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Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD)

2014-07-23 21:09:25 | BioPortfolio

Summary

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.

Description

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

Assigned Interventions:

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)

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Major Depressive Disorder

Intervention

Escitalopram, Aripiprazole

Status

Not yet recruiting

Source

Otsuka Pharmaceutical Development & Commercialization, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:25-0400

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Medical and Biotech [MESH] Definitions

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.

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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).

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