PMID- 27781135
OWN - NLM
STAT- MEDLINE
DCOM- 20170612
LR  - 20220330
IS  - 2162-3279 (Electronic)
VI  - 6
IP  - 10
DP  - 2016 Oct
TI  - Adjunctive brexpiprazole in patients with major depressive disorder and anxiety 
      symptoms: an exploratory study.
PG  - e00520
LID - e00520
AB  - BACKGROUND: Major depressive disorder (MDD) with concurrent anxiety symptoms may 
      signal a difficult-to-treat patient. Brexpiprazole is a serotonin-dopamine 
      activity modulator: a partial agonist at 5-HT(1A) and dopamine D(2) receptors at 
      similar potency, and an antagonist at 5-HT(2A) and noradrenaline alpha(1B/2C) 
      receptors. The objective of this Phase IIIb study was to explore effectiveness, 
      safety, and tolerability of brexpiprazole adjunctive to antidepressant (ADT) 
      monotherapy in patients with MDD and anxiety symptoms (NCT02013531). METHODS: 
      Patients with MDD, Hamilton Anxiety Rating Scale (HAM-A) total score >/= 20, and 
      inadequate response to current ADT received open-label brexpiprazole 
      1-3 mg day(-1) (target dose 2 mg day(-1)) + ADT for 6 weeks. Efficacy endpoints 
      included change from baseline at Week 6 in Montgomery-Asberg Depression Rating 
      Scale (MADRS) total score, HAM-A total score, and Sheehan Disability Scale (SDS). 
      Safety and tolerability assessments included adverse events (AEs). RESULTS: Of 37 
      participants enrolled, 32 (86.5%) completed the study. Baseline mean (SD) MADRS 
      total score was 30.1 (5.1); mean HAM-A total score was 26.9 (5.0). Improvements 
      from baseline were observed at Week 6 for least squares mean change in MADRS 
      total score (-19.6, p < .0001 vs. baseline), HAM-A total score (-17.8, p < .0001) 
      and mean (SD) SDS mean score [-3.6 (2.6)]. Brexpiprazole was well tolerated. The 
      most frequent treatment-emergent AEs were increased appetite (13.5%) and 
      diarrhea, dry mouth, and dizziness (all 10.8%). CONCLUSIONS: These open-label 
      results support the anxiolytic effects of adjunctive brexpiprazole in the 
      treatment of patients with MDD.
FAU - Davis, Lori L
AU  - Davis LL
AD  - Veterans Affairs Medical Center Tuscaloosa AL USA; University of Alabama School 
      of Medicine Birmingham AL USA.
FAU - Ota, Ai
AU  - Ota A
AD  - Otsuka Pharmaceutical Co., Ltd. Tokyo Japan.
FAU - Perry, Pamela
AU  - Perry P
AD  - Otsuka Pharmaceutical Development & Commercialization, Inc. Princeton NJ USA.
FAU - Tsuneyoshi, Kana
AU  - Tsuneyoshi K
AD  - Otsuka Pharmaceutical Co., Ltd. Tokyo Japan.
FAU - Weiller, Emmanuelle
AU  - Weiller E
AD  - H. Lundbeck A/S Valby Denmark.
FAU - Baker, Ross A
AU  - Baker RA
AD  - Otsuka Pharmaceutical Development & Commercialization, Inc. Princeton NJ USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02013531
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20160724
PL  - United States
TA  - Brain Behav
JT  - Brain and behavior
JID - 101570837
RN  - 0 (Dopamine Agonists)
RN  - 0 (Psychotropic Drugs)
RN  - 0 (Quinolones)
RN  - 0 (Serotonin Agents)
RN  - 0 (Thiophenes)
RN  - 2J3YBM1K8C (brexpiprazole)
SB  - IM
MH  - Anxiety/*complications/*drug therapy
MH  - Depressive Disorder, Major/*complications/*drug therapy
MH  - Dopamine Agonists/adverse effects/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Least-Squares Analysis
MH  - Male
MH  - Middle Aged
MH  - Psychiatric Status Rating Scales
MH  - Psychotropic Drugs/adverse effects/*therapeutic use
MH  - Quinolones/adverse effects/*therapeutic use
MH  - Serotonin Agents/adverse effects/therapeutic use
MH  - Thiophenes/adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC5064333
OTO - NOTNLM
OT  - antidepressant treatments
OT  - anxiety
OT  - clinical trials
OT  - depression
OT  - mood disorders
EDAT- 2016/10/27 06:00
MHDA- 2019/03/21 06:00
PMCR- 2016/07/24
CRDT- 2016/10/27 06:00
PHST- 2015/10/12 00:00 [received]
PHST- 2016/04/01 00:00 [revised]
PHST- 2016/05/25 00:00 [accepted]
PHST- 2016/10/27 06:00 [pubmed]
PHST- 2019/03/21 06:00 [medline]
PHST- 2016/10/27 06:00 [entrez]
PHST- 2016/07/24 00:00 [pmc-release]
AID - BRB3520 [pii]
AID - 10.1002/brb3.520 [doi]
PST - epublish
SO  - Brain Behav. 2016 Jul 24;6(10):e00520. doi: 10.1002/brb3.520. eCollection 2016 
      Oct.