Behavioral Activity Rating Scale Research Articles

The safety and efficacy of sequential intramuscular/oral ziprasidone treatment of acute episode in patients with schizophrenia: a multicenter, open-labeled study

BackgroundZiprasidone mesylate injection is an atypical antipsychotic drug which is recently approved in China. In combination with its oral formulation, sequential therapy with ziprasidone brings new interventions to patients with agitation in the acute phase of schizophrenia. The purpose of this 7-day multicenter study conducted in China was to evaluate the efficacy and safety of ziprasidone sequential treatment through intramuscular/oral routes in agitated patients with schizophrenia.MethodsA total of 95 patients were enrolled from three centers in this study. The study duration was 7 days. In the first 3 days, subjects were administered an intramuscular injection of ziprasidone 10–40 mg daily and started sequentially with oral ziprasidone 40–80 mg at dinner (or lunch) from the day of the last intramuscular injection. In the following 4 days, according to the severity of the symptoms and the drug response, 120–160 mg of ziprasidone was orally administered daily. In total, six visits were scheduled to assess the Positive and Negative Syndrome Scale (PANSS), the Behavioral Activity Rating Scale (BARS), the Clinical Global Impression of Severity (CGI-S), and Improvement (CGI-I) scores throughout the procedure. Lastly, adverse events were recorded during treatment.ResultsOut of the 95 patients that were enrolled, 83 cases were effectively completed. Visits 3, 4, 6, PANSS, and PANSS-excited component (PANSS-EC) subscale points, and Visit 2–Visit 6 viewpoints, BARS scale points, and baseline scores denote a progressive downward trend (P < 0.001). In this study, 62 adverse events were reported. The most common adverse events were extrapyramidal symptoms (EPS) (23 cases) and excessive sedation(10 cases), and 13 cases of prolonged QTc interval were reported.ConclusionsZiprasidone IM demonstrated significant and rapid reduction in agitation, and sequential oral formulation keep stability and continuation of the treatment can further ensure efficacy. Ziprasidone sequential therapy may provide a new approach to acute agitation in schizophrenic patients.Trial registrationThe Chinese Clinical Trials Registry; URL: https://www.chictr.org.cn: ChiCTR-OIC-16007970.

Translation, cross-cultural adaptation, and validation of the Behavioral Activity Rating Scale (BARS) for the Brazilian population.

Few instruments are available in Brazil to evaluate psychomotor activity in psychiatric emergency, clinical, and research settings. This study aimed to perform a cross-cultural adaptation of the Behavioral Activity Rating Scale (BARS) into Brazilian Portuguese and assess the adapted scale's psychometric properties. An expert consensus committee conducted a translation and back-translation of the original scale, resulting in the BARS-BR. Four pairs of physicians administered the BARS-BR and the Sedation-Agitation Scale (SAS) to patients in a hospital psychiatry emergency room and patients in the hospital's psychiatric wards. The BARS-BR was compared to the SAS to assess concurrent validity and internal consistency was evaluated with the Bland-Altman technique. In the emergency room, the correlation coefficients between the first and second assessments were rho = 0.997 and rho = 1.0, respectively. In the hospital wards, the correlation coefficient between the pair of evaluators was rho = 0.951. There were strong correlations between the BARS-BR score of the first examiner and the SAS score of the second examiner (rho = 0.903) and between the SAS score of the first examiner and the BARS-BR score of the second examiner (rho = 0.893). The BARS-BR showed good psychometric properties, and we recommend its use because it constitutes an easy method for assessment of changes in psychomotor activity. Further studies are suggested to evaluate adoption and comprehension of the BARS-BR scale by all classes of healthcare professionals.

Use of an Agitation Measure to Screen for Suicide and Self-Harm Risk Among Emergency Department Patients.

Suicidality alone is insensitive to suicide risk among emergency department (ED) patients. We describe the performance of adding an objective assessment of agitation to a suicide screening instrument for predicting suicide and self-harm after an ED encounter. We tested the performance of a novel screener combining the presence of suicidality or agitation for predicting suicide within 90 days or a repeat ED visit for self-harm within 30 days using retrospective data from all patients seen in an urban safety net ED over 27 months. Patients were assessed for suicidality using the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener and for agitation using either the Behavioral Activity Rating Scale or Richmond Agitation Sedation Scale. We hypothesized that a screener based on the presence of either suicidality or agitation would be more sensitive to suicide risk than the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener alone. The screener's performance is described, and multivariable regression evaluates the correlations between screening and outcomes. The sample comprised 16,467 patients seen in the ED who had available suicide screening and agitation data. Thirteen patients (0.08%) died by suicide within 90 days after ED discharge. The sensitivity and specificity of the screener combining suicidality and agitation for predicting suicide was 0.69 (95% confidence interval, 0.44-0.94) and 0.74 (0.44-0.94), respectively. The sensitivity and specificity for agitation combined with positive suicide screening for self-harm within 30 days were 0.95 (0.89-1.00) and 0.73 (0.73-0.74). For both outcomes, augmenting the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener with a measure of agitation improved both sensitivity and overall performance compared to historical performance of the Columbia-Suicide Severity Rating Scale-Clinical Practice Screener alone. Combining a brief objective measure of agitation with a common suicide screening instrument improved sensitivity and predictive performance for suicide and self-harm risk after ED discharge. These findings speak to the importance of assessing agitation not only for imminent safety risk during the patient encounter but also for reducing the likelihood of future adverse events. This work can improve the detection and management of suicide risk in emergency settings.

The agitated pediatric patient located in the emergency department: The APPLIED observational study.

ObjectivesFocused research on pediatric agitation is lacking despite being a common mental and behavioral health (MBH) emergency. Prevalence of pediatric agitation remains unknown, and prior reports may have underestimated the rate of restraint use for pediatric agitation. This is the largest study to provide a focused evaluation of the prevalence and predictors of pediatric agitation and restraint use as well as the emergency department (ED) length of stay (LOS) and admission rates for agitated patients.MethodsWe reviewed records of patients aged ≤18 years with MBH needs who visited the pediatric ED of a tertiary care hospital during a 3‐year‐period. We identified and ascertained agitated/aggressive patients using documented signs/symptoms, International Classification of Diseases, Tenth Revision codes, and Behavioral Activity Rating Scale scores. We performed descriptive and multivariable analyses using SAS 9.4 (SAS Institute).ResultsOf 10,172 patients with MBH needs, 1408 (13.8%) were agitated/aggressive. Of these (n = 1408), 63.7% were boys, and the mean age was 11.9 years. Among agitated patients, the prevalence of restraint use was 28.7%, with a predominance of pharmacologic restraint with atypical antipsychotics. Non‐Hispanic Blacks were more likely to be agitated (adjusted odd ratio [aOR], 1.8; 95% CI, 1.2–2.7), but not restrained (aOR, 0.8; 95% CI, 0.3–1.8). Predictors of restraint use include history of attention deficit hyperactivity disorder (aOR, 2.2; 95% CI, 1.5–3.3), autism (aOR, 2.9; 95% CI, 1.9–4.5), conduct disorder (aOR, 1.7; 95% CI, 1.2–2.5), psychosis (aOR, 14.3; 95% CI, 2.5–271.8), and substance use/overdose states (aOR, 1.9; CI, 1.2–3.2). Restrained agitated patients had longer ED LOS (8.4 vs 5.0 hours; P < 0.0001) and higher admission rates (aOR, 2.6; 95% CI, 2.0–3.5). Depression (aOR, 0.4; 95% CI, 0.3–0.5) and suicidality (aOR, 0.2; 95% CI, 0.1–0.3) were protective against agitation and restraint use.ConclusionPrevalence of acute agitation and restraint use in pediatric EDs may be much higher than previously reported. Predictors of acute agitation and restraint use among MBH patients were consistent with prior reports. Restrained agitated patients had longer ED LOS and higher admission rates.

Commentary on “Care of the Behavioral Health Patient in the Emergency Department”

In this issue of the Journal of Emergency Nursing, there are 3 excellent articles that discuss various aspects of caring for patients with behavioral health–related presentations in the emergency setting. 1 True G Pollock M Bowden CF et al. Strategies to care for patients being treated in the emergency department after self-harm: perspectives of frontline staff. J Emerg Nurs. 2021; 47: 426-436https://doi.org/10.1016/j.jen.2020.12.016 Abstract Full Text Full Text PDF Scopus (4) Google Scholar , 2 Valdes B Salani D King B De Oliviera GC Recognition and treatment of pychiatric emergencies for health care providers in the emergency department: panic attack, panic disorder, and adverse drug reaction. J Emerg Nurs. 2021; 47: 459-468https://doi.org/10.1016/j.jen.2021.01.004 Abstract Full Text Full Text PDF Scopus (2) Google Scholar , 3 Legambi TF Doede M Michael K Zaleski M A quality improvement project on agitation management in the emergency department. J Emerg Nurs. 2021; 47: 390-399https://doi.org/10.1016/j.jen.2021.01.005 Abstract Full Text Full Text PDF Scopus (1) Google Scholar Although a very large number of diagnoses are subsumed under the broad heading “behavioral health,” the specific illnesses and their manifestations are quite distinct. The aforementioned 3 articles demonstrate these distinctions well. Patients being treated after self-harm need to be assessed and treated quite differently from patients experiencing a panic attack, and both differ markedly from the assessment and management of the patient who is agitated and has the potential for violence. However, the essentials of care that patients with behavioral health–related presentations need and deserve from emergency caregivers are similar in many ways. Anne Manton is former Editor-in-Chief, retired, of Journal of Emergency Nursing. A Quality Improvement Project on Agitation Management in the Emergency DepartmentJournal of Emergency NursingVol. 47Issue 3PreviewAgitation is common in the emergency department. When agitation is not detected early, patients can become aggressive and violent, potentially leading to restraint use and subsequent injury. The goals of the project were early detection and management of patient agitation, reduction of restraint use in the emergency department, and determination of the usability of the Behavioral Activity Rating Scale. Full-Text PDF Recognition and Treatment of Psychiatric Emergencies for Health Care Providers in the Emergency Department: Panic Attack, Panic Disorder, and Adverse Drug ReactionsJournal of Emergency NursingVol. 47Issue 3PreviewMental health disorders are common in the United States and may cause significant disturbances in all aspects of a person’s life. Individuals with mental health disorders often present to emergency departments for health care. Recognizing and managing common psychiatric emergencies may be challenging for non–mental health providers. The Diagnostic Statistical Manual-5 diagnostic criteria will be discussed and reviewed for panic attack and panic disorder. Both pharmacologic and nonpharmacologic treatment strategies will also be addressed. Full-Text PDF Strategies to Care for Patients Being Treated in the Emergency Department After Self-harm: Perspectives of Frontline StaffJournal of Emergency NursingVol. 47Issue 3PreviewEvery year, approximately 500 000 patients in the United States present to emergency departments for treatment after an episode of self-harm. Evidence-based practices such as designing safer ED environments, safety planning, and discharge planning are effective for improving the care of these patients but are not always implemented with fidelity because of resource constraints. The aim of this study was to provide insight into how ED staff innovate processes of care and services by leveraging what is available on-site or in their communities. Full-Text PDF

A Quality Improvement Project on Agitation Management in the Emergency Department

IntroductionAgitation is common in the emergency department. When agitation is not detected early, patients can become aggressive and violent, potentially leading to restraint use and subsequent injury. The goals of the project were early detection and management of patient agitation, reduction of restraint use in the emergency department, and determination of the usability of the Behavioral Activity Rating Scale. MethodsThis quality improvement project was assessed using a pre- and posttest single unit design, comparing 4 months of postimplementation data to historic controls at the same time of year in the previous year. The intervention was implementing the Behavioral Activity Rating Scale in the ED electronic medical record. Data were collected through retrospective chart review and nurse survey. From September through December of both 2017 and 2018, data were collected on restraint use. The 4-month 2018 data collection period included measures of Behavioral Activity Rating Scale documentation and the System Usability Scale survey for nurses to measure ease of usability of the Behavioral Activity Rating Scale. ResultsThe Behavioral Activity Rating Scale was documented frequently (n = 4 867 documentations) by emergency nurses to assess patients with behavioral health and medical complaints (n = 780). Nurses identified 18 episodes of violent behavior in behavioral health patients on the Behavioral Activity Rating Scale (2.31%) and applied restraints 18 times. The most common chief complaints for patients who were identified as violent was suicidal ideation (n = 6; 33.33%).In 2017, there were 20 episodes of restraint use during the same time period, a nonsignificant difference (χ2 = 0.72; P = 0.40). However, only 2 patients were kept in restraints longer than 1 day in 2018 compared with 8 in 2017. Emergency nurses found the Behavioral Activity Rating Scale to be usable in the structured usability assessment (μ = 83.46; SD = 11.73). DiscussionThe Behavioral Activity Rating Scale is a usable tool for emergency nurses to assess for patient agitation. With the incorporation of agitation management interventions, the ED team can potentially manage agitation before violence occurs. Further studies are needed on the use of agitation or aggression assessment tools for managing patient behavioral activity such as aggression in the emergency department.

Use of Intramuscular Chlorpromazine Versus Intramuscular Olanzapine for the Management of Acute Agitation and Aggression in Youth.

In the inpatient psychiatric setting, one treatment strategy used to manage acute agitation in youth includes administration of IM antipsychotics. The aim of this study was to compare the effectiveness and safety of IM chlorpromazine versus IM olanzapine in treating aggression in youth. We conducted a retrospective chart review of patients younger than 18 years hospitalized in the inpatient psychiatric unit who received either IM chlorpromazine or IM olanzapine for acute agitation. Demographic, efficacy, and tolerability data were collected using the electronic health record EPIC. The primary outcome was change from baseline to end point in the Behavioral Activity Rating Scale (BARS) score. BARS was applied retrospectively using nursing and physician documentation to evaluate for clinical response. Among 145 patients who met the inclusion criteria, 72 received IM chlorpromazine, compared with 73 who received IM olanzapine. The mean change in BARS score (before and after IM antipsychotic) was greater with olanzapine (3.58 ± 0.99) than with chlorpromazine (3.07 ± 1.18, p = 0.006). The target BARS score of 4 was achieved more frequently with chlorpromazine (45.8%) than with olanzapine (24.7%, p < 0.008). Coadministration of IM diphenhydramine occurred significantly more often in the olanzapine group than in the chlorpromazine group (71.2% vs 36.1%, p < 0.001). Management of acute agitation with IM olanzapine resulted in a greater change in BARS score, despite more youth requiring coadministration with diphenhydramine. In comparison, IM chlorpromazine demonstrated a higher likelihood of returning patients to baseline. Study results suggest tolerability of IM chlorpromazine and olanzapine.

Prevalence and risk factors of agitation in newly hospitalized schizophrenia patients in China: An observational survey

This multi-center observational study investigated the prevalence of agitation in newly hospitalized schizophrenia patients in China and its potential risk factors. It was performed in 2014 and covered 14 hospitals. Newly hospitalized patients with schizophrenia or suspected schizophrenia who met the diagnostic criteria of the International Statistical Classification of Diseases and Related Health Problems, 10th revision, were recruited. Agitation and related risk factors were evaluated by a questionnaire designed for the survey. General demographic data, disease characteristics, scores on schizophrenia rating scales and agitation rating scales (e.g., Positive and Negative Syndrome Scale-Excited Component [PANSS-EC] and Behavioral Activity Rating Scale [BARS]) were collected. Among the 1512 patients screened in the study, 1400 (92.59%) were eligible. According to the PANSS-EC and BARS, the prevalence of agitation was 60.92% (853 of 1400) and 59.00% (826 of 1400), respectively. The overall prevalence of agitation was 47.50% (665 of 1400). The most important risk factor of agitation was being aggressive at baseline (Modified Overt Aggression Scale score ≥4, odds ratio=6.54; 95% confidence interval=4.93–8.69). Other risk factors included a history of aggressive behavior, northern region of residence, involuntary hospitalization, disease severity, low level of education, living alone, being unemployed or retired.

Efficacy and Safety of Loxapine for Inhalation in the Treatment of Agitation in Patients With Schizophrenia

The objective of this study was to assess the efficacy and safety of inhaled loxapine in the treatment of agitation in patients with psychotic disorders. In this randomized, double-blind, placebo-controlled study, 129 agitated patients with schizophrenia or schizoaffective disorder (DSM-IV criteria) were randomized to receive in a clinical or hospital setting a single inhalation of 5 or 10 mg of loxapine or placebo administered using the Staccato loxapine for inhalation device. The inhalation device delivered thermally generated drug aerosol to the deep lung for rapid absorption. The primary efficacy measure was change on the Positive and Negative Syndrome Scale-excited component (PANSS-EC) 2 hours following treatment. Secondary outcomes included the Clinical Global Impressions-Improvement scale (CGI-I), Behavioral Activity Rating Scale (BARS), and time to first rescue medication. The study was conducted between September 2006 and January 2007. Differences were statistically significant (P < .05) between placebo and both 5-mg and 10-mg doses on the CGI-I and the CGI-I responder analyses at 2 hours and in time to first rescue medication, and they were statistically significant (P < .05) between placebo and 10-mg loxapine on the PANSS-EC 20 minutes after administration continuing through 2 hours and in change from baseline BARS. Three serious adverse events occurred at least 6 days after treatment, but none were judged related to study treatment. The most common adverse events were sedation and dysgeusia (22% and 17%, respectively, in the 10-mg group, and 14% and 9%, respectively, in the placebo group). Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted. ClinicalTrials.gov identifier: NCT00369577.

Using a Single-item Rating Scale as a Psychiatric Behavioral Management Triage Tool in the Emergency Department

Proper monitoring of patients' behavior is essential for effective treatment and efficient disposition of psychiatric cases in the adult emergency department. The goal of the current study was to examine an attempt to implement the Behavioral Activity Rating Scale, an existing single-item measure of behavioral activity, as part of a behavioral management triage strategy for psychiatric patients in an emergency department. For the period beginning approximately 2 months after use of the behavioral activity measure was initiated in the emergency department, charts from 284 consecutive patients who presented to the department with a chief complaint that was psychiatric in nature were reviewed. Level of adoption of the measure by emergency nurses was lower than desired; only 46% of charts reviewed contained a behavioral activity rating. Ratings were less likely to be recorded during the night shift than during other shifts. As predicted, ratings indicative of elevated behavioral activity were associated with physician orders for formal behavioral management (ie, intramuscular, intravenous, or orally dissolving sedating medications or physical restraint). The findings of this study suggest that a single-item behavioral activity measure may be an efficient, effective, and discreet way for emergency nursing staff to communicate with one another and with physicians about psychiatric patients in need of behavioral management in adult emergency departments. The findings also suggest that a broad implementation approach is needed to achieve desired levels of adoption by emergency nursing staff.

P03-364 Comparison of intramuscular ziprasidone and haloperidol for acute psychotic agitation in an emergency room

ObjectivesTo compare the efficacy and safety of the intramuscular formulations of ziprasidone and haloperidol in treating agitation in schizophrenic patients attended in an emergency room.MethodConsecutive patients were alternatively assigned to receive 20 mg of IM ziprasidone or 10 mg of IM haloperidol. Efficacy measures were improvement in Behavioral Activity Rating Scale (BARS), in the sum of five items of the Positive and Negative Syndrome Scale that focused on agitation (PANSS-A) and scores on the Clinical Global Impression improvement scale (CGI-I), obtained 45 minutes and 2 hours after the IM medication. Tolerability assessments included changes in ECG, monitoring of vital signs and register of adverse events.ResultsFinally 18 patients (13 men, mean age 40.8 ±10.2) were included in the analysis of data. At arrival in the emergency room, there were no differences between ziprasidone (Z) and haloperidol (H) groups in age, mean QTc length, mean BARS and mean PANSS-A scores. Analyzing the global sample there was an improvement in agitation scores. No significant differences were found between the groups in change of BARS and PANSS-A scores, in CGI-I scores or in the variation of the length of QTc interval at two hours. No serious adverse events were reported.ConclusionsIn spite of the small sample size, both treatments ziprasidone IM and haloperidol IM seems to be similarly effective for the management of psychotic agitation in the emergency room. Both were well tolerated. Lengthening of QTc interval due to ziprasidone IM had not been found in our sample.

Suicide Risk Assessment: 6 Steps to a Better Instrument

Recent research indicates that commonly used instruments to assess suicidal ideation identify patients at chronic risk for suicide but do not identify those who are at acute (imminent) risk for suicide while hospitalized. Items to measure anxiety and agitation, identified as more appropriate risk factors, should be incorporated into suicide risk assessments. The purpose of this article was to develop an evidence-based imminent suicide risk instrument for an inpatient psychiatric unit. The Iowa Model of Evidence-Based Practice to Promote Quality Care guided development. Two validated instruments, the Hamilton Anxiety Scale (to measure anxiety) and the Behavioral Activity Rating Scale (to measure agitation) were applied to 75 patients to help create an evidence-based instrument, which should more accurately identify hospitalized patients at risk for imminent suicide.

A Retrospective Chart Review of Intramuscular Ziprasidone for Agitation in Children and Adolescents on Psychiatric Units: Prospective Studies Are Needed

Our primary objective was to evaluate the effectiveness and tolerability of intramuscular ziprasidone for impulsivity and agitation in psychiatrically hospitalized children and adolescents. Our secondary objective was to examine demographic and clinical factors associated with treatment response. We conducted a retrospective chart review of children and adolescents admitted to Cincinnati Children's Hospital Medical Center (CCHMC) psychiatric units between January 1, 2002, and July 11, 2005, who received intramuscular ziprasidone. Medical records were reviewed to determine demographic and clinical information as well as tolerability and effectiveness of ziprasidone. The Behavioral Activity Rating Scale (BARS) was used retrospectively to assess clinical response. Regression analyses were performed to evaluate the effect of demographic factors (age, gender, and ethnicity) and primary psychiatric diagnoses on treatment response. Electrocardiogram (ECG) data was inadequate. Fifty nine children and adolescents received a total of 77 injections of intramuscular ziprasidone for acute agitation. The mean +/- SD BARS score decreased from 6.5 +/- 0.7 to 3.1 +/- 1.3. The most common side effect was drowsiness or falling asleep (n = 46, 60%). Three (4%) could not be roused after the injection. Intramuscular ziprasidone may be helpful for agitation but often caused oversedation. Safety data, including ECGs, is needed in controlled prospective studies.

Response- and remission rates as efficacymarker of monotherapy with atypical neuroleptics in the treatment of acute mania

Atypical antipsychotics have gained acceptance as first-line treatment for psychotic disorders. Rapid-acting intramuscular (IM) atypicals may supplant benzodiazepine and/or neuroleptic alternatives. IM atypical ziprasidone studies excluded severe psychiatric agitation (PSYCH), or that due to the abuse of alcohol (ETOH) or other substances (SUBS). We report Behavioral Activity Rating Scale agitation scores (range, 1–7) and duration of physical restraints in a naturalistic study in a psychiatric emergency service using IM ziprasidone 20 mg and various doses for conventional antipsychotics. Baseline scores were high for PSYCH, ETOH and SUBS patients (mean, 6.5, 6.9 and 6.6, respectively). Agitation decreased rapidly from baseline with ziprasidone [mean, 5.6, 5.3 and 5.8, respectively, at 15 min (P<.05 for all), and 4.2, 4.1 and 4.1, respectively, at 30 min (P<.01 for all)]. At 2 h, scores were 2.6, 2.1 and 2.3 (P<.01 for all versus baseline). For 9 patients receiving conventional IM antipsychotics, scores were 6.6 (baseline), 5.7 (15 min), 4.2 (30 min) and 2.9 (2 h) (P<.02 versus ziprasidone). Compared with restraint durations from 80 patients receiving conventional IM agents 1 month prior to this study, restraint duration decreased from 91±4 to 54±3 min with ziprasidone (n=77; P<.01) and varied with conventional IM agents (mean, 60±12 min; n=4; P=NS). None of the 19 ziprasidone patients who received electrocardiograms showed prolonged QTc; one had a dystonic reaction. IM ziprasidone appears effective for severe agitation, including agitation associated with alcohol or substance intoxication, and may reduce time in restraints.

A Pilot, Open-Label Safety Study of Quetiapine for Treatment of Moderate Psychotic Agitation in the Emergency Setting

The goal of this pilot study was primarily to explore the safety and, secondarily, the efficacy of the use of "prn" quetiapine for treatment of moderate agitation accompanied by psychosis in an emergency department setting. This was an open-label study in which 20 patients with psychotic agitation were treated in the emergency department with 100, 150, or 200 mg of quetiapine. Physicians who were unaffiliated with the study established the diagnoses and selected the doses to be used for each patient. A rater who was blinded to the dose performed the assessments. The primary safety measure was the onset of orthostatic hypotension. The primary efficacy measure was a 40% reduction in scores on the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) over 120 minutes. The secondary efficacy measure was a reduction of 2 points or more on the Behavioral Activity Rating Scale (BARS) at 120 minutes post-dose. All subjects provided written informed consent. With regard to safety outcomes, 40% of subjects exhibited orthostasis by 120 minutes, although only 25% of these patients described clinically significant symptoms. In terms of efficacy, 50% of subjects experienced at least a 40% reduction in PANSS-EC scores at 2 hours, while 68.8% showed reductions of 2 points or more in scores on the BARS over the same time period. Quetiapine demonstrated some efficacy as a sedative agent in the emergency setting, although no clear dose-response pattern emerged over the narrow dose range tested. Orthostasis was common and did not correlate with dosing. This small study did not support the use of quetiapine to treat acute agitation in potentially volume-depleted patients.

Intramuscular Ziprasidone Treatment of Acute Psychotic Agitation in Elderly Patients With Schizophrenia

Intramuscular (i.m.) ziprasidone treatment has been shown to be effective and well tolerated in reducing the symptoms of acute psychosis in adults. Few data are available as to safety in the elderly. The growing utilization of health services by elderly psychiatric patients warrants an evaluation in this population. Consecutive elderly patients (60 years of and older) admitted to a psychogeriatric ward in a large, university-affiliated tertiary psychiatric center were treated by i.m. ziprasidone for acute psychotic agitation. Patients received three days of flexible-dose i.m. ziprasidone. After an initial dose of 10-20 mg, a subsequent dose of 10-20 mg could be given after 12 hours if needed (maximum daily dose: 40 mg). All treatment emergent side effects and adverse events along with the investigators' assessments of severity were systematically recorded as the primary outcome. The Brief Psychiatric Rating Scale (BPRS) and the Behavioral Activity Rating Scale (BARS) were the secondary outcomes. Twenty-one patients, six male and 15 female, mean age 71.4 +/- 1.3 years (range: 60-81 years) were enrolled. All had completed the three days i.m. ziprasidone treatment. There was one adverse event in a patient with untreated benign prostatic hypertrophy who developed urinary retention. Two side effects of mild severity that resolved spontaneously were observed: blurred vision and sedation. The BPRS decreased by 26.8 points after three days of treatment (p = 0.001). The BARS score, reflecting agitation, decreased significantly after each injection, reaching maximal decrease of 2.14 points at completion of study (p = 0.001). Intramuscular ziprasidone in this series of elderly patients suggests acceptable safety and efficacy in the management of acute psychotic agitation among elderly patients with schizophrenia.

Rapid-acting IM ziprasidone in a psychiatric emergency service: a naturalistic study

Atypical antipsychotics have gained acceptance as first-line treatment for psychotic disorders. Rapid-acting intramuscular (IM) atypicals may supplant benzodiazepine and/or neuroleptic alternatives. IM atypical ziprasidone studies excluded severe psychiatric agitation (PSYCH), or that due to the abuse of alcohol (ETOH) or other substances (SUBS). We report Behavioral Activity Rating Scale agitation scores (range, 1–7) and duration of physical restraints in a naturalistic study in a psychiatric emergency service using IM ziprasidone 20 mg and various doses for conventional antipsychotics. Baseline scores were high for PSYCH, ETOH and SUBS patients (mean, 6.5, 6.9 and 6.6, respectively). Agitation decreased rapidly from baseline with ziprasidone [mean, 5.6, 5.3 and 5.8, respectively, at 15 min ( P<.05 for all), and 4.2, 4.1 and 4.1, respectively, at 30 min ( P<.01 for all)]. At 2 h, scores were 2.6, 2.1 and 2.3 ( P<.01 for all versus baseline). For 9 patients receiving conventional IM antipsychotics, scores were 6.6 (baseline), 5.7 (15 min), 4.2 (30 min) and 2.9 (2 h) ( P<.02 versus ziprasidone). Compared with restraint durations from 80 patients receiving conventional IM agents 1 month prior to this study, restraint duration decreased from 91±4 to 54±3 min with ziprasidone ( n=77; P<.01) and varied with conventional IM agents (mean, 60±12 min; n=4; P=NS). None of the 19 ziprasidone patients who received electrocardiograms showed prolonged QTc; one had a dystonic reaction. IM ziprasidone appears effective for severe agitation, including agitation associated with alcohol or substance intoxication, and may reduce time in restraints.

Intramuscular ziprasidone in agitated patients with bipolar diagnoses

Study objectives: We evaluate the efficacy of intramuscular ziprasidone in agitated patients with bipolar disorder or schizoaffective disorder bipolar type. Methods: This was a subgroup analysis of 2 similarly designed, randomized, double-blind, fixed-dose, 24-hour studies of intramuscular ziprasidone in agitated patients with bipolar disorder or schizoaffective disorder bipolar type. Patients received 2-mg control dose (n=15) versus 10 mg (n=20) and 2-mg control dose (n=11) versus 20 mg (n=15; 80 mg maximum). Efficacy was assessed by Behavioral Activity Rating Scale (BARS), Clinical Global Impression Scale of Severity (CGI–S), and Positive and Negative Syndrome Scale Agitation items scores. Results: The greatest reductions in agitation (mean change in BARS) at 2 hours and 4 hours after the first dose were seen with 20-mg intramuscular ziprasidone. At 4 hours, the greatest improvement in CGI–S was seen in the 20-mg ziprasidone group. Responder rates (≥2-point decrease in BARS at 1.5 hours after first dose) were 80% in the 20-mg group (P≤.01 versus 2-mg control) and 58% in the 10-mg group, similar to results in the primary studies. No dystonia or excessive sedation was reported in either dosage group; 1 patient in the 10-mg group experienced akathisia. Conclusion: Ziprasidone at 10 and 20 mg intramuscularly was rapidly effective and well tolerated in agitated psychotic patients with bipolar spectrum diagnoses, with the 20-mg intramuscular dose producing the largest decrease in agitation. The 10-mg dosage level is not consistently effective. Study objectives: We evaluate the efficacy of intramuscular ziprasidone in agitated patients with bipolar disorder or schizoaffective disorder bipolar type. Methods: This was a subgroup analysis of 2 similarly designed, randomized, double-blind, fixed-dose, 24-hour studies of intramuscular ziprasidone in agitated patients with bipolar disorder or schizoaffective disorder bipolar type. Patients received 2-mg control dose (n=15) versus 10 mg (n=20) and 2-mg control dose (n=11) versus 20 mg (n=15; 80 mg maximum). Efficacy was assessed by Behavioral Activity Rating Scale (BARS), Clinical Global Impression Scale of Severity (CGI–S), and Positive and Negative Syndrome Scale Agitation items scores. Results: The greatest reductions in agitation (mean change in BARS) at 2 hours and 4 hours after the first dose were seen with 20-mg intramuscular ziprasidone. At 4 hours, the greatest improvement in CGI–S was seen in the 20-mg ziprasidone group. Responder rates (≥2-point decrease in BARS at 1.5 hours after first dose) were 80% in the 20-mg group (P≤.01 versus 2-mg control) and 58% in the 10-mg group, similar to results in the primary studies. No dystonia or excessive sedation was reported in either dosage group; 1 patient in the 10-mg group experienced akathisia. Conclusion: Ziprasidone at 10 and 20 mg intramuscularly was rapidly effective and well tolerated in agitated psychotic patients with bipolar spectrum diagnoses, with the 20-mg intramuscular dose producing the largest decrease in agitation. The 10-mg dosage level is not consistently effective.

Intramuscular ziprasidone in the psychiatric emergency department: expanded sample

Study objectives: Injectable atypical neuroleptics may supplant benzodiazepine or neuroleptic alternatives. Published studies of intramuscular ziprasidone excluded severe psychiatric agitation (AGIT) and agitation from alcohol (ETOH) or other substances (SUBS). This study sought to assess the efficacy of intramuscular ziprasidone in these patients. Methods: We report additional data on Behavioral Activity Rating Scale (BARS) agitation scores (minimum=1, maximum=7) and duration of physical restraints in a naturalistic psychiatric emergency department study with agitated patients. Dosages were 20 mg for intramuscular ziprasidone and varied for conventional intramuscular antipsychotics (78% haloperidol or lorazepam). Results: Baseline scores on the BARS were high for AGIT (n=72), ETOH (n=10), and SUBS (n=28; respective means: 6.5, 6.9, 6.6; P =NS for all). Ziprasidone decreased agitation rapidly (respective means: 5.6, 5.3, and 5.8 at 15 minutes [ P P P P P =NS). Of 19 ziprasidone patients receiving ECGs, none had prolonged QTc interval; 1 dystonic reaction occurred with ziprasidone. Conclusion: Intramuscular ziprasidone appears effective for severe agitation, including that from alcohol- or substance-induced intoxication. Intramuscular ziprasidone may also lead to reduced time in restraints compared with conventional agents.

Visualising cognitive enhancement in schizophrenia

Atypical antipsychotics have gained acceptance as first-line treatment for psychotic disorders. Rapid-acting intramuscular (IM) atypicals may supplant benzodiazepine and/or neuroleptic alternatives. IM atypical ziprasidone studies excluded severe psychiatric agitation (PSYCH), or that due to the abuse of alcohol (ETOH) or other substances (SUBS). We report Behavioral Activity Rating Scale agitation scores (range, 1–7) and duration of physical restraints in a naturalistic study in a psychiatric emergency service using IM ziprasidone 20 mg and various doses for conventional antipsychotics. Baseline scores were high for PSYCH, ETOH and SUBS patients (mean, 6.5, 6.9 and 6.6, respectively). Agitation decreased rapidly from baseline with ziprasidone [mean, 5.6, 5.3 and 5.8, respectively, at 15 min (P<.05 for all), and 4.2, 4.1 and 4.1, respectively, at 30 min (P<.01 for all)]. At 2 h, scores were 2.6, 2.1 and 2.3 (P<.01 for all versus baseline). For 9 patients receiving conventional IM antipsychotics, scores were 6.6 (baseline), 5.7 (15 min), 4.2 (30 min) and 2.9 (2 h) (P<.02 versus ziprasidone). Compared with restraint durations from 80 patients receiving conventional IM agents 1 month prior to this study, restraint duration decreased from 91±4 to 54±3 min with ziprasidone (n=77; P<.01) and varied with conventional IM agents (mean, 60±12 min; n=4; P=NS). None of the 19 ziprasidone patients who received electrocardiograms showed prolonged QTc; one had a dystonic reaction. IM ziprasidone appears effective for severe agitation, including agitation associated with alcohol or substance intoxication, and may reduce time in restraints.