Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study.
Adolescent
Adult
Antipsychotic Agents
/ administration & dosage
Aripiprazole
/ administration & dosage
Brief Psychiatric Rating Scale
Canada
/ epidemiology
Cohort Studies
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prospective Studies
Schizophrenia
/ diagnosis
Schizophrenic Psychology
Treatment Outcome
Weight Gain
/ drug effects
Young Adult
Adherence
Aripiprazole once-monthly
Global functioning
Long acting injectable antipsychotics
Schizophrenia
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
16 04 2019
16 04 2019
Historique:
received:
23
11
2018
accepted:
04
04
2019
entrez:
18
4
2019
pubmed:
18
4
2019
medline:
22
1
2020
Statut:
epublish
Résumé
With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada. Following their clinicians' decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed. A majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p < 0.001) after adjusting for baseline GAF score, with a change in mean GAF scores from 49 at baseline to 61 at 12 months. No differences between early vs late phase were observed. Results on secondary outcome measures of function (Social and Occupational Functioning Scale) and illness severity (Clinical Global Impression-Severity Scale and Brief Psychiatric Rating Scale) were similar. Serious ADRs were observed in 29 (14.6%) patients and akathisia in 18 (9.1%) patients. At month-12, significant (≥7%) weight gain was observed in 25.7% (n = 27/105) of patients. Treatment with AOM is effective in improving symptoms and functioning in schizophrenia patients treated in regular clinical settings. Akathisia was infrequent while one quarter of patients gained clinically significant weight. Unique identifier: NCT02131415 . First posted: 06 May 2014.
Sections du résumé
BACKGROUND
With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada.
METHODS
Following their clinicians' decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed.
RESULTS
A majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p < 0.001) after adjusting for baseline GAF score, with a change in mean GAF scores from 49 at baseline to 61 at 12 months. No differences between early vs late phase were observed. Results on secondary outcome measures of function (Social and Occupational Functioning Scale) and illness severity (Clinical Global Impression-Severity Scale and Brief Psychiatric Rating Scale) were similar. Serious ADRs were observed in 29 (14.6%) patients and akathisia in 18 (9.1%) patients. At month-12, significant (≥7%) weight gain was observed in 25.7% (n = 27/105) of patients.
CONCLUSIONS
Treatment with AOM is effective in improving symptoms and functioning in schizophrenia patients treated in regular clinical settings. Akathisia was infrequent while one quarter of patients gained clinically significant weight.
TRIAL REGISTRATION
Unique identifier: NCT02131415 . First posted: 06 May 2014.
Identifiants
pubmed: 30991969
doi: 10.1186/s12888-019-2103-x
pii: 10.1186/s12888-019-2103-x
pmc: PMC6469112
doi:
Substances chimiques
Antipsychotic Agents
0
Aripiprazole
82VFR53I78
Banques de données
ClinicalTrials.gov
['NCT02131415']
Types de publication
Journal Article
Multicenter Study
Pragmatic Clinical Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
114Références
Can J Psychiatry. 2013 May;58(5 Suppl 1):14S-22S
pubmed: 23945063
Int Clin Psychopharmacol. 2017 Sep;32(5):235-248
pubmed: 28430670
Br J Psychiatry Suppl. 1998;172(33):53-9
pubmed: 9764127
Can J Psychiatry. 2013 May;58(5 Suppl 1):23S-9S
pubmed: 23945064
Br J Psychiatry Suppl. 1994 Apr;(23):29-38
pubmed: 8037899
Schizophr Res. 2018 Feb;192:205-210
pubmed: 28433498
J Clin Psychiatry. 2014 Jun;75(6):e566-72
pubmed: 25004197
Adv Ther. 2017 May;34(5):1036-1048
pubmed: 28382557
CNS Drugs. 2007;21(6):441-8
pubmed: 17521224
Schizophr Res. 2016 Jul;174(1-3):120-125
pubmed: 27157800
J Psychopharmacol. 2015 Aug;29(8):910-22
pubmed: 25999398
Drugs. 2004;64(15):1715-36
pubmed: 15257633
Psychol Med. 2008 Nov;38(11):1585-93
pubmed: 18205969
Schizophr Res. 2012 Aug;139(1-3):116-28
pubmed: 22658527
Br J Psychiatry. 2010 Nov;197(5):350-6
pubmed: 21037211
Pharmacoeconomics. 2017 Sep;35(9):921-936
pubmed: 28534254
Curr Med Res Opin. 2005 Dec;21(12):2017-28
pubmed: 16368053
Curr Med Res Opin. 2016;32(3):441-52
pubmed: 26713457
CNS Drugs. 2016 Aug;30(8):689-701
pubmed: 27255405
Am J Psychiatry. 2005 Mar;162(3):441-9
pubmed: 15741458
Acta Psychiatr Scand Suppl. 2003;(416):16-23
pubmed: 12755850
Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56
pubmed: 15000267
Psychopharmacol Bull. 1988;24(1):122-4
pubmed: 3387516
Ther Adv Psychopharmacol. 2014 Oct;4(5):198-219
pubmed: 25360245
Br J Psychiatry. 2014 Aug;205(2):135-44
pubmed: 24925984
Curr Treat Options Psychiatry. 2017;4(2):117-126
pubmed: 28580230
Acta Psychiatr Scand. 1994 Nov;90(5):342-7
pubmed: 7872038
J Med Econ. 2013 Jul;16(7):917-25
pubmed: 23663091
Expert Opin Pharmacother. 2016;17(3):395-407
pubmed: 26864352
Schizophr Res. 2015 Oct;168(1-2):498-504
pubmed: 26232241
Am J Psychiatry. 1992 Sep;149(9):1148-56
pubmed: 1386964
Expert Opin Drug Deliv. 2016;13(2):253-64
pubmed: 26636244
Schizophr Bull. 2003;29(2):325-40
pubmed: 14552507
J Clin Psychopharmacol. 2004 Aug;24(4):429-36
pubmed: 15232335
Can J Psychiatry. 2013 May;58(5 Suppl 1):30S-5S
pubmed: 23945065
Acta Psychiatr Scand. 2006 Feb;113(2):148-53
pubmed: 16423167
J Clin Psychopharmacol. 2017 Jun;37(3):347-350
pubmed: 28383362