NCT00105196 - A Study of Aripiprazole in Patients With Major Depressive Disorder | Crick | Crick

A Study of Aripiprazole in Patients With Major Depressive Disorder

Phase 3CompletedNCT00105196

Otsuka Pharmaceutical Development & Commercialization, Inc.349 enrolled

Overview

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

349

Conditions

Major Depressive Disorder

Interventions

Aripiprazole+ ADTDRUG

Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Placebo+ ADTDRUG

Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration. * Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.

Locations (34)

Outcomes

Primary Outcomes

Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)

Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Time frame: Baseline (Week 8) and Week 14

Secondary Outcomes

Mean Change in Sheehan Disability Scale (SDS) Mean Score

Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Time frame: Baseline (Week 8) and Week 14

Mean Change in SDS Item Score (Social Life)

Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Time frame: Baseline (Week 8) and Week 14

Mean Change in SDS Item Score (Family Life)

Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Time frame: Baseline (Week 8) and Week 14

Mean Change in SDS Item Score (Work/School)

Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Time frame: Baseline (Week 8) and Week 14

Data from ClinicalTrials.gov

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