PMID- 27336044
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160623
LR  - 20220409
IS  - 2334-265X (Print)
IS  - 2334-265X (Electronic)
IS  - 2334-265X (Linking)
VI  - 1
DP  - 2015
TI  - Aripiprazole once-monthly 400 mg for long-term maintenance treatment of 
      schizophrenia: a 52-week open-label study.
PG  - 15039
LID - 10.1038/npjschz.2015.39 [doi]
AB  - BACKGROUND: Long-term maintenance treatment with an antipsychotic is often 
      required to prevent relapse and mitigate functional deterioration in patients 
      with schizophrenia. AIMS: This study assessed the long-term safety, tolerability, 
      and maintenance of the therapeutic effect of aripiprazole once-monthly 400 mg 
      (AOM 400) in patients with schizophrenia. METHODS: This 52-week, open-label study 
      included patients previously enrolled in 1 of 2 AOM 400 randomized controlled 
      trials (RCTs) and de novo patients. Safety endpoints included adverse events 
      (AEs), suicidality, extrapyramidal symptoms, injection-site pain, and clinically 
      relevant changes in clinical and laboratory values. The primary efficacy endpoint 
      was the percentage of stable patients at baseline who remained stable at the last 
      visit of the AOM 400 maintenance phase. All endpoints were assessed with 
      descriptive statistics; there were no formal planned statistical analyses. 
      RESULTS: Of 1,247 patients screened, 1,178 enrolled in the study (194 de novo and 
      984 patients from the RCTs) and 1,081 received maintenance treatment with AOM 
      400. The maintenance phase completion rate was 79.4% at 52 weeks. 
      Treatment-emergent AEs in ⩾5% of patients during open-label AOM 400 treatment 
      were headache (7.6%), nasopharyngitis (7.0%), anxiety (6.8%), and insomnia 
      (6.6%). There were no clinically relevant changes in safety parameters of 
      interest. Ninety-five percent of stable patients at baseline remained stable at 
      their last visit during the AOM 400 maintenance phase. CONCLUSIONS: The long-term 
      safety and tolerability profile of AOM 400 was comparable to the RCTs, and the 
      long-term therapeutic effect was maintained.
FAU - Peters-Strickland, Timothy
AU  - Peters-Strickland T
AD  - Global Clinical Development (CNS), Otsuka Pharmaceutical Development & 
      Commercialization, Inc. , Princeton, NJ, USA.
FAU - Baker, Ross A
AU  - Baker RA
AD  - CNS Global Medical Affairs, Otsuka Pharmaceutical Development & 
      Commercialization, Inc. , Princeton, NJ, USA.
FAU - McQuade, Robert D
AU  - McQuade RD
AD  - Global Medical, Regulatory Affairs and Alliances, Otsuka America Pharmaceutical 
      Inc. , Princeton, NJ, USA.
FAU - Jin, Na
AU  - Jin N
AD  - Biometrics, Otsuka Pharmaceutical Development & Commercialization, Inc. , 
      Rockville, MD, USA.
FAU - Eramo, Anna
AU  - Eramo A
AD  - Medical Affairs & Phase IV Clinical Affairs, Lundbeck LLC , Deerfield, IL, USA.
FAU - Perry, Pamela
AU  - Perry P
AD  - Global Clinical Development (CNS), Otsuka Pharmaceutical Development & 
      Commercialization, Inc. , Princeton, NJ, USA.
FAU - Johnson, Brian R
AU  - Johnson BR
AD  - Global Clinical Development (CNS), Otsuka Pharmaceutical Development & 
      Commercialization, Inc. , Princeton, NJ, USA.
FAU - Duca, Anna
AU  - Duca A
AD  - Global Clinical Development (CNS), Otsuka Pharmaceutical Development & 
      Commercialization, Inc. , Rockville, MD, USA.
FAU - Sanchez, Raymond
AU  - Sanchez R
AD  - Global Clinical Development (CNS), Otsuka Pharmaceutical Development & 
      Commercialization, Inc. , Princeton, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20151104
PL  - United States
TA  - NPJ Schizophr
JT  - NPJ schizophrenia
JID - 101657919
PMC - PMC4849461
COIS- TP-S, RAB, NJ, PP, BRJ, AD, and RS are employees of Otsuka Pharmaceutical 
      Development & Commercialization, Inc. RDM is an employee of Otsuka America 
      Pharmaceutical Inc. AE is an employee of Lundbeck LLC.
EDAT- 2015/01/01 00:00
MHDA- 2015/01/01 00:01
PMCR- 2015/11/04
CRDT- 2016/06/24 06:00
PHST- 2015/06/24 00:00 [received]
PHST- 2015/08/25 00:00 [revised]
PHST- 2015/09/14 00:00 [accepted]
PHST- 2016/06/24 06:00 [entrez]
PHST- 2015/01/01 00:00 [pubmed]
PHST- 2015/01/01 00:01 [medline]
PHST- 2015/11/04 00:00 [pmc-release]
AID - npjschz201539 [pii]
AID - 10.1038/npjschz.2015.39 [doi]
PST - epublish
SO  - NPJ Schizophr. 2015 Nov 4;1:15039. doi: 10.1038/npjschz.2015.39. eCollection 
      2015.