Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study

Fleischhacker, W. Wolfgang; Sanchez, Raymond; Perry, Pamela; Jin, Na; Peters-Strickland, Timothy; Johnson, Brian R.; Baker, Ross A.; Eramo, Anna; McQuade, Robert D.; Carson, William H.; Walling, David; Kane, John M.

doi:10.1192/bjp.bp.113.134213

Cited by 131 publications

(223 citation statements)

References 23 publications

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“…[15][16][17] The greater improvement observed in the PANSS total score associated with aripiprazole lauroxil 882 mg compared to aripiprazole lauroxil 441 mg in the subpopulation of more severe patients (mean [SD] PANSS score > 92 at baseline, 101.3 [6.0] for aripiprazole lauroxil 441 mg and 101.0 [6.4] for aripiprazole lauroxil 882 mg) suggests there may potentially be an additional benefit of the higher dose in patients experiencing more severe symptoms.…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Double-Blind, Placebo-Controlled Trial of Aripiprazole Lauroxil in Acute Exacerbation of Schizophrenia

Meltzer¹,

Risinger²,

Nasrallah³

et al. 2015

J. Clin. Psychiatry

100

107

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Section: Discussionmentioning

confidence: 99%

A Randomized, Double-Blind, Placebo-Controlled Trial of Aripiprazole Lauroxil in Acute Exacerbation of Schizophrenia

Meltzer¹,

Risinger²,

Nasrallah³

et al. 2015

J. Clin. Psychiatry

100

107

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“…Treatment discontinuation in the AOM group was notably lower than in the placebo group, and almost all patients stayed on their starting dose of 400 mg. Safety and tolerability were generally as expected on the basis of previous studies of AOM in stable patients with schizophrenia. 13,14 Collectively, the results suggest that AOM 400 mg is a viable treatment option for patients who experience an acute exacerbation of schizophrenia.Drug names: aripiprazole once-monthly (Abilify Maintena), clozapine (Clozaril, FazaClo, and others). …”

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confidence: 98%

“…Another explanation may relate to patient demographics; ~ 66% of patients in the current study were African American compared with ~ 20% in previous AOM studies, and mean weight gain at 12 weeks was numerically greater in African American than in white patients. 13,14 Increased risk for obesity and weight gain has been observed in African Americans with severe mental illness. …”

mentioning

confidence: 99%

Aripiprazole Once-Monthly in the Acute Treatment of Schizophrenia

Kane

Peters-Strickland²,

Baker³

et al. 2014

J. Clin. Psychiatry

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Objective:To evaluate aripiprazole once-monthly (AOM), a long-acting injectable suspension of aripiprazole, as acute treatment in patients with schizophrenia (DSM-IV-TR).Method: Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo (October 2012-August 2013. The primary efficacy outcome was change from baseline to endpoint (week 10) in Positive and Negative Syndrome Scale (PANSS) total score. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale (PSP) scores. The study took place from October 2012 through August 2013. Results:Patients (N = 340; 79% male, 66% black) were randomized to AOM (n = 168) or placebo (n = 172). Least squares (LS) mean change from baseline to endpoint (week 10) favored AOM versus placebo in PANSS total (treatment difference, −15.1 [95% CI, −19.4 to −10.8]; P < .0001) and CGI-S (treatment difference, −0.8 [95% CI, −1.1 to −0.6]; P < .0001) scores, as it did at all other timepoints through 12 weeks (all P ≤ .0005). LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo (P < .0001). Common (> 10%) treatment-emergent adverse events (AOM vs placebo) were increased weight (16.8% vs 7.0%), headache (14.4% vs 16.3%), and akathisia (11.4% vs 3.5%). Conclusions:Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia, with acceptable safety and tolerability. These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode.Trial Registration: ClinicalTrials.gov identifier: NCT01663532 J Clin Psychiatry 2014;75(11):1254-1260 © Copyright 2014 Submitted: March 28, 2014; accepted July 8, 2014. Online ahead of print: August 19, 2014. Corresponding author: John M. Kane, MD, The Zucker Hillside Hospital, 75-59 263rd St, Kaufmann Bldg, Ste 103, Glen Oaks, NY 11004-1100 (jkane2@nshs.edu). O ral antipsychotics are effective for treating patients with schizophrenia; however, nonadherence to prescribed oral antipsychotic medication is common 1,2 and is associated with more hospitalizations, longer hospital stays, higher health care costs, 1 increased risk of suicide, and potential emergence of treatment resistance.3 Discontinuation of antipsychotic treatment is a strong predictor of relapse. 4 Compared with oral antipsychotics, long-acting injectables (LAIs) have been shown in naturalistic 5 and mirrorimage 6,7 studies to reduce rates of relapse and rehospitalization. Results from controlled trials and meta-analyses of such trials are mixed, 8,9 possibly reflecting methodological challenges in studying nonadherence in randomized controlled trials.Aripiprazole once-monthly (AOM), an extended-release injectable suspension for intramuscular use, is the first ...

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“…Moreover, for the majority of patients, ALAI study [28] reported absence of any pain, redness, swelling and induration following the first and last injections of aripiprazole 400 mg monthly.…”

Section: Discussionmentioning

confidence: 95%

Intramuscular Diffusion Status of Risperidone and Aripiprazole Long Acting Injectable (LAI) by Ultrasonography

Yasuhara¹,

Tanioka²,

Takase³

et al. 2016

OJPsych

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The aim of this study was to consider the characteristics of intramuscular diffusion status of risperidone and aripiprazole long acting injectable (LAI) by ultrasonography. Subjects were 40 adult subjects diagnosed with schizophrenia and treated with LAI [32 patients were risperidone LAI (RLAI) and 8 patients were aripiprazole LAI (ALAI)]. However, in this paper, only three cases (one RLAI case and 2 ALAI cases) were selected to illustrate the diffusion effects of both LAI. Dorsogluteal intramuscular (IM) injection sites were measured at prone position using the "double cross" method. Before LAI injection, the distance from the epidermis to the under-fascia (DEUF), and distance from the epidermis to the iliac bone (DEI) at the IM injection site were assessed by using ultrasonography: 1) the injection needle was inserted to the gluteus medius, and 2) observed the diffusion status within the muscle injected RLAI and ALAI were confirmed using the B-mode ultrasonography. Both RLAI and ALAI were depicted as high echogenicity with acoustic shadowing. It was considered that the diffusion states of LAIs by ultrasonography were important time course evaluations providing objective evidence.

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Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study

Abstract: Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole, and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg.

Cited by 131 publications

References 23 publications

A Randomized, Double-Blind, Placebo-Controlled Trial of Aripiprazole Lauroxil in Acute Exacerbation of Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled Trial of Aripiprazole Lauroxil in Acute Exacerbation of Schizophrenia

Aripiprazole Once-Monthly in the Acute Treatment of Schizophrenia

Intramuscular Diffusion Status of Risperidone and Aripiprazole Long Acting Injectable (LAI) by Ultrasonography

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