (10 mg or 20 mg)
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Major Depressive Disorder
Not yet recruiting
Otsuka Pharmaceutical Development & Commercialization, Inc.
Published on BioPortfolio: 2014-07-23T21:09:25-0400
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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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