PMID- 35235720
OWN - NLM
STAT- MEDLINE
DCOM- 20220502
LR  - 20220502
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 83
IP  - 2
DP  - 2022 Mar 1
TI  - Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc 
      Analysis of Short- and Long-Term Studies.
LID - 20m13793 [pii]
LID - 10.4088/JCP.20m13793 [doi]
AB  - Objective: To evaluate the short- and long-term effects of brexpiprazole on 
      patient functioning in schizophrenia. Methods: Data were included from three 
      6-week, randomized, double-blind, placebo-controlled studies (hospitalized 
      patients); a 52-week, randomized, double-blind, placebo-controlled maintenance 
      treatment study (terminated early by the study sponsor based on the positive 
      result of an interim analysis); and two 52-week, open-label extension studies-all 
      in patients with schizophrenia (DSM-IV-TR criteria) and conducted from July 
      2011-February 2016. Patients allocated to oral brexpiprazole received 2-4 mg/d 
      (short-term studies) or 1-4 mg/d (long-term studies). Functioning was measured 
      using the Personal and Social Performance (PSP) and Global Assessment of 
      Functioning (GAF) scales, with response defined as a PSP/GAF increase of >/= 10 
      points and remission as PSP score >/= 71 or GAF score >/= 61. Results: Patients 
      receiving brexpiprazole (n = 831) showed greater improvement than those receiving 
      placebo (n = 490) from baseline to week 6 in PSP score (least squares mean 
      difference, 3.20; 95% confidence interval, 1.82-4.58; P < .0001; Cohen d = 0.31) 
      and in all 4 PSP domains. At week 52 of the maintenance study (which had a low 
      completion rate primarily due to the early termination), GAF functional remission 
      was achieved by 65.3% (62/95) of stabilized patients randomized to brexpiprazole 
      and 47.1% (48/102) of stabilized patients randomized to placebo, with a number 
      needed to treat of 6 (95% confidence interval, 4-22; P = .0076). At week 52 of 
      the open-label studies (n = 177), PSP functional response and remission were 
      achieved by 84.2% and 41.8% of patients receiving brexpiprazole, respectively. 
      Conclusions: Although limited by the lack of an active comparator, analyses of 
      this large dataset demonstrate that brexpiprazole treatment is associated with 
      clinically relevant improvement in functioning among patients with schizophrenia, 
      in the short term and long term. Trial Registration: Data used in this post hoc 
      analysis were from studies with ClinicalTrials.gov identifiers: NCT01396421, 
      NCT01393613, NCT01810380, NCT01668797, NCT01397786, and NCT01810783.
CI  - (c) Copyright 2022 Physicians Postgraduate Press, Inc.
FAU - Correll, Christoph U
AU  - Correll CU
AD  - The Zucker Hillside Hospital, Department of Psychiatry, Glen Oaks, New York.
AD  - The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department 
      of Psychiatry and Molecular Medicine, Hempstead, New York.
AD  - Charite-Universitatsmedizin Berlin, corporate member of Freie Universitat Berlin, 
      Humboldt-Universitat zu Berlin, and Berlin Institute of Health, Department of 
      Child and Adolescent Psychiatry, Berlin, Germany.
AD  - Corresponding author: Christoph U. Correll, MD, The Zucker Hillside Hospital, 
      Psychiatry Research, 75-59 263rd St, Glen Oaks, NY 11004 
      (ccorrell@northwell.edu).
FAU - He, Ying
AU  - He Y
AD  - Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey.
FAU - Therrien, Francois
AU  - Therrien F
AD  - Otsuka Canada Pharmaceutical Inc, Saint-Laurent, Quebec, Canada.
FAU - MacKenzie, Erin
AU  - MacKenzie E
AD  - Lundbeck Canada Inc, Saint-Laurent, Quebec, Canada.
FAU - Meehan, Stine R
AU  - Meehan SR
AD  - H. Lundbeck A/S, Valby, Copenhagen, Denmark.
FAU - Weiss, Catherine
AU  - Weiss C
AD  - Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey.
FAU - Hefting, Nanco
AU  - Hefting N
AD  - H. Lundbeck A/S, Valby, Copenhagen, Denmark.
FAU - Hobart, Mary
AU  - Hobart M
AD  - Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT01396421
SI  - ClinicalTrials.gov/NCT01810380
SI  - ClinicalTrials.gov/NCT01810783
SI  - ClinicalTrials.gov/NCT01393613
SI  - ClinicalTrials.gov/NCT01397786
SI  - ClinicalTrials.gov/NCT01668797
SI  - ClinicalTrials.gov/NCT01396421
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220301
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Quinolones)
RN  - 0 (Thiophenes)
RN  - 2J3YBM1K8C (brexpiprazole)
SB  - IM
CIN - J Clin Psychiatry. 2022 Mar 1;83(2):. PMID: 35235717
MH  - *Antipsychotic Agents/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - *Quinolones/adverse effects
MH  - *Schizophrenia/chemically induced/drug therapy
MH  - Thiophenes/adverse effects
MH  - Treatment Outcome
EDAT- 2022/03/03 06:00
MHDA- 2022/05/03 06:00
CRDT- 2022/03/02 17:11
PHST- 2022/03/02 17:11 [entrez]
PHST- 2022/03/03 06:00 [pubmed]
PHST- 2022/05/03 06:00 [medline]
AID - 20m13793 [pii]
AID - 10.4088/JCP.20m13793 [doi]
PST - epublish
SO  - J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793.