Trial reportThe Journal of clinical psychiatry2015
A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia.
Trial report in The Journal of clinical psychiatry, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01469039 (A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia), which is not on this map. Cited by 50 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
Who cites it
50 citing papers in PubMed, 7 syntheses or guidelines pooled it, 114 citations in OpenAlex.
- Positive and Negative Symptoms Changes in Schizophrenia Patients on Antipsychotic Treatment: a Systematic Review and Dose-Response Meta-analysis.Schizophrenia bulletin · 2026Pooled it
- Antipsychotic-Related Prolactin Changes: A Systematic Review and Dose-Response Meta-analysis.CNS drugs · 2025Pooled it
- Adverse effects of antipsychotics on sleep in patients with schizophrenia. Systematic review and meta-analysis.Frontiers in psychiatry · 2023Pooled it
- Antipsychotic-Induced Weight Gain: Dose-Response Meta-Analysis of Randomized Controlled Trials.Schizophrenia bulletin · 2022Pooled it
- New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021Pooled it
- Long-Acting Injectable (LAI) Aripiprazole Formulations in the Treatment of Schizophrenia and Bipolar Disorder: a Systematic Review.Clinical drug investigation · 2019Pooled it
- Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation).The Cochrane database of systematic reviews · 2018Pooled it
- Trial
- Trial
- A Population Pharmacokinetic and Pharmacodynamic Analysis of RP5063 Phase 2 Study Data in Patients with Schizophrenia or Schizoaffective Disorder.European journal of drug metabolism and pharmacokinetics · 2018Trial
- Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia.Journal of clinical psychopharmacology · 2018Trial
- Initial Clinical Experience of RP5063 Following Single Doses in Normal Healthy Volunteers and Multiple Doses in Patients with Stable Schizophrenia.Clinical and translational science · 2018Trial
- Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.CNS drugs · 2017Trial
- Effect of Alkyl Chain Length on Physicochemical and Pharmacokinetic Performance of Aripiprazole Fatty Acid Prodrugs for Long-Acting Injectable Suspensions.Pharmaceutics · 2026Article
- Scoping review of the role of pharmacometrics in model-informed drug development.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Choosing among the long-acting injectable antipsychotics: an evidence-based pragmatic guide.CNS spectrums · 2025Review
- Optimising Aripiprazole Long-Acting Injectable: A Comparative Study of One- and Two-Injection Start Regimens in Schizophrenia with and Without Substance Use Disorders and Relationship to Early Serum Levels.International journal of molecular sciences · 2025Article
- Aripiprazole Lauroxil Every 2 Months or Paliperidone Palmitate Monthly for Acute Schizophrenia: A Post Hoc Analysis of PANSS Five-Factor Scores in the ALPINE Trial.Neuropsychiatric disease and treatment · 2025Article
- Aripiprazole Lauroxil: Development and Evidence-Based Review of a Long-Acting Injectable Atypical Antipsychotic for the Treatment of Schizophrenia.Neuropsychiatric disease and treatment · 2025Review
- Long-Acting Injectable Second-Generation Antipsychotics in Seriously Ill Patients with Schizophrenia: Doses, Plasma Levels, and Treatment Outcomes.Biomedicines · 2024Article
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study evaluated the efficacy, safety, and tolerability of aripiprazole lauroxil, a novel long-acting injectable atypical antipsychotic, for the treatment of schizophrenia.
methodAn international multicenter, randomized, double-blind, placebo-controlled trial was conducted between December 2011 and March 2014. Patients (N = 623) aged 18 to 70 years with schizophrenia (DSM-IV-TR criteria), experiencing an acute exacerbation, were randomized in a 1:1:1 ratio to receive gluteal intramuscular injection of aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, or matching placebo once monthly for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to day 85. The Clinical Global Impressions-Improvement scale (CGI-I) score at day 85 was the secondary efficacy outcome. Safety and tolerability were assessed.
resultsThe PANSS total score (mean ± standard error [SE]) improved significantly from baseline to day 85 in the aripiprazole lauroxil 441 mg and 882 mg groups, with placebo-adjusted differences of -10.9 ± 1.8 (P < .001) and -11.9 ± 1.8 (P < .001), respectively. Significant (P ≤ .004) improvements in both active treatment groups were demonstrated as early as day 8 and continued throughout the treatment period. The proportion of patients who were very much or much improved on the CGI-I was significantly greater with aripiprazole lauroxil 441 mg and 882 mg treatment versus placebo (P < .001). The most common treatment-emergent adverse events were insomnia, akathisia, headache, and anxiety. The incidence of injection site reactions was low, predominantly described as injection site pain, and was associated with the first injection.
conclusionsAripiprazole lauroxil demonstrated robust efficacy for treatment of patients experiencing acute exacerbation of schizophrenia. The improvement in psychotic symptoms was statistically significant and clinically meaningful. Symptom improvement occurred rapidly after initiation of aripiprazole lauroxil treatment and was maintained throughout the study. Both aripiprazole lauroxil 441 mg and 882 mg doses were well tolerated. These results support aripiprazole lauroxil as an important new treatment option for schizophrenia.
trial registrationClinicalTrials.gov identifier: NCT01469039; Clinicaltrialsregister.eu identifier: 2012-003445-15.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.