Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Phase 3TerminatedNCT01111565

Otsuka Pharmaceutical Development & Commercialization, Inc.137 enrolled

Overview

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 participants 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 participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant'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: * Screening Phase * Single-blind Prospective Treatment Phase * Single-blind Continuation Phase (Responder)or Double-blind Randomization Phase (non-Responder) * 30 day Post Treatment Follow-up Assigned Interventions: * Escitalopram monotherapy * Aripiprazole/Escitalopram combination therapy * Aripiprazole monotherapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

137

Conditions

Major Depressive Disorder (MDD)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration * Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period * Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase Exclusion Criteria: * Lack of prior treatment with an antidepressant during the current depressive episode * Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode. * Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode * Participants with epilepsy or significant history of seizure disorders * Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder * Participants who have received electroconvulsive therapy (ECT) in the last 10 years

Locations (53)

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Chino, California, United States

Unnamed facility

Riverside, California, United States

Unnamed facility

Torrance, California, United States

Unnamed facility

Hamden, Connecticut, United States

Unnamed facility

Outcomes

Primary Outcomes

Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.

Time frame: Week 8 to Week 14

Secondary Outcomes

Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C

CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses.

Time frame: Week 14

Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses.

Time frame: Week 8 to Week 14