Aripiprazole Once-Monthly in the Acute Treatment of Schizophrenia

Abstract

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 ...

Prevalence of polymorphisms in the ANKK1, DRD2, DRD3 genes and metabolic syndrome in refractory schizophrenia

“…Approximately 40% of people with schizophrenia do not present adequate response to drug treatment and persist with symptoms of the disease; they are known as refractory schizophrenic people 1 - 3 . Although there is no single, globally accepted consensus, refractory schizophrenia can be characterized by partial response, for at least five years, to three different types of antipsychotics (at least two with different chemical structures); intolerance to adverse effects; and relapses or symptomatic deterioration despite the use of appropriate doses of the drugs 3 - 4 .…”

“…Although there is no single, globally accepted consensus, refractory schizophrenia can be characterized by partial response, for at least five years, to three different types of antipsychotics (at least two with different chemical structures); intolerance to adverse effects; and relapses or symptomatic deterioration despite the use of appropriate doses of the drugs 3 - 4 . The atypical antipsychotic clozapine is considered the gold standard for the drug treatment of refractory schizophrenia, being associated with clinical improvement and decreased hospitalizations 4 - 5 .…”

Aripiprazole Once-Monthly in the Treatment of Acute Psychotic Episodes in Schizophrenia

“…10,11 The efficacy, safety, and tolerability of aripiprazole once-monthly 400 mg (AOM 400) for the treatment of acute exacerbation of psychotic symptoms in adult patients with schizophrenia were demonstrated previously. 12 Aripiprazole once-monthly 400 mg was superior to placebo based on change from baseline to week 10 in Positive and Negative Syndrome Scale (PANSS) total score, as well as PANSS positive and negative subscale scores. 12 …”

“…12 Aripiprazole once-monthly 400 mg was superior to placebo based on change from baseline to week 10 in Positive and Negative Syndrome Scale (PANSS) total score, as well as PANSS positive and negative subscale scores. 12 …”

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

“…Recently, a second generation antipsychotic is developed as a long-acting injection, in the form of a suspension of lyophilized aripiprazole reconstituted with an aqueous diluent, for intramuscular administration [8]. Aripiprazole LAI (ALAI), an extended-release injectable suspension for intramuscular use, is the first dopamine partial agonist available as an LAI and is approved for the treatment of schizophrenia [9] [10]. ALAI has a lower metabolic risk [11] and a lower risk for QT prolongation [12].…”