Intramuscular Aripiprazole Research Articles

Reducing the use of high dose antipsychotic medication in acute adult inpatient psychiatric units

AimsTo evaluate the use of antipsychotics, and high dose antipsychotic treatment (HDAT) in psychiatric inpatient unitsBackgroundThe Royal College of Psychiatrists published a consensus statement on high dose antipsychotic medication in October 1993. Such treatment carries an increased risk of adverse effects including towards ventricular tachycardia and sudden death.MethodA retrospective case note review of all male patients on acute adult inpatient units in a psychiatric hospital in South Birmingham on a date in June 2018 (n = 45) including review of electronic patient records and prescriptions. This was compared with the results of an earlier study, with identical methods, undertaken in June 2015.Result•In both 2015 and 2018, only a minority of patients (20% and 11% respectively) were informal.•In both 2015 and 2018, the majority of inpatients had a diagnosis of schizophrenia (54% and 67%)•In both 2015 and 2018, 93% inpatients were prescribed antipsychotic medication.•In 2015, 56% patients were prescribed HDAT. This reduced in 2018 to 16%.•This reduction in use of HDAT was almost entirely due to a reduction in the prescription of PRN antipsychotic medication.•In terms of regularly prescribed antipsychotic medication, in both years, the most commonly prescribed drug was flupentixol, with a range of other second generation oral and long acting medications being prescribed, usually at doses within BNF limits.Between the two years, there was a substantial change in the prescribing of PRN antipsychotics. In 2015, 59% individuals were prescribed at least one PRN antipsychotic (27% were prescribed two). In 2018, this reduced to 40% prescribed at least one, and only 2% being prescribed 2 PRN antipsychotics. In both years, oral quetiapine was a common choice (39% patients in 2015 prescribed oral quetiapine, and 34% in 2018). In 2015, 39% patients were prescribed oral or intramuscular aripiprazole, while this reduced to 7% in 2018.ConclusionThe vast majority of psychiatric inpatients were being prescribed antipsychotic medication. Prescription of high dose antipsychotic medication was common in 2015, and this was largely attributable to high levels of prescribing of PRN antipsychotics. Following an educational programme for junior doctors and ward nurses, and the introduction of electronic prescribing, we achieved a significant change in practice, particularly in the prescribing of PRN antipsychotics, which has reduced our patients’ risk of receiving high dose antipsychotic medication.

Intramuscular Aripiprazole in the Therapy of Acute Mania for More than 24 hrs.

Intramuscular Aripiprazole in the Therapy of Acute Mania for More than 24 hrs.

Joint BAP NAPICU evidence-based consensus guidelines for the clinical management of acute disturbance: de-escalation and rapid tranquillisation

The British Association for Psychopharmacology and the National Association of Psychiatric Intensive Care and Low Secure Units developed this joint evidence-based consensus guideline for the clinical management of acute disturbance. It includes recommendations for clinical practice and an algorithm to guide treatment by healthcare professionals with various options outlined according to their route of administration and category of evidence. Fundamental overarching principles are included and highlight the importance of treating the underlying disorder. There is a focus on three key interventions: de-escalation, pharmacological interventions pre-rapid tranquillisation and rapid tranquillisation (intramuscular and intravenous). Most of the evidence reviewed relates to emergency psychiatric care or acute psychiatric adult inpatient care, although we also sought evidence relevant to other common clinical settings including the general acute hospital and forensic psychiatry. We conclude that the variety of options available for the management of acute disturbance goes beyond the standard choices of lorazepam, haloperidol and promethazine and includes oral-inhaled loxapine, buccal midazolam, as well as a number of oral antipsychotics in addition to parenteral options of intramuscular aripiprazole, intramuscular droperidol and intramuscular olanzapine. Intravenous options, for settings where resuscitation equipment and trained staff are available to manage medical emergencies, are also included.

Head-to-head comparison of 1-year aripiprazole long-acting injectable (LAI) versus paliperidone LAI in comorbid psychosis and substance use disorder: impact on clinical status, substance craving, and quality of life.

BackgroundTo overcome nonadherence in patients with psychosis switch to long-acting injectable (LAI) antipsychotic formulations is adopted. Most oral versus LAI comparisons showed similar antipsychotic responses. Psychoses often overlap with substance use disorder (SUD). Head-to-head LAI comparisons have hitherto focused only on non-comorbid populations.ObjectiveThe objective of this study was to compare two LAIs, administered for 12 months, in initially hospitalized patients with psychosis comorbid with SUD in their clinical and quality of life (QoL) outcomes.Patients and methodsInpatients were recruited during 2016 and switched randomly to 400 mg intramuscular aripiprazole monohydrate (AM) (N=50) or to 100 mg intramuscular paliperidone palmitate (PP) once-monthly (N=51); patients were discharged and followed up for 12 months. Patients were rated at baseline and after 1 year through the Clinical Global Impression scale – severity (CGIs), substance craving intensity was rated through a visual analog scale for substance craving, and QoL through the World Health Organization (WHOQOL-BREF) scale. We addressed confounders with backward stepwise logistic regression and three-way analysis of variance.ResultsPP were older and had more cases of schizophrenia spectrum and less bipolar disorders than AM, but AM had a stronger craving for substances at baseline. Both LAIs were associated with significant improvements in all outcomes, with AM displaying stronger effect sizes than PP. The two groups did not differ on baseline WHOQOL-BREF scores in any domain, but at the 1-year follow-up, AM fared better on all domains. The two groups did not differ in final severity, but PP scored higher than AM in craving at the 1-year endpoint.Limitation: The CGIs is not a refined tool for severity and the substance craving may be subject to recall bias.Conclusion1-year AM and PP was followed by improved clinical status and QoL and reduced substance craving in a population with psychosis and SUD comorbidity. AM, compared to PP, improved craving and QoL at the 1-year follow-up.

Joint BAP NAPICU evidence-based consensus guidelines for the clinical management of acute disturbance: De-escalation and rapid tranquillisation.

The British Association for Psychopharmacology and the National Association of Psychiatric Intensive Care and Low Secure Units developed this joint evidence-based consensus guideline for the clinical management of acute disturbance. It includes recommendations for clinical practice and an algorithm to guide treatment by healthcare professionals with various options outlined according to their route of administration and category of evidence. Fundamental overarching principles are included and highlight the importance of treating the underlying disorder. There is a focus on three key interventions: de-escalation, pharmacological interventions pre-rapid tranquillisation and rapid tranquillisation (intramuscular and intravenous). Most of the evidence reviewed relates to emergency psychiatric care or acute psychiatric adult inpatient care, although we also sought evidence relevant to other common clinical settings including the general acute hospital and forensic psychiatry. We conclude that the variety of options available for the management of acute disturbance goes beyond the standard choices of lorazepam, haloperidol and promethazine and includes oral-inhaled loxapine, buccal midazolam, as well as a number of oral antipsychotics in addition to parenteral options of intramuscular aripiprazole, intramuscular droperidol and intramuscular olanzapine. Intravenous options, for settings where resuscitation equipment and trained staff are available to manage medical emergencies, are also included.

PLACID study: A randomized trial comparing the efficacy and safety of inhaled loxapine versus intramuscular aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder

The aim of the study was to investigate the efficacy and safety of inhaled loxapine compared with the intramuscular (IM) antipsychotic aripiprazole in acutely agitated patients with schizophrenia or bipolar I disorder. PLACID was an assessor-blind, parallel-group trial conducted in 23 centres in the Czech Republic, Germany, Spain, and Russia. Patients (aged 18–65 years) diagnosed with schizophrenia or bipolar I disorder experiencing acute agitation (Clinical Global Impression [CGI]-Severity score ≥ 4) while hospitalized or attending an emergency room were randomized to receive up to two doses of inhaled loxapine 9.1 mg or IM aripiprazole 9.75 mg (≥ 2 h between doses) during the 24-h study period. The primary efficacy endpoint was time to response (CGI-Improvement score 1 [very much improved] or 2 [much improved]). The primary analysis included randomized patients who provided informed consent (full analysis set [FAS]); the safety analysis included all patients who received study medication. The FAS comprised 357 patients (enrolled December 2, 2014 – October 31, 2016). The between-treatment difference in median time to CGI-Improvement response was 10 min (95% CI 0.0–30.0); p = 0.0005) in favour of inhaled loxapine (median [95% CI]: 50 min [30.0–50.0] vs 60 min [50.0–90.0] with IM aripiprazole); the difference was significant at 10 min (responders: 14% [loxapine] vs 4% [aripiprazole]; p = 0.001). There were no safety issues. Inhaled loxapine reduced agitation faster than IM aripiprazole, supporting its use as a first-line option for managing acute agitation in patients with schizophrenia or bipolar disorder.

Evidence-Based Review of Pharmacotherapy for Acute Agitation. Part 1: Onset of Efficacy

BackgroundThe main goal of antipsychotic medication in the management of acute agitation in the emergency department is to rapidly induce calm without oversedation, enabling patients to participate in their own care. However, there is a paucity of comparative studies, particularly with newer fast-acting second-generation antipsychotic agents. Objective of the ReviewThis structured evidence-based review compared the onset of efficacy of antipsychotic treatments for acute agitation using data from randomized controlled trials identified by a literature search of the PubMed database. ResultsBased on findings from 28 blinded randomized controlled trials, onset of efficacy was rapid and generally observed at the first time point after intramuscular administration of ziprasidone (15−30 min) or olanzapine (15−30 min), but was more likely to be delayed with intramuscular haloperidol, even when combined with lorazepam (30−60 min), and intramuscular aripiprazole (45−90 min). When administered orally, rapid onset of efficacy was also consistently observed at the first assessment time point with olanzapine (15−120 min), risperidone (30−120 min), and sublingual asenapine (15 min). Significant effects were apparent for inhaled loxapine within 10−20 min. Effects were apparent within approximately 5−10 min with i.v. droperidol. Onset of efficacy was typically more rapid with second-generation antipsychotic agents than benzodiazepines, but data are limited. ConclusionsAlthough the patient populations of trials included in this review do not truly reflect that of the emergency department, the results provide useful information to emergency physicians on the rapid efficacy of certain newer-generation antipsychotic agents for the treatment of acutely agitated patients.

Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation).

People experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations. To evaluate the effects of intramuscular aripiprazole in the treatment of psychosis-induced aggression or agitation (rapid tranquillisation). On 11 December 2014 and 11 April 2017, we searched the Cochrane Schizophrenia Group's Study-based Register of Trials which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. All randomised controlled trials (RCTs) that randomised people with psychosis-induced aggression or agitation to receive either intramuscular aripiprazole or another intramuscular intervention. We independently inspected citations and, where possible, abstracts, ordered papers and re-inspected and quality assessed these. We included studies that met our selection criteria. At least two review authors independently extracted data from the included studies. We chose a fixed-effect model. We analysed dichotomous data using risk ratio (RR) and the 95% confidence intervals (CI). We analysed continuous data using mean differences (MD) and their CIs. We assessed risk of bias for included studies and used GRADE to create 'Summary of findings' tables. Searching found 63 records referring to 21 possible trials. We could only include three studies, all completed over the last decade, with 885 participants, of which 707 were included for quantitative analyses in this systematic review. Due to limited comparisons, small size of trials and a paucity of investigated and reported 'pragmatic' outcomes, evidence was mostly graded as low or very low quality. No trials reported useful data for one of our primary outcomes of tranquil or asleep by 30 minutes. Economic outcomes were also not reported in the trials.When compared with placebo, fewer people in the aripiprazole group needed additional injections compared to the placebo group (2 RCTs, n = 382, RR 0.69, 95% CI 0.56 to 0.85, very low-quality evidence). Clinically important improvement in agitation at two hours favoured the aripiprazole group (2 RCTs, n = 382, RR 1.50, 95% CI 1.17 to 1.92, very low-quality evidence). The numbers of non-responders after the first injection also favoured aripiprazole (1 RCT, n = 263, RR 0.49, 95% CI 0.34 to 0.71, low-quality evidence). Although no effect was found, more people in the aripiprazole compared to the placebo group experienced adverse effects (1 RCT, n = 117, RR 1.51, 95% CI 0.93 to 2.46, very low-quality evidence).Aripiprazole required more injections compared to haloperidol (2 RCTs, n = 477, RR 1.28, 95% CI 1.00 to 1.63, very low-quality evidence), with no significant difference in agitation (2 RCTs, n = 477, RR 0.94, 95% CI 0.80 to 1.11, very low-quality evidence), and similar non-responders after first injection (1 RCT, n = 360, RR 1.18, 95% CI 0.78 to 1.79, low-quality evidence). Aripiprazole and haloperidol did not differ when taking into account the overall number of people that experienced at least one adverse effect (1 RCT, n = 113, RR 0.91, 95% CI 0.61 to 1.35, very low-quality evidence).Compared to aripiprazole, olanzapine was better at reducing agitation (1 RCT, n = 80, RR 0.77, 95% CI 0.60 to 0.99, low-quality evidence) and had a more favourable effect on global state change scores (1 RCT, n = 80, MD 0.58, 95% CI 0.01 to 1.15, low-quality evidence), both at two hours. No differences were found in terms of experiencing at least one adverse effect during the 24 hours after treatment (1 RCT, n = 80, RR 0.75, 95% CI 0.45 to 1.24, very low-quality evidence). However, participants allocated to aripiprazole experienced less somnolence (1 RCT, n = 80, RR 0.25, 95% CI 0.08 to 0.82, low-quality evidence). The available evidence is of poor quality but there is some evidence aripiprazole is effective compared to placebo and haloperidol, but not when compared to olanzapine. However, considering that evidence comes from only three studies, caution is required in generalising these results to real-world practice. This review firmly highlights the need for more high-quality trials on intramuscular aripiprazole in the management of people with acute aggression or agitation.

Rationale and design of the PLACID study: a randomised trial comparing the efficacy and safety of inhaled loxapine versus IM aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder

BackgroundThe management of acute agitation manifesting in patients with schizophrenia or bipolar disorder requires swift pharmacological intervention to provide rapid symptomatic relief and prevent escalation to aggression and violence. Antipsychotic medications are widely used in this setting and the availability of an inhaled formulation with deep lung absorption of the antipsychotic loxapine has the potential to deliver a faster onset of therapeutic effect than the available intramuscular formulations of antipsychotics.MethodsThe efficacy of inhaled loxapine and the alternative antipsychotic aripiprazole delivered via intramuscular (IM) injection will be compared in the Phase IIIb PLACID study. Adults (18–65 years) with a confirmed diagnosis of schizophrenia or bipolar I disorder presenting with acute agitation will be randomly assigned to open-label treatment in a 1:1 ratio. Clinical evaluation will be conducted by raters blinded to treatment assignment. The primary efficacy endpoint is time to response (defined as a Clinical Global Impression of Improvement [CGI-I] score of 1 [very much improved] or 2 [much improved]).Secondary endpoints will include the percentage of responders at different time points after dosing; the proportion of patients who receive 1 or 2 doses of study drug; time to second dose; time to rescue medication; satisfaction with study drug (evaluated using Item 14 of the Treatment Satisfaction Questionnaire for Medication); and safety and tolerability. Approximately 360 patients will be recruited with an interim analysis conducted once 180 patients have completed the study to decide whether to stop for futility or continue with or without an increase in the sample size up to additional 288 patients.DiscussionThe PLACID trial will assess the efficacy and safety of inhaled loxapine with deep lung absorption compared with the IM antipsychotic, aripiprazole, in acutely agitated patients with schizophrenia or bipolar disorder. In the event that the median time to response of inhaled loxapine is significantly shorter than that of the intramuscular aripiprazole, the PLACID study has the potential to support the inhaled antipsychotic therapy as the standard of care in this setting.Trial registrationThe study protocol was registered with the European Clinical Trials Database on the 31 October 2014 (EudraCT number 2014–000456-29).

Effects of switching antipsychotics in 80 outpatients: A descriptive analysis from a mental health community

IntroductionIn the general practice, psychiatrists widely prescribe antipsychotics for several conditions as schizophrenia, bipolar disorder and behavioral disorders among others.Aim and objectivesThe aim of this study is to describe the clinical and sociodemographic features of typical patients receiving antipsychotics and their effects after switching to long-acting treatment.MethodsA descriptive analysis of 80 outpatients collected from a mental health clinic in Santander (Spain) was performed. All patients were taking antipsychotics at baseline, both oral and intramuscular, and were switched to a different long-acting antipsychotic drug.ResultsAt baseline, 24 patients were taking oral medication and 56 intramuscular. There were 37 females and 43 males. There were no gender differences in the final treatment, but Palmitate Paliperidone (71.3%) was the most prescribed drug, followed by intramuscular risperidone (16.3%) and long-acting aripiprazole (11.3%). We found gender differences regarding cannabis (P = 0.002), alcohol (P = 0.004) and tobacco (P = 0.043) consumption, being their use more common in males. In regard to diagnosis, schizophrenia was predominant in both gender groups, whereas delusional and behavioral disorders were more frequent in females. There were no significant differences in the reason of switching, but the inefficacy was more common in males and the side effects in females. At the switching, females were significantly older than males (P = 0.003). We found significant differences before and after switching regarding the number of admissions, emergency visits and length of stay.ConclusionsAntipsychotic benefits are individual and unpredictable. When switching, some other different factors should be taking in account, not only regarding medication.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Intramuscular olanzapine versus intramuscular aripiprazole for the treatment of agitation in patients with schizophrenia: A pragmatic double-blind randomized trial

ObjectiveTo evaluate and compare the effectiveness and adverse effects of intramuscular (IM) olanzapine and IM aripiprazole for the treatment of agitated patients with schizophrenia in clinical practice. MethodsA 24-hour randomized double-blind study carried out at a psychiatric hospital in Thailand enrolled adult patients (18–65years old) with schizophrenia experiencing agitation. Patients received one dose of IM olanzapine or IM aripiprazole followed by routine oral psychotropic medications. Efficacy was primarily measured using the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC). ResultsA total of 80 patients with a PANSS-EC score range of 22–35 entered the study, of whom 13% had a medical comorbidity and 40% a history of active substance abuse. The 40 patients receiving IM olanzapine showed greater improvement than the 40 patients receiving IM aripiprazole in PANSS-EC scores at 2h after the injection (p=0.002) but not at 24h. The two treatments were well tolerated. Patients receiving IM olanzapine experienced greater somnolence than those receiving IM aripiprazole. There were no clinically relevant changes in vital signs in either group. ConclusionThe results indicate that IM olanzapine and aripiprazole are similarly effective and well tolerated in the real-world treatment of agitation associated with schizophrenia over the first 24h. However, in the early hours, IM olanzapine may produce more sedation and reductions in agitation.

Dosing Recommendations of Aripiprazole Depot with Strong Cytochrome P450 3A4 Inhibitors: A Relapse Risk.

A 50-year-old male patient with comorbid human immunodeficiency virus developed a relapse of bipolar disorder after a switch from oral aripiprazole 10 mg/day to intramuscular aripiprazole depot 200 mg every 28 days plus oral aripiprazole 5 mg/day. The patient was concomitantly taking lopinavir, saquinavir, ritonavir, silybum marianum extract, and omeprazole. Only 1 week after the switch, the patient developed mood swings, irritability, depressive mood, and lack of drive. The oral aripiprazole was increased again to stabilize the patient. The measured trough drug concentration of aripiprazole was low and may be correlated to the relapse. When oral aripiprazole was increased back to 10 mg again, the depressive symptoms subsided. The dose of the next depot injection was increased to 300 mg and that of oral aripiprazole decreased back to 5 mg/day. Because trough drug concentrations were still low after 28 days, the depot dose was increased to 400 mg every 28 days, which is double that recommended in the prescriber’s information. Two months after the initial switch from oral to intramuscular aripiprazole, the patient’s mood stabilized on aripiprazole depot 400 mg every 28 days. More clinical data, especially regarding the pharmacokinetic drug interactions of aripiprazole depot are needed to improve dosing recommendations, and prevent relapses or adverse drug events. Genetic polymorphisms may play an important role in the clinical relevance of drug interactions concerning aripiprazole depot.

Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia.

This study aimed to evaluate the effects of aripiprazole lauroxil on hostility and aggressive behavior in patients with schizophrenia. Patients aged 18-70 years with a diagnosis of schizophrenia and currently experiencing an acute exacerbation or relapse were randomized to intramuscular (IM) aripiprazole lauroxil 441 mg (n=207), 882 mg (n=208), or placebo (n=207) for 12 weeks. In post-hoc analyses, hostility and aggression were assessed by the Positive and Negative Syndrome Scale (PANSS) Hostility item (P7) and a specific antihostility effect was assessed by adjusting for positive symptoms of schizophrenia, somnolence, and akathisia. The PANSS excited component score [P4 (Excitement), P7 (Hostility), G4 (Tension), G8 (Uncooperativeness), and G14 (Poor impulse control)], and the Personal and Social Performance scale disturbing and aggressive behavior domain were also assessed. Of the 147 patients who received aripiprazole lauroxil 882 mg and with a baseline PANSS Hostility item P7 more than 1, there was a significant (P<0.05) improvement versus placebo on the PANSS Hostility item P7 score by mixed-model repeated-measures at the end of the study, which remained significant when PANSS-positive symptoms and somnolence or akathisia were included as additional covariates. The proportion with PANSS Hostility item P7 more than 1 at endpoint was significantly (P<0.05) lower with aripiprazole lauroxil versus placebo (53.6, 46.1, and 66.3% for 441, 882 mg, and placebo). A significant (P<0.05) improvement was found with aripiprazole lauroxil versus placebo for change from baseline in the PANSS excited component score. The proportion of patients with aggressive behavior on the Personal and Social Performance scale was significantly (P<0.05) lower for aripiprazole lauroxil: 30.0% for 441 mg versus 44.1% for placebo (P=0.006) and 22.2% for 881 mg (P<0.001 versus placebo). Treatment with aripiprazole lauroxil resulted in decreases in agitation and hostility in patients with schizophrenia and this antihostility effect appears to be independent of a general antipsychotic effect.

P.3.b.019 Intramuscular versus oral aripiprazole in the management of acute patients, with and without substance abuse: a natural study

P.3.b.019 Intramuscular versus oral aripiprazole in the management of acute patients, with and without substance abuse: a natural study

Management of psychosis and agitation in medical-surgical patients who have or are at risk for prolonged QT interval.

We review the literature on management of psychosis and agitation in medical-surgical patients who have or are at risk for prolonged QT interval, a risk factor for torsade de pointes (TdP), and we describe our protocols for treating these patients. We searched PubMed and PsycInfo for relevant studies and found few papers describing options for treating psychosis and agitation in these patients. Prolonged QTc interval has been more often associated with low-potency phenothiazines such as thioridazine; however, it may occur with high potency typical antipsychotics such as fluphenazine and haloperidol as well as with atypical antipsychotics such as quetiapine, risperidone, olanzapine, iloperidone, and particularly ziprasidone. Antipsychotics for which no association with prolonged QTc interval has been shown include lurasidone, clozapine, and aripiprazole. For patients who have risk factors for prolonged QTc interval but whose electrocardiograms do not show this, reasonable first choices include oral or intramuscular olanzapine or aripiprazole, followed by risperidone and quetiapine or oral or intramuscular haloperidol. For those who have prolonged QTc but that measures less than 500 ms, we limit the use of antipsychotics to aripiprazole, olanzapine, risperidone, or quetiapine. Finally, for patients who have a QTc of 500 ms or greater, we rely on aripiprazole, valproate, trazodone, and benzodiazepines.

Intramuscular Aripiprazole in the Acute Management of Psychomotor Agitation

To assess acute efficacy and safety of 9.75 mg of intramuscular (IM) injections of the atypical antipsychiatric aripiprazole in patients with schizophrenia or bipolar disorder and acute agitation. Open-label trial of IM injections of aripiprazole and 24-hour monitoring of clinical response in patients with major psychoses and acute agitation. Partial analysis of blood levels of the administered drug to correlate with clinical response. Acute psychiatric care wards in a single university hospital. A total of 201 acutely agitated patients (79 with schizophrenia and 122 with bipolar disorder I). Aripiprazole 9.75 mg IM injection. We evaluated clinical response using the Excitatory Component of the Positive and Negative Syndrome Scale (PANSS-EC), the Agitation/Calmness Evaluation Scale (ACES), and the Clinical Global Impressions scale (CGI). Assessments were conducted 30, 60, 90, and 120 minutes and 24 hours after the first injection for PANSS-EC and ACES, and 2, 4, 6, and 24 hours for CGI. Response was at least a 40% decrease in PANSS-EC scores. We measured serum aripiprazole and dehydroaripiprazole levels in a subsample. IM aripiprazole significantly improved clinical measures. PANSS-EC improved progressively, starting after 30 minutes. ACES improved after 90 minutes and continued thereafter. Effects were sustained, with steadily decreasing CGI scores, until the 24th hour. Response rate was 83.6% after 2 hours, but with repeat injections, it rose to over 90% with no differences among diagnostic groups. Although there were gender differences in the response to individual PANSS-EC items, the responses were similar overall. Neither clinical monitoring nor patient reporting revealed any side effects. No therapeutic window was identified, and levels did not correlate with any clinical measure. Aripiprazole was effective and safe in reducing acute agitation in patients with bipolar disorder or schizophrenia. Our results compare favorably to double-blind trials, probably due to higher expectations in trials involving no placebo arm. Absence of side effects could be related to the short observation time.

Consensus statement on the use of intramuscular aripiprazole for the rapid control of agitation in bipolar mania and schizophrenia

As much as the ideal treatment goal for severe mental illnesses such as bipolar disorder and schizophrenia is to prevent or delay the recurrence or relapse of acute episodes, when the patient presents with an acute episode, the goal should be to manage behavioural symptoms, and return to prior levels of symptomatic control. In a serious mental illness, the management of the acutely agitated state may require rapid tranquillisation (RT) to control violent and/or disturbed behaviour when all other methods of de-escalation have failed. Current clinical practice guidelines for emergency interventions in the case of acutely disturbed behaviours favour calming the patient by reducing agitation with mild sedation, but not sleep, to allow continued interaction with the patient, to ensure an accurate diagnosis, and to enable patients to be actively engaged in treatment decisions. Pharmacotherapy is an essential element in RT and the available agents used may be unique and separate from the patient’s regular course of treatment, primarily because agents used in RT may not be suitable for long-term treatment due to an unfavourable efficacy and safety profile. Therefore, the choice of pharmacotherapy is essential to achieve an effective RT and a smooth transition to standard care and routine daily life for the patient. Of the available agents for RT, aripiprazole demonstrated a favourable efficacy and safety profile both over the short-term – including in its intramuscular form (IM) – and in the long-term treatment of bipolar I disorder and schizophrenia. The objective of this article is to assess the available clinical data on IM aripiprazole as a treatment option for the rapid control of agitation and disturbed behaviours in these conditions and to provide a consensus statement based on the expertise of UK healthcare practitioners in acute treatment units.

P.3.c.028 Intramuscular aripiprazole in mania – clinical experience in the UK

P.3.c.028 Intramuscular aripiprazole in mania – clinical experience in the UK

P.3.d.007 Intramuscular aripiprazole in the management of acute psychomotor agitation: do serum levels correlate with clinical response?

P.3.d.007 Intramuscular aripiprazole in the management of acute psychomotor agitation: do serum levels correlate with clinical response?

A Retrospective Study Exploring the Effects of Intramuscular Aripiprazole on QTc Change in Agitated Medically Ill Patients

A Retrospective Study Exploring the Effects of Intramuscular Aripiprazole on QTc Change in Agitated Medically Ill Patients