Efficacy and safety of adjunctive aripiprazole in major depressive disorder in older patients: a pooled subpopulation analysis.
OBJECTIVE
To evaluate the efficacy and safety of adjunctive aripiprazole compared with standard antidepressant therapy (ADT) for older patients with major depressive disorder (MDD) who demonstrated an incomplete response to standard antidepressant monotherapy.


METHODS
Data from three similar 14-week studies (an 8-week prospective ADT treatment phase and a 6-week randomized, double-blind phase) of aripiprazole augmentation were pooled for this post hoc analysis. Two age groups were defined: younger patients (aged 18-49 years) and older patients (aged 50-67 years). The older patient group was further divided into three subgroups: 50-55, 56-60, and 61-67 years. The efficacy endpoint was the mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from end of the prospective phase (Week 8) to endpoint (Week 14, last observation carried forward (LOCF)). Remission was defined as MADRS total score ≤10 at endpoint.


RESULTS
Four hundred and nine older patients (placebo, n = 198; aripiprazole, n = 211) and 679 younger patients (placebo, n = 341; aripiprazole, n = 338) were included in this analysis. Older patients receiving aripiprazole demonstrated significantly greater improvement in MADRS total score versus placebo at Week 14 (-10.0 vs. -6.4; p < 0.001; LOCF), similar to the improvement seen in younger patients. Remission rates were significantly higher with aripiprazole versus placebo in older (32.5% vs. 17.1%; p < 0.001) and younger (26.9% vs. 16.4%; p < 0.001) patients. Akathisia was the most common adverse event in both the older (17.1%) and younger (26.0%) patient groups.


CONCLUSIONS
Adjunctive aripiprazole was effective in improving depressive symptoms in older patients, 50-67 years, with MDD who have had an inadequate response to standard antidepressant medication.
Steffens
David C
DC
Duke University Medical Center, Durham, NC, USA. steff001@mc.duke.edu
Nelson
J Craig
JC
Eudicone
James M
JM
Andersson
Candace
C
Yang
Huyuan
H
Tran
Quynh-Van
QV
Forbes
Robert A
RA
Carlson
Berit X
BX
Berman
Robert M
RM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000928:Antidepressive Agents / 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; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole
Psychother Psychosom. 2001 Jul-Aug;70(4):221-5
11408842
Int J Geriatr Psychiatry. 2007 Oct;22(10):986-91
17340654
J Clin Psychiatry. 1999 Apr;60(4):256-9
10221288
Am J Geriatr Psychiatry. 2008 Jul;16(7):558-67
18591576
Prim Care Companion J Clin Psychiatry. 2009;11(6):344-52
20098527
J Affect Disord. 2008 Apr;107(1-3):145-54
17904226
J Clin Psychiatry. 2009 Feb;70(2):208-13
19210951
J Clin Psychopharmacol. 2009 Aug;29(4):362-7
19593176
Br J Psychiatry. 1979 Apr;134:382-9
444788
J Clin Psychiatry. 1990 Jan;51 Suppl:40-3
2404003
Am J Psychiatry. 2009 Sep;166(9):980-91
19687129
Soc Psychiatry Psychiatr Epidemiol. 1992 Mar;27(2):78-82
1594977
CNS Spectr. 2009 Apr;14(4):197-206
19407731
J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65
12634292
J Clin Psychiatry. 2007 Jun;68(6):843-53
17592907
J Clin Psychopharmacol. 2008 Apr;28(2):156-65
18344725