Real-world predictors of divorce among outpatients with bipolar disorder: sex differences and clinical implications.

BACKGROUND: Bipolar disorder is a mental illness characterized by recurring episodes of mania and depression and is known to cause social impairment. Additionally, it has been revealed that bipolar disorder increases the risk of divorce and loss of family member support, which can worsen the prognosis. However, there is limited evidence regarding the predictive factors of divorce among patients with bipolar disorder in real-world settings. METHODS: This study utilized an observational approach and involved psychiatrists from 176 member clinics of the Japanese Association of Neuro-Psychiatric Clinics. They were requested to conduct a retrospective review of medical records and complete a questionnaire focused on patients diagnosed with bipolar disorder. The data collection period for baseline patient characteristics spanned from September to October 2017. Next, we investigated the incidence of divorce over a 2-year period, ranging from baseline to September to October 2019. RESULTS: A total of 1071 outpatients with bipolar disorder were included in the analysis, and 2.8% (30/1071) experienced divorce during the first 2 years of observation. The incidence of divorce in this population was considerably higher than that in the general Japanese population. Binomial logistic regression analysis confirmed that a younger baseline age and lower BMI values were statistically significant predictors of divorce occurrence for all study participants. The predictors of divorce were then examined separately by sex. The results revealed that for men, a younger age at baseline and having bipolar I disorder compared to bipolar II disorder were statistically significant predictors of divorce. In contrast, for women, having a lower BMI and using anxiolytics emerged as statistically significant predictors of divorce. CONCLUSIONS: In this study, a younger baseline age and lower BMI values were statistically significant predictors of divorce in patients with bipolar disorder. Notably, the predictors of divorce varied significantly between men and women. These findings provide important insights from a family perspective regarding social support for individuals with bipolar disorder in real-world clinical settings.

Group multi-component programme based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia: a randomised controlled study (3C study).

BACKGROUND: Caregivers of people with dementia frequently experience an elevated level of psychological distress and burden. This study aimed to examine the effectiveness of a group-format multi-component programme which is based on cognitive behavioural therapy and positive psychology. METHODS: Family caregivers of dementia were allocated (1:1) to the intervention group and the wait-list control group, stratified by age (<65 years, ≥65 years) and care status (at home or in an institution). The intervention group received a six-session, 10-week, group-format programme. The primary outcome was the Hospital Anxiety Depression Scale (HADS). Secondary outcomes were the short-version of the Zarit Burden Interview (personal strain and role strain), Neuropsychiatric Inventory Questionnaire, Dementia Caregiver Positive Feeling Scale, and Self-Compassionate Reactions Inventory. The evaluations were conducted at baseline, 10 weeks (post-intervention), and 14 weeks (follow-up). RESULTS: The analyses were performed with 64 registered participants. In the whole sample, no significant effect was observed on HADS. There was medium effect on role strain (P = 0.04, partial η2  = 0.08). Positive feelings of caregiving increased after the intervention but were not maintained at follow-up. In the subgroup analysis of caregivers under 65 years of age, a statistically significant effect was observed for personal strain (P = 0.03, partial η2 = 0.16). An interaction effect was also found for the total score of positive feelings of caregiving (P < 0.05, partial η2 = 0.02) and the meaning of caregiving (P = 0.02, partial η2 = 0.10). CONCLUSIONS: This programme did not show significant improvement in depression and anxiety of caregivers of dementia; however, it reduced the burden of their role conflict (role strain) and yielded favourable short-term effects on the positive feelings and the meaning of caregiving among the participants. Also, the programme effectively reduced the personal strain of caregivers under 65 years.

Effect of age and sex on prescriptions for outpatients with bipolar disorder in the MUSUBI study: a cross­sectional study.

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.

Efficacy and Acceptability of Remote Cognitive Behavioral Therapy for Patients With Major Depressive Disorder in Japanese Clinical Settings: A Case Series.

Remote cognitive and behavioral therapy (CBT) via videoconference has been garnering attention as a means of improving access to CBT for depression, in particular during the coronavirus disease 2019 pandemic. However, there is a lack of evidence supporting its implementation in Japanese clinical settings. This case series aimed to establish preliminary evidence of whether remote CBT can be an effective therapy for major depression in Japanese clinical settings. Five patients who met the diagnostic criteria for major depressive disorder were enrolled and underwent remote CBT via videoconference and face-to-face assessment interviews. The results showed that remote CBT via videoconference improved depressive symptoms, enabling a relatively high level of patient satisfaction and working alliance. Moreover, detailed feedback from our patients showed that continuous monitoring was preferable for increasing treatment engagement. Further research is warranted to test the efficacy and acceptability of remote CBT via videoconference for treating major depression.

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

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.

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

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.

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

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.

Effectiveness of mindfulness-based cognitive therapy in patients with anxiety disorders in secondary-care settings: A randomized controlled trial.

AIM: The primary objective of this study was to examine the effectiveness of mindfulness-based cognitive therapy (MBCT) in secondary-care settings where the vast majority of the patients have already undergone pharmacotherapy but have not remitted. METHODS: Eligible participants were aged between 20 and 75 years and met the criteria for panic disorder/agoraphobia or social anxiety disorder specified in the DSM-IV. They were randomly assigned to either the MBCT group (n = 20) or the wait-list control group (n = 20). The primary outcome was the difference in mean change scores between pre- and post-intervention assessments on the State-Trait Anxiety Inventory (STAI). The outcome was analyzed using an intent-to-treat approach and a mixed-effect model repeated measurement. RESULTS: We observed significant differences in mean change scores for the STAI State Anxiety subscale (difference, -10.1; 95% confidence interval, -16.9 to -3.2; P < 0.005) and STAI Trait Anxiety subscale (difference, -11.7; 95% confidence interval, -17.0 to -6.4; P < 0.001) between the MBCT and control groups. CONCLUSION: MBCT is effective in patients with anxiety disorders in secondary-care settings where the vast majority of patients are treatment-resistant to pharmacotherapy.

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial.

BACKGROUND: Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE: This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS: A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS: We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. CONCLUSIONS: Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).

Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.

BACKGROUND: The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. METHODS/DESIGN: The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. DISCUSSION: The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. TRIAL REGISTRATION: ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).

Characteristics of female mentally disordered offenders culpable under the new legislation in Japan: A gender comparison study.

BACKGROUND: Although a substantial increase in the number of female offenders has drawn interest towards understanding their unique characteristics, few studies have investigated the characteristics of female mentally disordered offenders in Japan and none since the legislation enacted in 2005 in Japan, which provided for special services for them. AIMS: The aim of this study is to identify those characteristics of people detained under this legislation, which distinguish the women from the men and may indicate special needs among the women. METHODS: A retrospective records-based study of all patients admitted to one secure unit in the 8 years since its opening in July 2005 until a census date of 31 October 2013. RESULTS: Thirty-six (15%) of the patients were women. Marriage, mood disorders, past suicide attempts and homicide were more common among the women than the men. Six of the female offender-patients had committed filicides, of which four were infanticides. CONCLUSION: There appears to be a particularly vulnerable sub-group of women with severe mood disorders, a history of serious suicide attempts and young children at risk of harming those children. Our sample was small and from a single unit so, given the potential importance of improving understanding of who is at risk in such circumstances, extending our study nationally seems indicated.

Comparison of Initial Psychological Treatment Selections by US and Japanese Early-Career Psychiatrists for Patients with Major Depression: A Case Vignette Study.

OBJECTIVE: The authors compared early-career psychiatrists' selection of psychological treatments for patients with mild to moderate major depressive disorder (MDD) in the US and Japan. METHODS: A total of 120 early-career psychiatrists from two residency programs in the US and Japan participated in web-based surveys. The psychiatrists selected first- and second-line psychological treatments in response to two case vignettes of patients with mild and moderate MDD. RESULTS: Eighty-one psychiatrists (68%) returned the surveys, of whom 39 (48%) were American and 42 (52%) Japanese. In response to the mild MDD case, more US psychiatrists selected high-intensity psychological treatments (P < 0.001), whereas more Japanese psychiatrists selected low-intensity psychological treatments (P < 0.001). In both countries, more psychiatrists selected psychological treatment than medication. In response to the moderate MDD case, one third of the US psychiatrists selected high-intensity psychological treatments (P < 0.001), whereas half of the Japanese psychiatrists selected low-intensity psychological treatments (P = 0.010). CONCLUSIONS: Residency training, availability of psychological treatments, and cultural beliefs may shape differences in treatment selections, which in turn may impact the dissemination and implementation of psychological treatment in clinical practice across cultures.

Predicting the neural effect of switching from donepezil to galantamine based on single-photon emission computed tomography findings in patients with Alzheimer's disease.

BACKGROUND: A number of neuroimaging studies have addressed the specific effect of treatment with cholinesterase inhibitors on the frontal lobe in patients with Alzheimer's disease (AD). However, the neural effects of cholinesterase inhibitors on both apathy and executive dysfunction remain unclear. We examined whether baseline regional cerebral blood flow, as determined by using single-photon emission computed tomography, is capable of predicting changes in apathy and executive dysfunction in response to AD patients switching from donepezil to galantamine therapy. METHODS: We conducted a 24-week, prospective, open-label study of AD patients treated with galantamine who did not respond to previous treatment with donepezil. Single-photon emission computed tomography was performed at baseline, and behaviour and cognitive assessments including the Mini-Mental State Examination, the Japanese version of the Alzheimer's Disease Assessment Scale-cognitive subscale, the Frontal Assessment Battery, the Neuropsychiatry Inventory Brief Questionnaire Form, and the Dysexecutive Questionnaire were conducted at three time points (baseline and after 12 and 24 weeks of galantamine therapy). RESULTS: After galantamine therapy, the Neuropsychiatry Inventory Brief Questionnaire Form scores (apathy, irritability, and aberrant motor symptoms) and the Dysexecutive Questionnaire score improved significantly. The single-photon emission computed tomography findings showed that lower baseline regional cerebral blood flow values in several frontal areas, including the dorsolateral and ventrolateral prefrontal cortex, the anterior cingulate, and the orbitofrontal cortex, predicted greater reductions in the score for apathy (distress) on the Neuropsychiatry Inventory Brief Questionnaire Form and the Dysexecutive Questionnaire score after patients switched from donepezil to galantamine therapy. CONCLUSIONS: Our study suggests that galantamine therapy, unlike donepezil, is characterized by a dual mechanism of action that may increase acetylcholine and the nicotinic receptor-modulation effect within the frontal lobe, both of which are associated with apathy and executive dysfunction in AD patients.

[Supervision in Psychiatric Training].

Psychotherapy is an essential component of psychiatric treatment. Although appropriate training including supervision is essential to become able to conduct psychotherapy skillfully, supervision has not been performed in the training of Japanese psychiatrists. In this article, we explain how to utilize supervision in psychiatric training.

Comparison of treatment selections by Japanese and US psychiatrists for major depressive disorder: A case vignette study.

AIMS: A review of the published work on treatments for major depressive disorder suggests that there is an alarming gap between guideline recommendations and actual clinical practices worldwide. The purpose of this study was to compare early-career psychiatrists' selections of treatment for mild to moderate major depression in Japan and the USA. METHODS: The authors surveyed 120 early-career psychiatrists from two residency programs in Japan and the USA using web-based questionnaires. In response to two case vignettes of mild to moderate major depression, the subjects selected treatment modalities and first- and second-line pharmacotherapy. RESULTS: Eighty-one psychiatrists (68%) returned surveys, of whom 42 (52%) were Japanese and 39 (48%) American. Fewer Japanese subjects selected psychotherapy than Americans. The Japanese psychiatrists favored benzodiazepine monotherapy for the treatment of mild depression, whereas the American psychiatrists favored antidepressant monotherapy. For the initial treatment of moderate depression, approximately half of the Japanese selected antidepressant monotherapy, and a quarter selected benzodiazepine monotherapy, whereas the Americans unanimously selected selective serotonin reuptake inhibitors monotherapy. As a second-line strategy, the Japanese were more likely to augment medication and less likely to increase dosage for moderate depression than their American counterparts. CONCLUSIONS: Differences were found between the treatment selections of early-career psychiatrists in Japan and the USA, despite comparable guidelines and postgraduate training. The results suggest that the gap between guidelines and practice may also be shaped by physician workload, attitudes toward side-effects, and the sociocultural contexts in which clinical decisions are made.

[Adverse drug reactions of psychotropic agents: adverse drug reactions and safety monitoring of psychotropic agents].

Pharmacological treatments of psychiatric illness have been developed and many psychotropic drugs are now on the market. The body of safety information regarding psychotropic agents is so large that it is difficult for clinicians to consider all the details of possible adverse drug reactions(ADRs) in daily clinical practice. Although it is impossible to predict and prevent all occurrences of ADRs, many of them may be preventable. In this context, there is a strong need for compact manuals of diagnosis and treatment for ADRs arising from psychotropic agents that are likely to be used in daily practice. Under the auspices of the Japanese Society of Psychiatry and Neurology, a task force was convened to answer this need. This review focuses on the general considerations of ADRs with psychotropic agents, based on discussions of the task force. We also discuss the guidelines for drug safety monitoring, targeted towards specific psychiatric disorders or patients taking specific classes of drugs. Finally, we introduce the Adverse Drug Reactions Relief System in Japan.

Comparison of brexpiprazole, aripiprazole, and placebo for Japanese major depressive disorder: A systematic review and network meta-analysis.

AIM: This systematic review and frequentist network meta-analysis used random-effects models is conducted to determine whether there are differences in the efficacy, acceptability, tolerability, and safety profiles of brexpiprazole (BRE) and aripiprazole (ARI) for Japanese with major depressive disorder (MDD) who were inadequately responsive to antidepressants. METHODS: Outcome measures were scores on the Montgomery Åsberg Depression Rating Scale (primary), the Clinical Global Impression severity scale, and social functioning scale; the non-response rate; the non-remission rate; all-cause discontinuation; discontinuation due to adverse events (DAE); at least one adverse event (1AE); serious adverse event, akathisia; tremor; weight gain. RESULTS: A literature search identified three double-blind, randomized, placebo-controlled trials. These comprised one BRE study (with a 1 mg/day [BRE1] and a 2 mg/day [BRE2]) and two ARI studies (with a 3 mg/day arm and a flexible-dose arm[within the dosage range approved in Japan]) (n = 1736). Both BRE and ARI demonstrated better efficacy than the placebo. BRE but not ARI had a higher DAE than the placebo. ARI but not BRE had a higher 1AE than the placebo. BRE and ARI had a higher risk of akathisia and weight gain than the placebo. There were no significant differences between BRE and ARI for any of the outcomes. Although BRE1 had good efficacy, it carried risk of weight gain. Although BRE2 also had efficacy, it carried risks of DAE, akathisia, and weight gain. However, the risk of akathisia in BRE2 was reduced by an initial dose of 0.5 mg/day rather than 1.0 mg/day. CONCLUSIONS: Overall BRE showed similar utility to ARI and a good risk-benefit balance.

Comparison of changes in stress coping strategies between cognitive behavioral therapy and pharmacotherapy.

Background: Coping refers to conscious responses to negative circumstances, with the intention of ameliorating these situations. Few studies have compared the differences between psychotherapy and medication treatment for coping strategies for depression. In this study, we investigated the differences in coping strategies between cognitive behavioral therapy (CBT) combined with medication (CBT group) and medication alone (pharmacotherapy group) among outpatients with depression. Methods: A prospective observational study was conducted among 50 patients with major depression (24 and 26 in the CBT and pharmacotherapy groups, respectively). Stress coping strategies (Coping Inventory for Stressful Situations [CISS]) and depression severity (Beck Depression Inventory-Second Edition [BDI-II]) were assessed at baseline and 16 weeks later. Changes in the CISS and BDI-II scores in both groups were tested using repeated analysis of variance. Inverse probability weighting with propensity score analysis was applied to address potential selection bias. Results: At 16 weeks, the CBT group exhibited increased CISS task-oriented coping, distraction, and social diversion scores, which differed from those of the pharmacotherapy group. The CBT group exhibited a significantly greater reduction in depressive symptoms than the pharmacotherapy group. Limitations: This study was not a randomized controlled trial and thus may have selection bias. Conclusion: Gaining adaptive coping skills, including task-oriented coping, distraction, and social diversion skills, by combining CBT with medication may lead to greater improvement in depression symptoms. These findings suggest that clinicians should evaluate coping strategies and facilitate the acquisition of adaptive coping strategies in patients with depression to reduce their symptoms.

A cross-cultural comparison study of depression assessments conducted in Japan.

BACKGROUND: The advent of global clinical trials has necessitated the use of English-based rating instruments in diverse cultures where English is clearly not the primary language. The cross-cultural applicability of rating instruments developed in one language with only one cultural group is an important issue in both research and clinical settings where these instruments might be used. We examined the cross-cultural applicability of the Montgomery-Asberg Depression Rating Scale (MADRS) in Japan. METHODS: As part of a rater-training program for a clinical trial in Japan, we assessed inter-rater agreement using two videotaped MADRS interviews administered in Japanese and produced with English subtitles. We looked for possible interpretational variance that might have been generated by cultural differences between Japanese raters in Japan and English-speaking raters in the USA scoring the same interviews. RESULTS: The US and Japanese raters demonstrated high inter-rater agreement and no significant scoring difference on the total MADRS score. The subtitles in English did not adversely affect the overall scoring.We separately analyzed the 10 individual items from each of the two MADRS interviews used for rater training. Of the 20 items, 18 were concordant between the US and Japanese raters. In one interview, the US raters scored lassitude significantly higher (p = 0.013) and the inability to feel significantly lower (p = 0.037) than the Japanese raters, reflecting a possible interpretational difference on these items. CONCLUSION: Although developed in Europe, these findings support the general applicability of the MADRS to assess the severity of depressive symptoms in Japan. We did note significant scoring differences on 2 of the 20 individual items, suggesting a possible cultural difference. It is possible that more interviews might have revealed more interpretational differences. These findings highlight the need for cultural familiarity when assessing psychiatric patients.

[Cognitive therapy/cognitive behavior therapy for depression].

Cognitive behavior therapy (CBT) is a structured short-term therapy designed to change the patient's negatively distorted cognition. The effectiveness of cognitive therapy/cognitive behavior therapy has been increasingly recognized not only by professionals and academics but also by the public, and in April, 2010, this therapy started to be covered by the national health insurance in Japan. In this article, the author described the high-intensity and low-intensity CBT from the practical point of view.