Global benefit-risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder.
OBJECTIVE
This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD).


METHODS
Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving ADT monotherapy and 366 patients receiving ADT and adjunctive aripiprazole (2-20 mg/day) were included. Efficacy measures included the Montgomery-Asberg depression rating scale (MADRS) Total score response (> or =50% reduction) and remission (response plus Total score < or = 10). Treatment-emergent adverse events were classified by severity. GBR ratio measures evaluated the relative benefit of adjunctive aripiprazole. Logistic regression models tested the effect of adjunctive aripiprazole on GBR and were used to identify predictors of net benefit and potential factors affecting the adjunctive aripiprazole treatment effect.


RESULTS
For MADRS-defined response and remission, the relative gain of adjunctive aripiprazole versus ADT monotherapy was 1.46 (p = 0.044) and 1.43 (p = 0.085), respectively. Gender, current escitalopram, duration of current episode, and baseline body mass index are potential factors affecting the adjunctive aripiprazole treatment effect.


CONCLUSIONS
Compared with ADT monotherapy, adjunctive aripiprazole was associated with an improved benefit-risk profile in MDD.
Wisniewski
Stephen R
SR
University of Pittsburgh, PA 15261, USA. wisniew@edc.pitt.edu
Chen
Chi-Chang
CC
Kim
Edward
E
Kan
Hong J
HJ
Guo
Zhenchao
Z
Carlson
Berit X
BX
Tran
Quynh-Van
QV
Pikalov
Andrei
A
D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016017:Odds Ratio; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole