研究者詳細 - 菊地　俊暁

論文 - 菊地　俊暁

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Understanding psychiatric illness through natural language processing (UNDERPIN): Rationale, design, and methodology

Kishimoto T., Nakamura H., Kano Y., Eguchi Y., Kitazawa M., Liang K.C., Kudo K., Sento A., Takamiya A., Horigome T., Yamasaki T., Sunami Y., Kikuchi T., Nakajima K., Tomita M., Bun S., Momota Y., Sawada K., Murakami J., Takahashi H., Mimura M.

Frontiers in Psychiatry 13 2022年12月

Introduction: Psychiatric disorders are diagnosed through observations of psychiatrists according to diagnostic criteria such as the DSM-5. Such observations, however, are mainly based on each psychiatrist's level of experience and often lack objectivity, potentially leading to disagreements among psychiatrists. In contrast, specific linguistic features can be observed in some psychiatric disorders, such as a loosening of associations in schizophrenia. Some studies explored biomarkers, but biomarkers have yet to be used in clinical practice. Aim: The purposes of this study are to create a large dataset of Japanese speech data labeled with detailed information on psychiatric disorders and neurocognitive disorders to quantify the linguistic features of those disorders using natural language processing and, finally, to develop objective and easy-to-use biomarkers for diagnosing and assessing the severity of them. Methods: This study will have a multi-center prospective design. The DSM-5 or ICD-11 criteria for major depressive disorder, bipolar disorder, schizophrenia, and anxiety disorder and for major and minor neurocognitive disorders will be regarded as the inclusion criteria for the psychiatric disorder samples. For the healthy subjects, the absence of a history of psychiatric disorders will be confirmed using the Mini-International Neuropsychiatric Interview (M.I.N.I.). The absence of current cognitive decline will be confirmed using the Mini-Mental State Examination (MMSE). A psychiatrist or psychologist will conduct 30-to-60-min interviews with each participant; these interviews will include free conversation, picture-description task, and story-telling task, all of which will be recorded using a microphone headset. In addition, the severity of disorders will be assessed using clinical rating scales. Data will be collected from each participant at least twice during the study period and up to a maximum of five times at an interval of at least one month. Discussion: This study is unique in its large sample size and the novelty of its method, and has potential for applications in many fields. We have some challenges regarding inter-rater reliability and the linguistic peculiarities of Japanese. As of September 2022, we have collected a total of >1000 records from >400 participants. To the best of our knowledge, this data sample is one of the largest in this field. Clinical Trial Registration: Identifier: UMIN000032141.

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Central monitoring of depression and anxiety symptoms reduces placebo responses in depression clinical trials: A post hoc exploratory analysis of data from the phase III CCT-004 trial of vortioxetine

Watanabe Y., Nishimura A., Kikuchi T., Sawada N., Imazaki M., Inada I., Watanabe K.

Neuropsychopharmacology Reports 42 （ 4 ） 468 - 477 2022年12月

Aim: Clinical trials of antidepressants often fail to demonstrate their efficacy versus placebo, suggesting that patient selection based on physician ratings of depression may contribute to a high placebo response. Methods: In the CCT-004 trial of vortioxetine, central monitoring was employed to compare physician and patient ratings of depression and anxiety at baseline and over time to identify factors contributing to a large placebo response, as well as to explore the potential of a unique patient-rated clinical measure combining QIDS-J and Himorogi Self-rating Anxiety Scale (HSAS), to contribute to optimal patient selection at baseline and patient monitoring over time. Results: The CCT-004 trial showed similar trends between the QIDS-J and MADRS (Montgomery-Åsberg Depression Rating Scale) ratings. It was suggested that central monitoring of the QIDS-J and MADRS ratings of depression and anxiety symptoms helped reduce the baseline score inflation by calling the study sites' attention to discrepancies between these ratings at baseline; it also allowed these ratings to be assessed for their concordance over time. Of note, MDD patients with baseline QIDS-J scores ≥11/HSAS ≤19 were associated with the smallest placebo response, with the effect size being larger than that for those with QIDS-J scores ≤10/HSAS ≥20. Conclusion: The use of both physician and patient ratings of depression and anxiety symptoms at baseline and over time, as well as their central monitoring, helped minimize the baseline score inflation and optimize patient monitoring over time, and allowed the antidepressant to be evaluated for its full therapeutic potential.

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Effect of age and sex on prescriptions for outpatients with bipolar disorder in the MUSUBI study: a cross‑sectional study

Kawamata Y., Yasui-Furukori N., Adachi N., Ueda H., Hongo S., Azekawa T., Kubota Y., Katsumoto E., Edagawa K., Goto E., Miki K., Kato M., Nakagawa A., Kikuchi T., Tsuboi T., Yoshimura R., Shimoda K., Watanabe K.

Annals of General Psychiatry 21 （ 1 ） 2022年12月

Background: Childbearing-aged female patients and elderly patients with bipolar disorder need special attention for pharmacological treatments, but current guidelines provide little information on their pharmacological treatment. In particular, the risk/benefit balance of pharmacological treatment for childbearing-aged females with bipolar disorder is a growing concern. Therefore, we aimed to address the effect of age and sex on psychotropic drug prescription for outpatients with bipolar disorder. Methods: The MUlticenter treatment SUrvey for BIpolar disorder in Japanese psychiatric clinics (MUSUBI) study was conducted, and data on age, sex, and details of pharmacological treatment were collected. Results: A total of 3106 outpatients were included in this study. Among young females (age ≤ 39), 25% were prescribed valproate. There was no significant difference in the frequency and daily dose of valproate prescription for young females among all groups. Valproate prescriptions were significantly less frequent among young males and more frequent among middle-aged males. Lithium prescriptions were significantly less frequent among young females and more frequent among older males (age ≥ 65) and older females. Lamotrigine prescriptions were significantly more frequent among young males and young females and less frequent among older males and older females. Carbamazepine prescriptions were significantly less frequent among young males and more frequent among older males. Conclusions: Biased information about the risk and safety of valproate and lithium for young females was suggested, and further study to correct this bias is needed. Older patients were prescribed lithium more commonly than lamotrigine. Further studies are needed to determine the actual pharmacotherapy for elderly individuals.

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Determinants of three-year clinical outcomes in real-world outpatients with bipolar disorder: The multicenter treatment survey for bipolar disorder in psychiatric outpatient clinics (MUSUBI)

Sugawara N., Adachi N., Kubota Y., Watanabe Y., Miki K., Azekawa T., Edagawa K., Katsumoto E., Hongo S., Goto E., Ueda H., Kato M., Yoshimura R., Nakagawa A., Kikuchi T., Tsuboi T., Watanabe K., Shimoda K., Yasui-Furukori N.

Journal of Psychiatric Research 151 683 - 692 2022年07月

ISSN 00223956

Background: There is limited evidence regarding predictors of long-term clinical outcomes in patients with bipolar disorder (BD). The objective of this study was to describe 3-year clinical outcomes and identify their predictors from participants in the multicenter treatment survey for BD in psychiatric outpatient clinics (MUSUBI). Methods: The MUSUBI was a naturalistic study investigating patients with BD in real-world clinical practice. Our study extracted data regarding 1647 outpatients with BD from 2016, 2017, and 2019 as baseline, 1-year, and 3-year assessments. As clinical outcomes, we assessed the presence of time ill (depressive and manic) during the 1 year prior to the 3-year assessment and durable remission (53 weeks or more) prior to the 3-year assessment. Results: Participants with durable remission prior to the 3-year assessment had significant associations with diagnosis of a personality disorder and duration of continuous remission at baseline. Regarding the presence of depressive symptoms during the 1 year prior to the 3-year assessment, work status, Global Assessment of Functioning (GAF) scores, suicidal ideation, and duration of continuous remission at baseline had significant associations with this outcome. Conclusions: At the 3-year assessment, 19.3% of participants (318/1647) achieved durable remission, while 47.5% of them (782/1647) were not remitted. Our findings can help clinicians predict the illness course of BD by understanding demographic and clinical characteristics.

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Cognitive behavioral therapy effects on frontopolar cortex function during future thinking in major depressive disorder: A randomized clinical trial

Katayama N., Nakagawa A., Umeda S., Terasawa Y., Abe T., Kurata C., Sasaki Y., Mitsuda D., Kikuchi T., Tabuchi H., Mimura M.

Journal of Affective Disorders 298 644 - 655 2022年02月

ISSN 01650327

Background: Despite the importance of Beck's theoretical cognitive model of psychopathology, the neural mechanisms underlying future thinking in cognitive behavioral therapy (CBT) remain elusive. Recent neuroimaging studies have shown that the function of the frontopolar cortex (Brodmann area 10 [BA10]) is associated with future thinking. We hypothesized that, compared with unstructured psychotherapy (talking control: TC), CBT may involve different neural responses in BA10 associated with future thinking. Methods: This randomized clinical trial included 38 adult patients with moderate-to-severe major depressive disorder who underwent up to 16 weeks of CBT or TC with a 6-month follow-up period. We evaluated changes in BA10 activation during distant future thinking using functional magnetic resonance imaging with a future-thinking task. We assessed frontal neurocognitive function and clinical symptoms at baseline and post-treatment. Depression severity and automatic thoughts were assessed at the 6-month follow-up. Results: We found decreased activation in the frontopolar cortex during distant future thinking after CBT (t = 3.00, df=15, p = 0.009) and no changes after TC. Further, the reduction in BA10 activity significantly correlated with changes in frontal cognitive function after the treatment (r = 0.48, p = 0.007), and in positive automatic thought after 6 months of treatments (r = 0.39; p = 0.03). Limitations: Relatively small sample size and homogenous clinical profile could limit the generalizability. Patients received pharmacotherapy including antidepressant. Conclusions: CBT appears to improve frontopolar cortex function during future thinking in a manner distinct from TC. Larger clinical trials are necessary to provide firm evidence whether BA10 activity may serve as a neuro-marker for monitoring successful depression treatment with CBT.

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Differences in prescription patterns between real-world outpatients with bipolar I and II disorders in the MUSUBI survey

Shinozaki M., Yasui-Furukori N., Adachi N., Ueda H., Hongo S., Azekawa T., Kubota Y., Katsumoto E., Edagawa K., Goto E., Miki K., Kato M., Nakagawa A., Kikuchi T., Tsuboi T., Watanabe K., Shimoda K., Yoshimura R.

Asian Journal of Psychiatry 67 2022年01月

ISSN 18762018

Objective: There is limited information available on the prescription of psychotropic agents to patients with bipolar I (BD-I) and bipolar II disorder (BD-II). The purpose of this study was to investigate the characteristics of drug therapy in BD-I and BD-II outpatients, particularly with regard to antidepressants. Methods: In 2017, the MUlticenter treatment SUrvey for BIpolar disorder in Japanese psychiatric clinics (MUSUBI) study collected data on current mental status, medications, and other factors from 2774 outpatients with BD-I or BD-II. Results: There were significant differences in the rates of prescriptions for mood stabilizers, antipsychotics and antidepressants. Mood stabilizers and antipsychotics were prescribed at higher rates to patients with BD-I (mood stabilizers; BD-I 86.0%, BD-II 80.8%, p < 0.001; antipsychotics; BD-I 61.5%, BD-II 47.8%, p < 0.001), and antidepressants were prescribed at higher rates to patients with BD-II (BD-I 32.1%, BD-II 46.4%, p < 0.001). The most commonly prescribed antidepressants were escitalopram for patients with BD-I and duloxetine for patients with BD-II. Selective serotonin reuptake inhibitors (SSRIs) were the most common class of antidepressants prescribed to patients with BD. With regard to combination therapy, combinations containing antidepressants were often prescribed to patients with BD-II. Conclusion: There was a difference in the prescription of psychotropic agents between patients with BD-I and BD-II. The outpatient prescriptions for BD in Japan were mood stabilizers and antipsychotics, which generally followed the guidelines. There is insufficient evidence regarding the effects of the prescribed antidepressants and the risk of manic episodes, and further evidence needs to be collected.

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Relationship Between Employment Status and Unstable Periods in Outpatients with Bipolar Disorder: A Multicenter Treatment Survey for Bipolar Disorder in Psychiatric Outpatient Clinics (MUSUBI) Study

Ikenouchi A., Konno Y., Fujino Y., Adachi N., Kubota Y., Azekawa T., Ueda H., Edagawa K., Katsumoto E., Goto E., Hongo S., Kato M., Tsuboi T., Yasui-Furukori N., Nakagawa A., Kikuchi T., Watanabe K., Yoshimura R.

Neuropsychiatric Disease and Treatment 18 801 - 809 2022年

Purpose: To clarify the relationship between the length of unstable periods and employment status of patients with bipolar disorder. Patients and Methods: Medical records of outpatients with bipolar disorder who visited 176 member clinics of the Japanese Association of Neuro-Psychiatric Clinics were investigated during September–October 2016, and details of their medical care and employment were surveyed using a questionnaire. The odds ratios (ORs) of length of unstable period and unemployment were analyzed with a logistic regression model. Results: The study included 816 patients, of whom 707 were employed full-time (continuous employment) and 70 were unemployed (loss of employment). Univariate analysis showed that ORs were statistically significant for patients who were unstable for “almost all” of the year (OR = 10.4 [4.48–24.28] p < 0.001), but not for “few” unstable periods (OR = 1.06 [0.56–1.98] p = 0.849) and for “significant” unstable periods (OR = 1.65 [0.73–3.74] p = 0.231) were not significantly different. Multivariate analysis showed that ORs were statistically “significant” for patients who were unstable for “almost all” (OR = 12.1 [4.37–33.3] p < 0.001), but not for “few” unstable periods (OR = 1.07 [0.55–2.07] p = 0.846) and for “significant” unstable periods (OR = 1.62 [0.66–3.98] p = 0.290) did not differ significantly. Conclusion: Patients with bipolar disorder with a long unstable period were associated with a higher risk of unemployment.

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Japanese project for telepsychiatry evaluation during COVID-19: Treatment comparison trial (J-PROTECT): Rationale, design, and methodology

Kishimoto T., Kinoshita S., Bun S., Sato Y., Kitazawa M., Kikuchi T., Sado M., Takamiya A., Mimura M., Nakamae T., Abe Y., Kanazawa T., Kawabata Y., Tomita H., Abe K., Hishimoto A., Asami T., Suda A., Watanabe Y., Amagai T., Sakuma K., Kida H., Funayama M., Kimura H., Sato A., Fujiwara S., Nagao K., Sugiyama N., Takamiya M., Kodama H., Azekawa T.

Contemporary Clinical Trials 111 2021年12月

ISSN 15517144

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).

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Real-world clinical predictors of manic/hypomanic episodes among outpatients with bipolar disorder

Tokumitsu K., Norio Y.F., Adachi N., Kubota Y., Watanabe Y., Miki K., Azekawa T., Edagawa K., Katsumoto E., Hongo S., Goto E., Ueda H., Kato M., Nakagawa A., Kikuchi T., Tsuboi T., Watanabe K., Shimoda K., Yoshimura R.

Plos One 16 （ 12 December ） 2021年12月

Background Bipolar disorder is a mental illness in which manic and depressive states are repeated, causing psychosocial dysfunction. Manic/hypomanic episodes cause problems with interpersonal, social and financial activities, but there is limited evidence regarding the predictors of manic/hypomanic episodes in real-world clinical practice. Methods The multicenter treatment survey on bipolar disorder (MUSUBI) in Japanese psychiatric clinics was administered in an observational study that was conducted to accumulate evidence regarding bipolar disorder in real-world clinical practice. Psychiatrists were asked to complete a questionnaire about patients with bipolar disorder who visited 176 member clinics of the Japanese Association of Neuro-Psychiatric Clinics by conducting a retrospective medical record survey. Our study extracted baseline patient characteristics from September to October 2016, including comorbidities, mental status, duration of treatment, Global Assessment of Functioning (GAF) score, and pharmacological treatment details. We investigated the presence or absence of manic/hypomanic episodes over the course of one year from baseline to September-October 2017. Results In total, 2231 participants were included in our study, 29.1% of whom had manic/hypomanic episodes over the course of one year from baseline. Binomial logistic regression analysis revealed that the presence of manic/hypomanic episodes was correlated with lower baseline GAF scores, rapid cycling, personality disorder, bipolar I disorder, and a mood state with manic or mixed features. Substance abuse was also a risk factor for manic episodes. There was no significant association between a baseline antidepressant prescription and manic/hypomanic episodes. Conclusions In Japan, 29.1% of outpatients with bipolar disorder had manic/hypomanic episodes over the course of one year. Our study suggested that a low GAF score, rapid cycling, personality disorder, bipolar I disorder, substance abuse, and baseline mood state could be predictors of manic/hypomanic episodes. Based on our findings, an antidepressant prescription is not a predictor of manic/hypomanic episodes.

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Association of electroconvulsive therapy-induced structural plasticity with clinical remission

Takamiya A., Kishimoto T., Hirano J., Kikuchi T., Yamagata B., Mimura M.

Progress in Neuro-Psychopharmacology and Biological Psychiatry （Progress in Neuro-Psychopharmacology and Biological Psychiatry） 110 2021年08月

ISSN 02785846

Background: Electroconvulsive therapy (ECT) is the most effective treatment for severe depression. Recent neuroimaging studies have consistently reported that ECT induces volume increases in widely distributed brain regions. However, it still remains unclear about ECT-induced volume changes associated with clinical improvement. Methods: Longitudinal assessments of structural magnetic resonance imaging were conducted in 48 participants. Twenty-seven elderly melancholic depressed individuals (mean 67.5 ± 8.1 years old; 19 female) were scanned before (TP1) and after (TP2) ECT. Twenty-one healthy controls were also scanned twice. Whole-brain gray matter volume (GMV) was analyzed via group (remitters, nonremitters, and controls) by time (TP1 and TP2) analysis of covariance to identify ECT-related GMV changes and GMV changes specific to remitters. Within-subject and between-subjects correlation analyses were conducted to investigate the associations between clinical improvement and GMV changes. Depressive symptoms were evaluated using the 17-item Hamilton Depression Rating Scale (HAM-D), and remission was defined as HAM-D total score ≤ 7. Results: Bilateral ECT increased GMV in multiple brain regions bilaterally regardless of clinical improvement. Remitters showed a larger GMV increase in the right-lateralized frontolimbic brain regions compared to nonremitters and healthy controls. GMV changes in the right hippocampus/amygdala and right middle frontal gyrus showed correlations with clinical improvement in within−/between-subjects correlation analyses. Conclusions: ECT-induced GMV increase in the right frontolimbic regions was associated with clinical remission.

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Antipsychotic Polypharmacy Is Associated with Adverse Drug Events in Psychiatric Inpatients: The Japan Adverse Drug Events Study

Ayani N., Morimoto T., Sakuma M., Kikuchi T., Watanabe K., Narumoto J.

Journal of Clinical Psychopharmacology （Journal of Clinical Psychopharmacology） 41 （ 4 ） 397 - 402 2021年07月

ISSN 02710749

Background Antipsychotic (AP) polypharmacy (APP), the coprescription of more than 1 AP, is frequently practiced in psychiatric inpatients and is considered to be a risk factor for adverse drug events (ADEs). However, the association between APP and ADEs among psychiatric inpatients has not been well investigated. Methods The Japan Adverse Drug Events (JADE) study was a series of cohort studies conducted in several clinical settings. In particular, the JADE study for psychiatric inpatients was a retrospective cohort study of 448 psychiatric inpatients with a cumulative 22,733 patient-days. We investigated the relationship between APP, defined as a concurrent prescription of 2 or more APs and ADEs. We also assessed the relationship between potential risk factors for ADEs due to APs. Results Among the 448 patients included in this study, 106 patients (24%) had APP and the remaining 342 patients were prescribed 1 AP or none. Risperidone was the most frequent drug (25%, 109/442 AP prescriptions) used, and levomepromazine was most frequently prescribed as a concurrent medication with other APs (91%, 29/32). The median number of ADEs among the patients with APP was significantly higher than in those without APP (P = 0.001). Antipsychotic polypharmacy was a risk factor for the occurrence of first (adjusted hazard ratio, 1.54; 95% confidence interval, 1.15-2.04) and second (adjusted hazard ratio, 1.99; 95% confidence interval, 1.40-2.79) ADEs. Conclusions Antipsychotic polypharmacy was a risk factor for the occurrence of single and multiple ADEs. Antipsychotic polypharmacy should be conservatively and minimally practiced.

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Does cognitive behavioral therapy for anxiety disorders assist the discontinuation of benzodiazepines among patients with anxiety disorders? A systematic review and meta-analysis

Takeshima M., Otsubo T., Funada D., Murakami M., Usami T., Maeda Y., Yamamoto T., Matsumoto T., Shimane T., Aoki Y., Otowa T., Tani M., Yamanaka G., Sakai Y., Murao T., Inada K., Yamada H., Kikuchi T., Sasaki T., Watanabe N., Mishima K., Takaesu Y.

Psychiatry and Clinical Neurosciences （Psychiatry and Clinical Neurosciences） 75 （ 4 ） 119 - 127 2021年04月

ISSN 13231316

Long-term use of benzodiazepines (BZD) is not recommended for the treatment of anxiety disorders. Cognitive behavioral therapy (CBT) is an effective treatment option for discontinuation of BZD in patients with anxiety disorders. This systematic review and meta-analysis sought to clarify whether CBT is effective for discontinuing BZD anxiolytics in patients with anxiety disorders. This study was preregistered with PROSPERO (registration number: CRD42019125263). A literature search of major electronic databases was conducted in December 2018. Three randomized controlled trials were included in this review, and meta-analyses were performed. The proportion of discontinuing BZD anxiolytics was significantly higher in the CBT plus gradual tapering group than in the gradual tapering alone group, both in the short term (3 months after allocation; number needed to treat: 3.2, 95% confidence interval [CI]: 2.1 to 7.1; risk ratio: 1.96, 95%CI: 1.29 to 2.98, P = 0.002, three studies) and long term (6 to 12 months after allocation; number needed to treat: 2.8, 95%CI: 1.9 to 5.3; risk ratio: 2.16, 95%CI: 1.41 to 3.32, P = 0.0004, three studies). CBT may be effective for discontinuing BZD anxiolytics, both in the short term and in the long term after the allocation. Further studies with larger sample sizes are necessary to draw definitive conclusions regarding the efficacy and safety of CBT for discontinuing BZD anxiolytics in patients with anxiety disorders.

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Pharmacological Treatment of Schizophrenia: Japanese Expert Consensus

Sakurai H., Yasui-Furukori N., Suzuki T., Uchida H., Baba H., Watanabe K., Inada K., Kikuchi Y.S., Kikuchi T., Katsuki A., Kishida I., Kato M.

Pharmacopsychiatry （Pharmacopsychiatry） 54 （ 2 ） 60 - 67 2021年03月

ISSN 01763679

Introduction Conventional treatment guidelines of schizophrenia do not necessarily provide solutions on clinically important issues. Methods A total of 141 certified psychiatrists of the Japanese Society of Clinical Neuropsychopharmacology evaluated treatment options regarding 19 clinically relevant situations in the treatment of schizophrenia with a 9-point scale (1=disagree and 9=agree). Results First-line antipsychotics varied depending on predominant symptoms: risperidone (mean±standard deviation score, 7.9±1.4), olanzapine (7.5±1.6), and aripiprazole (6.9±1.9) were more likely selected for positive symptoms; aripiprazole (7.6±1.6) for negative symptoms; aripiprazole (7.3±1.9), olanzapine (7.2±1.9), and quetiapine (6.9±1.9) for depression and anxiety; and olanzapine (7.9±1.5) and risperidone (7.5±1.5) for excitement and aggression. While only aripiprazole was categorized as a first-line treatment for relapse prevention (7.6±1.0) in patients without noticeable symptoms, aripiprazole (8.0±1.6) and brexpiprazole (6.9±2.3) were categorized as such for social integration. First-line treatments in patients who are vulnerable to extrapyramidal symptoms include quetiapine (7.5±2.0) and aripiprazole (6.9±2.1). Discussion These clinical recommendations represent the expert consensus on the use of a particular antipsychotic medication for a particular situation, filling a current gap in the literature.

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Estimated model of psychotropic polypharmacy for bipolar disorder: Analysis using patients' and practitioners' parameters in the MUSUBI study

Adachi N., Azekawa T., Edagawa K., Goto E., Hongo S., Kato M., Katsumoto E., Kikuchi T., Kubota Y., Miki K., Nakagawa A., Tsuboi T., Ueda H., Watanabe K., Watanabe Y., Yasui-Furukori N., Yoshimura R.

Human Psychopharmacology （Human Psychopharmacology） 36 （ 2 ） 2021年03月

ISSN 08856222

Objective: This study aims to clarify the relevant factors influencing practitioners' methods of prescribing medications for bipolar disorder, in a nation-wide survey in Japan. Methods: The clinical records of 3130 outpatients with bipolar disorder were consecutively reviewed from 176 psychiatric outpatient clinics. Fifteen parameters, that is, five patients' including five general characteristics (sex, age, education, occupation, and social adjustment), five patients' aspects of mental functioning (onset age, comorbid mental illness, rapid-cycling, psychopathologic severity, and followed-up years), and five practitioners' characteristics (sex, age, specialist experience, clinic standing years, and location), were evaluated. The number of psychotropic drugs (mood stabilizers, antidepressants, antipsychotic drugs, anxiolytics, and hypnotics) was used as an index of pharmacotherapy. Converted data from each practitioner-unit were analyzed. Results: Seven factors (patient's social adjustment, patient's psychopathology, patient's comorbid mental disorders, patient's followed-up years, doctor's age, clinic running years, and patient's education years) were correlated to the number of psychotropic drugs. Multiple regression analysis showed that the severity of illness (poor social adjustment, and comorbid mental illness) and an intractable disease course (long followed-up years), were significantly associated with the number of psychotropic drugs. Conclusion: Our findings indicated that patient-related conditions affected psychotropic polypharmacy more strongly than did practitioner-related conditions.

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Relationship between mood episode and employment status of outpatients with bipolar disorder: Retrospective cohort study from the multicenter treatment survey for bipolar disorder in psychiatric clinics (musubi) project

Konno Y., Fujino Y., Ikenouchi A., Adachi N., Kubota Y., Azekawa T., Ueda H., Edagawa K., Katsumoto E., Goto E., Hongo S., Kato M., Tsuboi T., Yasui-Furukori N., Nakagawa A., Kikuchi T., Watanabe K., Yoshimura R.

Neuropsychiatric Disease and Treatment （Neuropsychiatric Disease and Treatment） 17 2867 - 2876 2021年

ISSN 11766328

Objective: The objective of this study was to clarify the relationship between mood episode and employment in patients with bipolar disorder to help improve their employment status. Methods: All medical records of patients with bipolar disorder who visited 176 member clinics of the Japanese Association of Neuro-Psychiatric Clinics in September-October 2016 were investigated in September-October 2017. Details of the medical care received were investigated using a survey sheet, which included employment status. Odds ratios of mood episodes for employment status were analyzed using a logistic regression model. Results: Among patients aged 60 years or less, 2292 described their occupation. On univariate analysis, odds ratios were statistically significant for depressive episode (OR=2.68 [1.50-4.78] p=0.001) and manic episode (OR=2.64 [1.07-6.47] p=0.034), whereas no significant difference was noted for mixed episode (OR=1.72 [0.69-4.33] p=0.246). On multivariate analysis, odds ratios were statistically significant for depressive episode (OR=2.16 [1.13-4.13], p=0.020) and manic episode (OR=3.55 [1.36-9.25], p=0.010), whereas no significant difference was noted for mixed episode (OR=1.83 [0.65-5.14] p=0.254). Conclusion: Employment status among these patients with bipolar disorder receiving outpatient treatment was 43.5%. Compared to remission episodes, manic and depressive episodes were associated with a higher risk of unemployment.

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How significant is the assessment of the DSM-5 'anxious distress' specifier in patients with major depressive disorder without comorbid anxiety disorders in the continuation/maintenance phase?

Otsubo T., Hokama C., Sano N., Watanabe Y., Kikuchi T., Tanaka K.

International Journal of Psychiatry in Clinical Practice （International Journal of Psychiatry in Clinical Practice） 25 （ 4 ） 385 - 392 2021年

ISSN 13651501

Objective: Anxious distress (ANXD), which is common in major depressive disorder (MDD), is associated with poor outcomes. We investigated clinical characteristics of MDD patients with the DSM-5 ANXD specifier and only mild residual symptoms without comorbid anxiety disorders in the continuation/maintenance phase. Methods: We recruited 110 outpatients with MDD without comorbid anxiety disorders. They were interviewed; the presence of the DSM-5 ANXD specifier was assessed. They completed the Quick Inventory of Depressive Symptomatology (QIDS), the Eysenck Personality Questionnaire (S-EPQ), the Temperament Evaluation of Memphis, Pisa, Paris and San Diego-Autoquestionnaire (TEMPS-A). Results: The mean QIDS total score was 9.7 ± 5.5. The DSM-5 ANXD specifier was identified in 73 patients (66.4%). A univariate analysis indicated ANXD was significantly associated with younger age; unmarried status; living alone; higher QIDS total score; higher S-EPQ neuroticism score; and higher TEMPS-A cyclothymic, depressive and irritable scores. After covariate adjustment, a multivariable linear regression analysis revealed a significant association between the QIDS total score and ANXD (three different models). Conclusion: The DSM-5 ANXD was also common among MDD patients without comorbid anxiety disorders in the continuation/maintenance phase; it was significantly associated with greater depression severity and might be related to temperament associated with bipolar disorder.Key points DSM-5 anxious distress is common among MDD patients without comorbid anxiety disorders in the continuation/maintenance phase and correlated with some of their socio-demographic and clinical characteristics. • The presence of DSM-5 anxious distress was significantly associated with greater severity of depression and might be related to temperament associated with bipolar disorder. • The evaluation of the DSM-5 anxiety distress was revealed to have some significance not only in the acute phase but also in the continuation/maintenance phase of MDD.

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Cost-effectiveness analyses of augmented cognitive behavioral therapy for pharmacotherapy-resistant depression at secondary mental health care settings

Sado M., Koreki A., Ninomiya A., Kurata C., Mitsuda D., Sato Y., Kikuchi T., Fujisawa D., Ono Y., Mimura M., Nakagawa A.

Psychiatry and Clinical Neurosciences （Psychiatry and Clinical Neurosciences） 75 （ 11 ） 341 - 350 2021年

ISSN 13231316

Aim: Pharmacotherapy is the primary treatment strategy in major depression. However, two-thirds of patients remain depressed after the initial antidepressant treatment. Augmented cognitive behavioral therapy (CBT) for pharmacotherapy-resistant depression in primary mental health care settings proved effective and cost-effective. Although we reported the clinical effectiveness of augmented CBT in secondary mental health care, its cost-effectiveness has not been evaluated. Therefore, we aimed to compare the cost-effectiveness of augmented CBT adjunctive to treatment as usual (TAU) and TAU alone for pharmacotherapy-resistant depression at secondary mental health care settings. Methods: We performed a cost-effectiveness analysis at 64 weeks, alongside a randomized controlled trial involving 80 patients who sought depression treatment at a university hospital and psychiatric hospital (one each). The cost-effectiveness was assessed by the incremental cost-effectiveness ratio (ICER) that compared the difference in costs and quality-adjusted life years, and other clinical scales, between the groups. Results: The ICERs were JPY −15 278 322 and 2 026 865 for pharmacotherapy-resistant depression for all samples and those with moderate/severe symptoms at baseline, respectively. The acceptability curve demonstrates a 0.221 and 0.701 probability of the augmented CBT being cost-effective for all samples and moderate/severe depression, respectively, at the threshold of JPY 4.57 million (GBP 30 000). The sensitivity analysis supported the robustness of our results restricting for moderate/severe depression. Conclusion: Augmented CBT for pharmacotherapy-resistant depression is not cost-effective for all samples including mild depression. In contrast, it appeared to be cost-effective for the patients currently manifesting moderate/severe symptoms under secondary mental health care.

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Clinical features related to rapid cycling and one-year euthymia in bipolar disorder patients: A multicenter treatment survey for bipolar disorder in psychiatric clinics (MUSUBI)

Kato M., Adachi N., Kubota Y., Azekawa T., Ueda H., Edagawa K., Katsumoto E., Goto E., Hongo S., Tsuboi T., Yasui-Furukori N., Yoshimura R., Nakagawa A., Kikuchi T., Kinoshita T., Watanabe Y., Miki K., Watanabe K.

Journal of Psychiatric Research （Journal of Psychiatric Research） 131 228 - 234 2020年12月

ISSN 00223956

Objective: Rapid cycling (RC) presents a risk of greater severity in bipolar disorder (BD), whereas patients with one-year euthymia (OYE) have better prognosis. The purpose of this study was to identify the clinical background and prescription characteristics of patients in the two opposing states of current RC and OYE from a large sample (N = 2609) in a multicenter treatment survey on BD in psychiatric clinics (MUSUBI). Methods: MUSIBI was a cross-sectional study wherein questionnaires, based on a retrospective medical record survey of consecutive cases of BD, were distributed to 176 outpatient clinics. The questionnaire collected information on patient background, current episode, and clinical and prescription characteristics. OYE was defined as the presence of a euthymic state for at least 12 months. Results: In this study, current RC (9.7% frequency) was significantly higher in females, had a younger age of onset, functional impairments, and a higher rate of neurodevelopmental disorder and physical comorbidity compared to non-RC patients. OYE (19.4% frequency) was associated with a lower proportion of females, older age, higher occupational status, and lower rate of suicide ideation, psychotic symptoms, personality disorder, and alcohol or substance abuse. Mood stabilizers were prescribed in ≥80% of cases, while antipsychotics were prescribed in half of the cases (more in RC and less in OYE). Antidepressant prescription rates were lower in OYE than in RC. Conclusions: RC and OYE generally show opposing characteristics, but the details of the opposite parameters are distinctive. Clinicians can help predict the progression of BD by understanding the clinical background and characteristics of these opposing clinical features.

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Real-world clinical features of and antidepressant prescribing patterns for outpatients with bipolar disorder

Tokumitsu K., Yasui-Furukori N., Adachi N., Kubota Y., Watanabe Y., Miki K., Azekawa T., Edagawa K., Katsumoto E., Hongo S., Goto E., Ueda H., Kato M., Yoshimura R., Nakagawa A., Kikuchi T., Tsuboi T., Shimoda K., Watanabe K.

BMC Psychiatry （BMC Psychiatry） 20 （ 1 ） 2020年12月

Background: Several evidence-based practice guidelines have been developed to better treat bipolar disorder. However, the articles cited in these guidelines were not sufficiently based on real-world clinical practice. Methods: The MUlticenter treatment SUrvey on BIpolar disorder in Japanese psychiatric clinics (MUSUBI) is a study conducted to accumulate evidence on the real-world practical treatment of bipolar disorder. Psychiatrists were asked to complete a questionnaire about patients with bipolar disorder by performing a retrospective medical record survey. The questionnaire included patient characteristics (age, gender, height, weight, academic background, and occupational status), comorbidities, mental status, treatment period, Global Assessment of Functioning (GAF) score, and details of pharmacological treatment. Results: Data on 2705 patients were included in this study. The proportion of patients receiving antidepressant prescriptions was 40.9%. The most commonly used antidepressant was duloxetine, and the most frequently used antidepressant class was selective serotonin reuptake inhibitors (SSRIs). Binomial logistic regression analysis and bivariate analysis revealed that the usage of antidepressants was correlated with low prescription rates for mood stabilizers, high prescription rates for anxiolytics and hypnotics, and low GAF scores. In addition, patients in a depressive state had a significantly higher rate of antidepressant prescriptions than patients with other mental states. Conclusions: Approximately 40% of patients in Japan with a diagnosis of bipolar disorder have received antidepressants. Antidepressants were most often prescribed in combination with mood stabilizers, antipsychotics or both. Patients who were prescribed antidepressants received fewer mood stabilizers, more anxiolytics, and more hypnotics than those who did not receive antidepressant prescriptions.

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Pharmacological management of bipolar disorder: Japanese expert consensus

Sakurai H., Kato M., Yasui-Furukori N., Suzuki T., Baba H., Watanabe K., Inada K., Kishida I., Sugawara Kikuchi Y., Kikuchi T., Katsuki A., Uchida H.

Bipolar Disorders （Bipolar Disorders） 22 （ 8 ） 822 - 830 2020年12月

ISSN 13985647

Objectives: The aim of this study was to develop a consensus guideline by certified experts of the Japanese Society of Clinical Neuropsychopharmacology on the psychopharmacological treatment for bipolar disorders I and II (BP-I and BP-II), in order to fill the gap in the literature and provide more concrete guidance for challenging and controversial real-world situations. Methods: Experts were asked to assess treatment options regarding 19 clinical situations of bipolar disorder with a nine-point Likert scale (one = “disagree” and nine = “agree”). According to the responses from 119 experts, the options were categorized into the first-, second-, and third-line treatments. Results: For the treatment of BP-I, lithium monotherapy was categorized as a first-line treatment for manic episodes (mean ± standard deviation score, 7.0 ± 2.2), depressive episodes (7.1 ± 2.0), and the maintenance phase (7.8 ± 1.8). Combination therapy of lithium and an atypical antipsychotic was endorsed for manic episodes (7.7 ± 1.7), depressive episodes with (7.1 ± 2.0) and without mixed features (6.9 ± 2.2), and the maintenance phase (6.9 ± 2.1). Similarly, in BP-II, lithium monotherapy was categorized as a first-line treatment for hypomanic episodes (7.3 ± 2.2), depressive episodes (7.0 ± 2.2), and the maintenance phase (7.3 ± 2.3), while combination therapy of lithium and an atypical antipsychotic was recommended for hypomanic episodes (6.9 ± 2.4).No antipsychotic monotherapy or antidepressant treatment was categorized as a first-line treatment for any type of episode. Conclusions: These recommendations reflect the current evidence and represent the experts' consensus on using lithium for the treatment of bipolar disorder. Clinicians should consider the effectiveness and adverse effects of antipsychotic and antidepressant medications for the treatment of bipolar disorder.

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