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 of seclusion/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.

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BackgroundOlanzapine 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.MethodsWe 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.ResultsOf 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.ConclusionThe 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 RegistrationNCT00970281

BackgroundThe 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.MethodsThis 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.ResultsTwenty-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.ConclusionsNo 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 registrationThe study has been registered with ClinicalTrials.gov as NCT01869660 (registered 27 May, 2013).

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.

BackgroundShared 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/DesignThis 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.DiscussionThis 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 registrationThe study has been registered with ClinicalTrials.gov as NCT01869660.

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.

We report a mutational and polymorphic analysis of the proteolipid protein gene in members of 27 Japanese families with Pelizaeus‐Merzbacher disease. We found causative mutations in 6 members of 27 families (22.2%); 5 of the 6 mutations, including two novel mutations, Leu45Arg and 231 + 2T → G, resulted in the typically severe clinical symptoms. Paradoxically, the Cys219Tyr mutation, presumed to disrupt the tertiary structure of proteolipid protein by removing the disulfide bond between Cys200 and Cys219, was associated with a mild clinical presentation wherein the patient could walk with assistance and speak. It was inferred that the structural change prevented the toxicity associated with a gain of function mutation. Moreover, in one family 3 patients exhibited a intragenic polymorphism that did not segregate with the disease, suggesting a locus heterogeneity for Pelizaeus‐Merzbacher disease. Ann Neurol 1999;45:59–64