Ranking important predictors of the need for a high-acuity psychiatry unit among 2,064 inpatients admitted to psychiatric emergency hospitals: a random forest model.

Aims: In order to uphold and enhance the emergency psychiatric care system, a thorough comprehension of the characteristics of patients who require a high-acuity psychiatry unit is indispensable. We aimed to clarify the most important predictors of the need for a high-acuity psychiatry unit using a random forest model. Methods: This cross-sectional study encompassed patients admitted to psychiatric emergency hospitals at 161 medical institutions across Japan between December 8, 2022, and January 31, 2023. Questionnaires were completed by psychiatrists, with a maximum of 30 patients assessed per medical institution. The questionnaires included psychiatrists' assessment of the patient's condition (exposure variables) and the need for a high-acuity psychiatry unit (outcome variables). The exposure variables consisted of 32 binary variables, including age, diagnoses, and clinical condition (i.e., factors on the clinical profile, emergency treatment requirements, and purpose of hospitalization). The outcome variable was the need for a high-acuity psychiatry unit, scored from 0 to 10. To identify the most important predictors of the need for a high-acuity psychiatry unit, we used a random forest model. As a sensitivity analysis, multivariate linear regression analysis was performed. Results: Data on 2,164 patients from 81 medical institutions were obtained (response rate, 50.3%). After excluding participants with missing values, this analysis included 2,064 patients. Of the 32 items, the top-5 predictors of the need for a high-acuity psychiatry unit were the essentiality of inpatient treatment (otherwise, symptoms will worsen or linger), need for 24-hour professional care, symptom severity, safety ensured by specialized equipment, and medication management. These items were each significantly and positively associated with the need for a high-acuity psychiatry unit in linear regression analyses (p < 0.001 for all). Conversely, items on age and diagnosis were lower in the ranking and were not statistically significant in linear regression models. Conclusion: Items related to the patient's clinical profile might hold greater importance in predicting the need for a high-acuity psychiatry unit than do items associated with age and diagnosis.

Live two-way video versus face-to-face treatment for depression, anxiety, and obsessive-compulsive disorder: A 24-week randomized controlled trial.

AIM: Live two-way video, easily accessible from home via smartphones and other devices, is becoming a new way of providing psychiatric treatment. However, lack of evidence for real-world clinical setting effectiveness hampers its approval by medical insurance in some countries. Here, we conducted the first large-scale pragmatic, randomized controlled trial to determine the effectiveness of long-term treatment for multiple psychiatric disorders via two-way video using smartphones and other devices, which are currently the primary means of telecommunication. METHODS: This randomized controlled trial compared two-way video versus face-to-face treatment for depressive disorder, anxiety disorder, and obsessive-compulsive disorder in the subacute/maintenance phase during a 24-week period. Adult patients with the above-mentioned disorders were allocated to either a two-way video group (≥50% video sessions) or a face-to-face group (100% in-person sessions) and received standard treatment covered by public medical insurance. The primary outcome was the 36-Item Short-Form Health Survey Mental Component Summary (SF-36 MCS) score. Secondary outcomes included all-cause discontinuation, working alliance, adverse events, and the severity rating scales for each disorder. RESULTS: A total of 199 patients participated in this study. After 24 weeks of treatment, two-way video treatment was found to be noninferior to face-to-face treatment regarding SF-36 MCS score (48.50 vs 46.68, respectively; p < 0.001). There were no significant differences between the groups regarding most secondary end points, including all-cause discontinuation, treatment efficacy, and satisfaction. CONCLUSION: Two-way video treatment using smartphones and other devices, was noninferior to face-to-face treatment in real-world clinical settings. Modern telemedicine, easily accessible from home, can be used as a form of health care.

Real-world effectiveness of antipsychotic treatments in 1011 acutely hospitalized patients with schizophrenia: A one-year follow-up study.

PURPOSE: To compare the real-world effectiveness of antipsychotic treatments focusing on long-acting injectable antipsychotic medications (LAIs) and antipsychotic polytherapies except polytherapy involving clozapine (APEC) for patients with schizophrenia. METHODS: This prospective study was conducted over a 19-month period in 12 psychiatric emergency hospitals in Japan. Patients who were newly admitted to psychiatric emergency wards between September 2019 and March 2020 because of acute onset or exacerbation of Schizophrenia and Other Psychotic Disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, were included. All patients were followed for one-year after discharge or until March 31, 2021. The primary outcome was the risk of treatment failure defined as psychiatric rehospitalization, discontinuation of medication, death, or continuation of hospitalization for one year. Cox proportional hazards multivariate regression was used for analyses. RESULTS: A total of 1011 patients were enrolled (women, 53.7%; mean [SD] age, 47.5 [14.8] years). During follow-up, 588 patients (58.2%) experienced treatment failure including rehospitalization (513 patients), discontinuation of medication (17 patients), death (11 patients), and continuation of hospitalization for one-year (47 patients). Switching to LAIs (hazard ratio [HR] 0.810, 95%CI 0.659-0.996) and APEC (HR 0.829, 95%CI 0.695-0.990) were significantly associated with a low rate of treatment failure. CONCLUSIONS: Switching to LAIs and APEC in early non-responders seems to be beneficial for the prevention of treatment failure in acutely admitted patients with schizophrenia. The risk of treatment failure was about 19% and 17% lower in patients treated with LAIs and APEC, respectively, than in patients treated without them.

Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology.

INTRODUCTION: The COVID-19 pandemic has had a profound impact on the mental health of people around the world. Anxiety related to infection, stress and stigma caused by the forced changes in daily life have reportedly increased the incidence and symptoms of depression, anxiety disorder and obsessive-compulsive disorder. Under such circumstances, telepsychiatry is gaining importance and attracting a great deal of attention. However, few large pragmatic clinical trials on the use of telepsychiatry targeting multiple psychiatric disorders have been conducted to date. METHODS: The targeted study cohort will consist of adults (>18 years) who meet the DSM-5 diagnostic criteria for either (1) depressive disorders, (2) anxiety disorders, or (3) obsessive-compulsive and related disorders. Patients will be assigned in a 1:1 ratio to either a "telepsychiatry group" (at least 50% of treatments to be conducted using telemedicine, with at least one face-to-face treatment [FTF] within six months) or an "FTF group" (all treatments to be conducted FTF, with no telemedicine). Both groups will receive the usual treatment covered by public medical insurance. The study will utilize a master protocol design in that there will be primary and secondary outcomes for the entire group regardless of diagnosis, as well as the outcomes for each individual disorder group. DISCUSSION: This study will be a non-inferiority trial to test that the treatment effect of telepsychiatry is not inferior to that of FTF alone. This study will provide useful insights into the effect of the COVID-19 pandemic on the practice of psychiatry. TRIAL REGISTRATION: jRCT1030210037, Japan Registry of Clinical Trials (jRCT).

Low-GDP, pH-neutral solutions preserve peritoneal endothelial glycocalyx during long-term peritoneal dialysis.

BACKGROUND: During peritoneal dialysis (PD), solute transport and ultrafiltration are mainly achieved by the peritoneal blood vasculature. Glycocalyx lies on the surface of endothelial cells and plays a role in vascular permeability. Low-glucose degradation product (GDP), pH-neutral PD solutions reportedly offer higher biocompatibility and lead to less peritoneal injury. However, the effects on the vasculature have not been clarified. METHODS: Peritoneal tissues from 11 patients treated with conventional acidic solutions (acidic group) and 11 patients treated with low-GDP, pH-neutral solutions (neutral group) were examined. Control tissues were acquired from 5 healthy donors of kidney transplants (control group). CD31 and ratio of luminal diameter to vessel diameter (L/V ratio) were evaluated to identify endothelial cells and vasculopathy, respectively. Immunostaining for heparan sulfate (HS) domains and Ulex europaeus agglutinin-1 (UEA-1) binding was performed to assess sulfated glycosaminoglycans and the fucose-containing sugar chain of glycocalyx. RESULTS: Compared with the acidic group, the neutral group showed higher CD31 positivity. L/V ratio was significantly higher in the neutral group, suggesting less progression of vasculopathy. Both HS expression and UEA-1 binding were higher in the neutral group, whereas HS expression was markedly more preserved than UEA-1 binding in the acidic group. In vessels with low L/V ratio, which were found only in the acidic group, HS expression and UEA-1 binding were diminished, suggesting a loss of glycocalyx. CONCLUSION: Peritoneal endothelial glycocalyx was more preserved in patients treated with low-GDP, pH-neutral solution. The use of low-GDP, pH-neutral solutions could help to protect peritoneal vascular structures and functions.

Real-world effectiveness of antipsychotic monotherapy and polytherapy in 1543 patients with acute-phase schizophrenia.

PURPOSE: The effectiveness of antipsychotic treatments in the acute phase of schizophrenia in actual clinical practice remains somewhat unclear. Therefore, the purpose of the present naturalistic, multi-center study conducted from 1 year starting in September 2017 was to examine the response rate to an initial or second antipsychotic in newly admitted patients with acute-phase schizophrenia, as well as the response rate and quality of augmentation with two antipsychotics in patients who failed to respond to both the initial and second antipsychotics. RESULTS: In total, there were 660 (42.8%) and 243 (15.7%) responders to an initial and a second antipsychotic, respectively; thus, 58.5% of all patients were responders to an initial or second antipsychotic. Among 581 nonresponders (37.7%), the initial antipsychotic or a third antipsychotic was added to the second antipsychotic. Among these patients, 89.8% showed a Clinical Global Impression-Improvement score ≤3 (from 'minimally improved' to 'very much improved'). The rates of adverse events such as hyperglycemia, hyper-low-density lipoprotein cholesterolemia, hypertriglyceridemia, hyperprolactinemia, QTc prolongation, and extrapyramidal symptoms were not high in patients receiving augmentation with two antipsychotics compared with all patients, and no serious adverse events were reported. CONCLUSION: Antipsychotic augmentation may be an option in acute-phase treatment for patients who do not respond to either an initial or a second antipsychotic.

Psychiatric Admissions and Length of Stay During Fiscal Years 2014 and 2015 in Japan: A Retrospective Cohort Study Using a Nationwide Claims Database.

BACKGROUND: A better understanding of resource use of new psychiatric admissions is important for healthcare providers and policymakers to improve psychiatric care. This study aims to describe the pattern of new psychiatric admissions and length of stay in Japan. METHODS: A retrospective cohort study was conducted using data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). All patients newly admitted to psychiatric wards from April 2014 through March 2016 were included and followed up until discharge to the community. RESULTS: Our sample included 605,982 admissions from 1,621 hospitals over 2 years. The average monthly number of admissions was 25,024 in fiscal year 2014 and 25,475 in fiscal year 2015. There was a seasonal trend in the number of admissions, with a peak in summer (in July). The discharge rates within 90 days and 360 days were 64.1% and 85.7%, respectively, and varied by type of hospital fee and by hospital. For example, the range of hospital-level discharge rate within 90 days in psychiatric emergency units was 46.0-75.3% in the 1st (lowest) quintile, while it was 83.6-96.0% in the 5th (highest) quintile. The prefecture-level indicators in the NDB and the 630 survey had correlations of >0.70. CONCLUSIONS: Our study provides fundamental information on resource use of new psychiatric admissions in Japan. Although using the NDB has substantial benefits in monitoring resource use, the results should be interpreted with some caution owing to methodological issues inherent in the database.

The recognition and expectations of ex-inpatients of mental health services: A web-based questionnaire survey in Japan.

Concern about mental health issues and the treatment of mentally disordered offenders attracts considerable public attention. This study aimed to gather the experiences and opinions of people who have experienced admission to a psychiatric ward in order to grasp their reaction to, and understanding of, the legislation behind the involuntary admission of psychiatric patients. A web-based questionnaire survey was conducted with a total of 379 participants, using a cross-sectional, exploratory design. The data were analyzed using a chi-squared test, Fisher's exact test, and a logistic regression analysis. According to the results, many patients were satisfied with their treatment during psychiatric admission; however, only few participants said that they had been given an adequate explanation for their involuntary treatment. Most participants expected qualified assistance after discharge, although the prospect of a regular visit from an official was not entirely supported by the participants. Patient satisfaction was relevant to the discussion of their needs after discharge and in developing a crisis plan during admission. These findings suggest that psychiatric patients accept inpatient treatment as long as they receive an adequate explanation. More qualified care such as relapse prevention would be expected to lead to better satisfaction. For them to welcome regular visits from an official, patients may need more information and discussion.

Timely follow-up visits after psychiatric hospitalization and readmission in schizophrenia and bipolar disorder in Japan.

The study objective was to investigate the association between timely follow-up visits after psychiatric hospitalization and the risk of readmission in patients with schizophrenia or bipolar disorder. A retrospective cohort study was conducted using a nationwide claims database in Japan. Between April 2014 and March 2015, all psychiatric hospitalization data were obtained and patients with a principal diagnosis of schizophrenia or bipolar disorder were followed up from 180 days before admission to 210 days after discharge. The primary outcome of this study was psychiatric readmission during the 180-day period (between 31 and 210 days) after the index discharge. A total of 48,579 eligible patients were identified. After psychiatric hospitalization, 15% of patients received no follow-up visits to a psychiatrist within 30 days. Patients who received follow-up visits had lower readmission rates during the subsequent 180 days (21.7% vs. 37.5%; adjusted risk ratio, 0.54 [95% confidence interval, 0.52-0.57]) than those who did not. Timely follow-up visits after discharge could be helpful for reducing the readmission risk in patients.

Switching and augmentation strategies for antipsychotic medications in acute-phase schizophrenia: latest evidence and place in therapy.

In terms of effectiveness of antipsychotics in schizophrenia, discrepancy often exists between results from double-blind randomized controlled trials and observations in emergency or acute-phase clinical practice. For instance, the antipsychotic switching strategy is not always applicable in emergency or acute-phase situations, and augmentation of another antipsychotic is occasionally done instead. In this review, we discuss strategies for early nonresponse to an antipsychotic drug such as switching and augmentation from the perspective of emergency and acute-phase treatment. We searched PubMed for the latest evidence on switching and augmentation strategies of antipsychotics for an emergency or acute-phase period. For risperidone and olanzapine, there is some evidence on switching and augmentation strategies in the management of acute-phase schizophrenia. There may be responders to olanzapine alone among early nonresponders to risperidone, whereas there may be few responders to risperidone alone among early nonresponders to olanzapine. However, there is still insufficient evidence at this time for application of these findings to routine clinical practice. For other antipsychotics, there is little evidence for their augmentation in acute-phase practice. We should be wary of polypharmacy, as multiple agents are too often prescribed by clinicians when not warranted. Considering current evidence, we propose how to switch antipsychotics in the acute phase of schizophrenia in routine practice.

Association of high psychiatrist staffing with prolonged hospitalization, follow-up visits, and readmission in acute psychiatric units: a retrospective cohort study using a nationwide claims database.

BACKGROUND: The effects of psychiatrist staffing are unclear. The aim of this study was to assess the association of high psychiatrist staffing with prolonged hospitalization, follow-up visits, and readmission in acute psychiatric units. METHODS: A retrospective cohort study was conducted using the National Database of Health Insurance Claim Information and Specified Medical Checkups. Patients newly admitted to acute psychiatric units between October 2014 and September 2015 were followed up until September 2016. The primary exposure was a patient-to-psychiatrist ratio of 16:1 (high-staffing units) vs 48:1 (low-staffing units). Outcomes were prolonged hospitalization of >90 days, number of follow-up psychiatric visits within 90 days after discharge, and psychiatric readmission within 90 days after discharge. Incidence rate ratios (IRRs) and their 95% confidence intervals (CIs) were estimated by using generalized estimating equations, adjusting for potential covariates. RESULTS: Among the 24,678 newly admitted patients at 190 hospitals, 13,138 patients (53.2%) were admitted to high-staffing units in 92 hospitals. After adjustment, high-staffing units were associated with a lower risk of prolonged hospitalization (incidence rate, 16.9 vs 21.3%; IRR, 0.79 [95% CI, 0.70, 0.89]), higher number of follow-up visits (incidence rate of ≥7 visits, 16.9 vs 13.4%; IRR, 1.06 [95% CI, 1.01, 1.12]), and lower risk of readmission (incidence rate, 13.0 vs 14.4%; IRR, 0.90 [95% CI, 0.82, 0.99]). CONCLUSION: High-staffing units are associated with a reduced risk of prolonged hospitalization and readmission and an increased number of follow-up visits. Further research is needed to improve the generalizability of these findings and establish the optimal level of staffing.

Evaluation of cognitive and social functioning in patients requiring long-term inpatient psychiatric care using the International Classification of Functioning, Disability, and Health: a large-scale, multi-institutional observational study.

PURPOSE: We comprehensively evaluated cognitive and social functioning in patients requiring long-term inpatient psychiatric care using the International Classification of Functioning, Disability, and Health. METHOD: We surveyed 1967 patients receiving long-term inpatient psychiatric care. Patients were further categorized into an old long-stay group (n = 892, >5 years in hospitals) and a new long-stay group (n = 1075, 1-5 years in hospitals). We obtained responses for all the International Classification of Functioning, Disability, and Health items in domain b (Body Functions) and domain d (Activities and Participation). We estimated weighted means for each item using the propensity score to adjust for confounding factors. RESULTS: Responses were received from 307 hospitals (response rate of hospitals: 25.5%). Cognitive and social functioning in the old long-stay group was more severely impaired than in the new long-stay group. No statistically significant differences were observed regarding the International Classification of Functioning, Disability, and Health items associated with basic activities of daily living between the two groups. CONCLUSION: Combined therapy consisting of cognitive remediation and rehabilitation on social functioning for this patient population should be started from the early stage of hospitalization. Non-restrictive, independent environments may also be optimal for this patient population. Implications for rehabilitation Rehabilitation of cognitive and social functioning for patients requiring long-term inpatient psychiatric care should be started in the early stages of hospitalization. In psychiatric fields, the International Classification of Functioning, Disability, and Health checklist could facilitate individualized rehabilitation planning by allowing healthcare professionals to visually assess the comprehensive functioning of each patient using graphics such as radar charts.

Intracranial self-stimulation-reward induces neurite extension in PC12m3 cells and activation of the p38 MAPK pathway.

Factors that trigger emotional expression may be divided into two patterns according to the type of motivation, acquiring reward (pleasure) and avoiding aversion (punishment). Repeated exposure to certain external stimuli accompanied by aberrant motivation may produce psychiatric diseases such as bipolar disorder and addiction via dysregulation of the central nervous system. However, neurobiological underpinnings of such diseases have not been clarified, especially at the neuronal level. In the present study, plasma from rats undergoing intracranial self-stimulation (ICSS) produced neurite outgrowth in PC12-variant cells (PC12m3). Stimulated PC12m3 cells also exhibited heightened activity of the p38 MAPK pathway. These findings indicate that reward states lead to not only morphological changes but also increases in p38 MAPK activity at the neuronal level in the central nervous system.

Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial.

BACKGROUND: The feasibility of shared decision making (SDM) for patients with schizophrenia remains controversial due to the assumed inability of patients to cooperate in treatment decision making. This study evaluated the feasibility and efficacy of SDM in patients upon first admission for schizophrenia. METHODS: This was a randomized, parallel-group, two-arm, open-label, single-center study conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. Patients with the diagnosis of schizophrenia upon their first admission were randomized into a SDM intervention group or a usual treatment group in a 1:1 ratio. The primary outcome was patient satisfaction at discharge. The secondary outcomes were attitudes toward medication at discharge and treatment continuation at 6 months after discharge. RESULTS: Twenty-four patients were randomly assigned. The trial was prematurely terminated due to slow enrollment. At discharge, the mean score on satisfaction was 23.7 in the SDM group and 22.1 in the usual care group (unadjusted mean difference: 1.6; 95% CI: -5.2 to 2.0). Group differences were not observed in attitude toward medication and treatment continuation. There was no statistically significant difference between the groups for the mean Global Assessment of Functioning score at discharge or length of stay as safety endpoint. CONCLUSIONS: No statistical differences were found between the SDM group and usual care group in the efficacy outcomes and safety endpoints. Large trials are needed to confirm the efficacy of the SDM program upon first admission for schizophrenia. TRIAL REGISTRATION: The study has been registered with ClinicalTrials.gov as NCT01869660 (registered 27 May, 2013).

Characteristics of aggression among psychiatric inpatients by ward type in Japan: Using the Staff Observation Aggression Scale - Revised (SOAS-R).

Aggressive behaviour by psychiatric patients is a serious issue in clinical practice, and adequate management of such behaviour is required, with careful evaluation of the factors causing the aggression. To examine the characteristics of aggressive incidents by ward type, a cross-sectional descriptive study was conducted for 6 months between April 2012 and June 2013 using the Staff Observation Aggression Scale - Revised, Japanese version (SOAS-R) in 30 wards across 20 Japanese psychiatric hospitals. Participating wards were categorized into three types based on the Japanese medical reimbursement system: emergency psychiatric, acute psychiatric, and standard wards (common in Japan, mostly treating non-acute patients). On analyzing the 443 incidents reported, results showed significant differences in SOAS-R responses by ward type. In acute and emergency psychiatric wards, staff members were the most common target of aggression. In acute psychiatric wards, staff requiring patients to take medication was the most common provocation, and verbal aggression was the most commonly used means. In emergency psychiatric wards, victims felt threatened. In contrast, in standard wards, both the target and provocation of aggression were most commonly other patients, hands were used, victims reported experiencing physical pain, and seclusion was applied to stop their behaviour. These findings suggest that ward environment was an important factor influencing aggressive behaviour. Ensuring the quality and safety of psychiatric care requires understanding the characteristics of incidents that staff are likely to encounter in each ward type, as well as implementing efforts to deal with the incidents adequately and improve the treatment environment.

Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial.

BACKGROUND: Shared decision making is a promising model for patient-centred medicine, resulting in better clinical outcomes overall. In the mental health field, interventions that consider the patient-centred perspective--such as patient quality of life, involvement in the treatment, treatment satisfaction, and working alliance--have increased and better clinical outcomes discovered for patients with schizophrenia. However, few studies have examined the efficacy of shared decision making for schizophrenia treatment. The objective of this study is to evaluate the effect of a shared decision making intervention compared to treatment as usual on patient satisfaction at discharge for first-admission patients with schizophrenia. METHODS/DESIGN: This is a randomised, parallel-group, two-arm, open-label, single-centre study currently being conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. We are recruiting patients between 16 and 65 years old who are admitted to the ward with a diagnosis of schizophrenia without prior experience of psychiatric admission. Fifty-eight participants are being randomised into a shared decision making intervention group or a treatment as usual control group in a 1:1 ratio. The intervention program was developed based on a shared decision making model and is presented as a weekly course lasting the duration of the patients' acute psychiatric ward stay. The primary outcome measure is patient satisfaction at discharge as assessed by the Client Satisfaction Questionnaire. Due to the study's nature, neither the patient nor staff can be blinded. DISCUSSION: This is the first randomised controlled trial to evaluate the efficacy of shared decision making for patients with early-treatment-stage schizophrenia. The intervention program in this study is innovative in that it includes both of the patient and staff who are involved in the treatment. TRIAL REGISTRATION: The study has been registered with ClinicalTrials.gov as NCT01869660.

Influence of patient characteristics on duration of seclusion/restrain in acute psychiatric settings in Japan.

AIM: The aim of this study was to investigate the current state of duration of seclusion/restraint in acute psychiatric settings in Japan and the effect of patient characteristics on duration of seclusion/restraint. METHODS: During an 8-month period starting from November 2008, duration of seclusion/restraint and patient characteristics were investigated in 694 psychiatric inpatients who experienced seclusion/restraint in three emergency and three acute wards at four psychiatric hospitals. Reasons for starting seclusion/restraint were also assessed. Analysis was performed using generalized linear models, with the duration of seclusion/restraint as the dependent variable and patient characteristics and reasons for starting seclusion/restraint as independent variables. RESULTS: Of the patients secluded/restrained, 58.6% had a primary diagnosis of schizophrenia (F20-F29) and a large proportion (37.9%) were secluded/restrained due to hurting others. Median hours ofseclusion/restraint were 204 and 82 h, respectively. The duration of seclusion was longer for patients with F20-F29 than those with disorders due to psychoactive substance use (F10-F19) or other diagnoses (F40-F99), and when the reason was danger of hurting others. In contrast, the duration of restraint in female patients and in patients with F10-F19 diagnosis was shorter. CONCLUSION: The duration of seclusion/restraint at acute psychiatric care wards in Japan are much longer than those reported by previous overseas studies. Although Japanese structure issues such as more patients per ward and a lower ratio of nurses need to be considered, skills for dealing with patients with primary diagnosis of F20-F29 secluded due to danger posed to others should be improved.

A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation.

BACKGROUND: Olanzapine rapid-acting intramuscular (IM) injection is an atypical antipsychotic drug already used overseas and recently approved in Japan. The objective of this study was to confirm the efficacy of rapid-acting IM olanzapine 10 mg was greater than IM placebo in patients with exacerbation of schizophrenia with acute psychotic agitation by comparing changes from baseline to 2 hours after the first IM injection, as measured by the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) total score. METHODS: We conducted a placebo-controlled, randomized, double-blind, parallel-group study in Japanese patients diagnosed with schizophrenia according to the diagnostic criteria specified in the DSM-IV-TR. Patients were randomized to 2 treatment groups: IM olanzapine (10 mg) or IM placebo. The primary efficacy outcome was the change in PANSS-EC from baseline to 2 hours after the first IM injection. Treatment groups were compared with an analysis of variance model which included treatment and site as factors. During the 24-hour treatment period, safety was assessed by clinical examination and laboratory investigations, electrocardiograms, extrapyramidal symptoms scales, and recording spontaneously reported adverse events. RESULTS: Of the 91 randomized patients, 90 patients (45 IM olanzapine-group; 45 IM placebo-group) were in the full analysis set. The mean change of PANSS-EC total score from baseline to 2 hours after the first IM injection (mean±standard deviation) was -9.2±4.5 for the IM olanzapine group and -2.8±5.6 for the IM placebo group. The difference between treatment groups was statistically significant (p<.001). There were no deaths, serious adverse events, treatment-emergent adverse events (TEAEs) leading to discontinuation, severe TEAEs, or instances of oversedation in this study. There were no statistically significant differences between treatment groups in the proportion of patients with potentially clinically significant changes in laboratory tests, vital signs (blood pressure and pulse rate), electrocardiograms, and treatment-emergent extrapyramidal symptoms. CONCLUSION: The efficacy of IM olanzapine 10 mg in patients with exacerbation of schizophrenia with acute psychotic agitation was greater than IM placebo in the primary efficacy measure, PANSS-EC. Intramuscular olanzapine 10 mg was shown to be generally safe and tolerable, and could be a new option for treatment of schizophrenia in Japan. TRIAL REGISTRATION: NCT00970281.

Secluded/restrained patients' perceptions of their treatment: validity and reliability of a new questionnaire.

AIM: To develop a standardized self-reporting questionnaire to evaluate patients' perceptions of their overall treatment in specific relation to the use of seclusion and/or restraint (SR) measures as part of the treatment program. METHODS: A 17-item self-rating questionnaire was given to 56 patients with experience of SR-related treatment to develop a new scale, the Secluded/Restrained Patients' Perceptions of their Treatment (SR-PPT). Concurrent validity was examined against the Client Satisfaction Questionnaire-8 Japanese Version (CSQ-8J). In addition, Patient burden induced by answering the SR-PPT was evaluated. RESULTS: On factor analysis, two factors named as Cooperation with Staff (nine items) and Perceptions of SR (two items) were derived. Cronbach's coefficient alphas were 0.928 and 0.887, and correlation coefficients against the CSQ-8J were 0.838 and 0.609, respectively. Answering the SR-PPT was found to induce little burden on the patients. CONCLUSION: Adequate internal consistency and concurrent validity of the final version of the SR-PPT, which consists of 11 items, indicate that it is acceptable as a measurement scale. Use of this questionnaire will add the patient's view to the assessment of overall treatment involving SR.