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Effect of adjunctive aripiprazole in achieving various levels of response and on domains of functioning in MDD: A pooled analysis

Published online by Cambridge University Press:  16 April 2020

R. Gismondi
Affiliation:
Bristol-Myers Squibb, Rome, Italy
Z. Cain
Affiliation:
Bristol-Myers Squibb, Plainsboro, NJ
T. Fabian
Affiliation:
Western Psychiatric Institute and Clinic, Pittsburgh, PA
L. Rollin
Affiliation:
Bristol-Myers Squibb, Wallingford, CT
R. Forbes
Affiliation:
Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ
R. Berman
Affiliation:
Bristol-Myers Squibb, Wallingford, CT
R. Baker
Affiliation:
Bristol-Myers Squibb, Plainsboro, NJ
D. Casey
Affiliation:
Oregon Health & Science University, Portland, OR, USA
K. Laubmeier
Affiliation:
Bristol-Myers Squibb, Plainsboro, NJ
S.V. Marler
Affiliation:
Bristol-Myers Squibb, Wallingford, CT
J.-Y. Loze
Affiliation:
Otsuka Pharmaceutical, Paris, France

Abstract

Introduction

Major Depressive Disorder (MDD) patients experience different levels of response and functionality impairments.

Objectives/aims

Evaluate levels of response for adjunctive aripiprazole therapy (AA) and effects of AA on patient functioning.

Methods

Data were pooled from three similar, randomized, double-blind, placebo-controlled trials with aripiprazole in MDD. Quartile response categories were defined by reduction (%) in MADRS >6 weeks of treatment: Minimal response (≤25%), Partial response (>25% to < 50%), Moderate response (≥50% to < 75%), and Robust response (≥75%). Proportions of placebo (AP) vs. AA patients achieving a response were compared (Cochran-Mantel-Haenszel test) for each category. Functionality was assessed using mean changes in Sheehan Disability Scale (SDS) scores. Changes in scores were compared (ANCOVA) between AA and AP.

Results

AA had more patients (%) compared with AP achieving partial (23.9% vs. 17.9%, p = 0.017), moderate (23.1% vs. 15.0%, p< 0.001), and robust responses (14.3% vs. 7.4%, p< 0.001). AA had less (%) achieving minimal response compared with AP (38.7% vs. 59.6%, p< 0.001). Mean changes are below.

[Mean changes in SDS and domain scores]

Conclusions

Most inadequate responders who continued on AP were minimal responders (60%). 60% of aripiprazole patients rapidly achieved partial, moderate or robust response status. AA significantly improved social and family life domains of functioning.

Type
P02-35
Copyright
Copyright © European Psychiatric Association 2011
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