PMID- 30039634
OWN - NLM
STAT- MEDLINE
DCOM- 20190506
LR  - 20210109
IS  - 1099-1166 (Electronic)
IS  - 0885-6230 (Print)
IS  - 0885-6230 (Linking)
VI  - 33
IP  - 10
DP  - 2018 Oct
TI  - Adjunctive brexpiprazole for elderly patients with major depressive disorder: An 
      open-label, long-term safety and tolerability study.
PG  - 1403-1410
LID - 10.1002/gps.4952 [doi]
AB  - OBJECTIVES: The objective of this study was to evaluate the long-term safety and 
      tolerability of flexible-dose brexpiprazole adjunct to antidepressant treatment 
      (ADT) in elderly patients with major depressive disorder (MDD). METHODS: Elderly 
      patients (>/=65 years) with MDD and inadequate response to >/=1 ADT during the 
      current episode were recruited to a 26-week, interventional, open-label study 
      (NCT02400346) at outpatient centers in the USA and Europe. All patients received 
      brexpiprazole 1 to 3 mg/day adjunct to their current ADT. Safety outcomes 
      included adverse events (AEs), movement disorder scales, and standard safety 
      assessments (vital signs, laboratory safety parameters, physical examination, 
      electrocardiograms). Exploratory efficacy outcomes included the Montgomery-Asberg 
      Depression Rating Scale (MADRS), Clinical Global Impressions-Severity of Illness 
      (CGI-S), and Social Adaptation Self-Evaluation Scale (SASS). RESULTS: Of the 132 
      treated patients, 88 (66.7%) completed the study and 44 (33.3%) withdrew, 
      including 24 who withdrew because of AEs (18.2%). Overall, 102 patients (77.3%) 
      experienced >/=1 treatment-emergent AE (TEAE), which were mostly mild or moderate 
      in severity. Treatment-emergent AEs with the highest incidence were fatigue 
      (15.2%) and restlessness (12.9%). The most common TEAE leading to withdrawal was 
      fatigue (3.0%). No consistent clinically relevant findings were seen with regard 
      to movement disorder scales or standard safety assessments. Mean (standard error) 
      efficacy score changes from baseline to week 26 were: MADRS total, -14.5 (0.9); 
      CGI-S, -1.8 (0.1); and SASS, 3.2 (0.5). CONCLUSIONS: Long-term (26-week) 
      treatment with adjunctive brexpiprazole was generally well tolerated in elderly 
      patients with MDD and inadequate response to prior ADT. Improvements were 
      observed in depressive symptoms and social functioning.
CI  - (c) 2018 The Authors. International Journal of Geriatric Psychiatry Published by 
      John Wiley & Sons Ltd.
FAU - Lepola, Ulla
AU  - Lepola U
AD  - Savon Psykiatripalvelu Oy, Kuopio, Finland.
FAU - Hefting, Nanco
AU  - Hefting N
AD  - H. Lundbeck A/S, Copenhagen, Denmark.
FAU - Zhang, Doris
AU  - Zhang D
AD  - H. Lundbeck A/S, Copenhagen, Denmark.
FAU - Hobart, Mary
AU  - Hobart M
AD  - Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02400346
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180723
PL  - England
TA  - Int J Geriatr Psychiatry
JT  - International journal of geriatric psychiatry
JID - 8710629
RN  - 0 (Antidepressive Agents)
RN  - 0 (Quinolones)
RN  - 0 (Thiophenes)
RN  - 2J3YBM1K8C (brexpiprazole)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Akathisia, Drug-Induced/etiology
MH  - Antidepressive Agents/adverse effects/*therapeutic use
MH  - Chemotherapy, Adjuvant
MH  - Depressive Disorder, Major/*drug therapy
MH  - Europe
MH  - Fatigue/etiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Quality of Life
MH  - Quinolones/adverse effects/*therapeutic use
MH  - Social Participation/psychology
MH  - Thiophenes/adverse effects/*therapeutic use
MH  - United States
PMC - PMC6175103
OTO - NOTNLM
OT  - adjunctive
OT  - brexpiprazole
OT  - depression
OT  - elderly
OT  - open-label
EDAT- 2018/07/25 06:00
MHDA- 2019/05/07 06:00
PMCR- 2018/10/08
CRDT- 2018/07/25 06:00
PHST- 2018/02/18 00:00 [received]
PHST- 2018/06/17 00:00 [accepted]
PHST- 2018/07/25 06:00 [pubmed]
PHST- 2019/05/07 06:00 [medline]
PHST- 2018/07/25 06:00 [entrez]
PHST- 2018/10/08 00:00 [pmc-release]
AID - GPS4952 [pii]
AID - 10.1002/gps.4952 [doi]
PST - ppublish
SO  - Int J Geriatr Psychiatry. 2018 Oct;33(10):1403-1410. doi: 10.1002/gps.4952. Epub 
      2018 Jul 23.