Effect of maximal-intensity and high-intensity interval training on exercise capacity and quality of life in patients with acute myocardial infarction: a randomized controlled trial.

BACKGROUND: An increase in V̇O2max is important for acute myocardial infarction morbidity, and recurrence rate and intensity have been suggested as important factors in improving V̇O2max. AIM: The aim of this study was to compare the effects of maximal-intensity interval training (MIIT) and high-intensity interval training (HIIT) on exercise capacity and health-related Quality of Life (HRQoL) in patients with acute myocardial infarction (MI) at low and moderate cardiac risk in cardiac rehabilitation (CR). This study secondarily aimed to compare the effects of hospital-based phase II CR and usual care. DESIGN: This study is a randomized controlled trial. SETTING: Outpatient Rehabilitation Setting. POPULATION: Fifty-nine patients with acute MI were randomly assigned to the MIIT (N.=30) or HIIT (N.=29) group, and 32 to the usual care group. METHODS: Twice a week, an intervention was conducted for nine weeks in all groups. The maximum oxygen intake (V̇O2max) and MacNew Heart Disease HRQoL were evaluated before and after intervention. RESULTS: A significant interaction was observed between time and group for V̇O2max (P<0.001). The MIIT group showed greater improvement than those exhibited by the HIIT and usual care groups (P<0.05). Similarly, a significant time and group interaction was observed on the MacNew Global, Physical, and Emotional scales (P<0.05), but not on the social scale (P>0.05). CONCLUSIONS: Compared to HIIT and usual care, MIIT significantly increased the V̇O2max and was as safe as HIIT in patients with acute MI with low and moderate cardiac risk in CR. Additionally, MIIT and HIIT were superior to usual care in terms of improving the HRQoL. CLINICAL REHABILITATION IMPACT: Our results suggest that increased intensity in phase II CR could result in better outcomes in terms of V̇O2max increment in patients with acute MI and low and moderate cardiac risk in CR.

The Difference in the Quality of Life of Korean Children With Attention-Deficit/Hyperactivity Disorder Between Before and After COVID-19.

Objectives: This study aimed to compare the quality of life (QoL) of children with attention-deficit/hyperactivity disorder (ADHD) before and during coronavirus disease-2019 (COVID-19) and to examine how their QoL is affected by emotional and environmental factors during COVID-19. Methods: Participants in the pre-COVID-19 (n=43) and COVID-19 (n=36) groups were recruited from the same university hospital. The Pediatric Quality of Life Inventory (PedsQL) 4.0 Child Self-report, the Children's Depression Inventory (CDI), the Revised Children's Manifest Anxiety Scale (RCMAS), the PedsQL 4.0 Parent Proxy Report, and the Conners' Parent Rating Scale (CPRS) were employed. Independent t-tests, Pearson's correlation analysis, and multiple regression analysis were conducted. Results: Caregivers assessed the children's QoL more negatively than the children themselves in both groups. Children with ADHD evaluated their physical function more negatively and anxiety was significantly higher in the COVID-19 group. In the COVID-19 group, the PedsQL child self-report was significantly predicted by the CPRS, the CDI, and environmental factors (i.e., relation to child and monthly household income). Conclusion: Children with ADHD in the COVID-19 group had a numerically lower QoL and significantly higher anxiety. To improve QoL, it is important to deal with not only depression but also ADHD symptoms and environmental factors.

Development of Korean Version of PTSD Checklist for DSM-5 (K-PCL-5) and the Short Form (K-PCL-5-S).

OBJECTIVE: This study presents the reliability and validity of the Korean version of the post-traumatic stress disorder (PTSD) checklist for the Diagnostic and Statistical Manual for Mental Disorders-fifth edition (DSM-5) (K-PCL-5) and the short form (K-PCL-5-S). METHODS: Seventy-one subjects with PTSD, 74 subjects with mood or anxiety disorders, and 99 healthy controls were enrolled. The Korean version of the Structured Clinical Interview for DSM-5-research version was used to confirm the presence of PTSD. The Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Impact of Event Scale-Revised (IES-R), and Spielberger State Trait Anxiety Inventory (STAI) were used to evaluate the concurrent validity of the K-PCL-5 and K-PCL-5-S. RESULTS: It presented good internal consistency (Cronbach's α=0.93) and test-retest reliability (r=0.90). The K-PCL-5 and K-PCL-5-S were highly correlated with the BDI-II, BAI, IES-R, STAI-S, and STAI-T. The suggested cutoff score for PTSD was 33 for the K-PCL-5 with a sensitivity of 88.51 and specificity of 89.09, and 6 for the K-PCL-5-S with a sensitivity of 91.95 and specificity of 89.09. The data were best explained with a one-factor model. CONCLUSION: These results demonstrated the good reliability and validity of the K-PCL-5 and K-PCL-5-S, and their suitability as simple tools for PTSD assessment.

The longitudinal effects of chronotype on chemotherapy-induced nausea and vomiting in patients with breast cancer receiving neoadjuvant chemotherapy.

OBJECTIVE: The object of this longitudinal cohort study was to investigate whether chronotype affects the incidence of chemotherapy-induced nausea and vomiting (CINV) among patients with breast cancer. METHODS: The study included a total of 203 breast cancer patients who received neoadjuvant chemotherapy using a regimen of doxorubicin and cyclophosphamide with high emetogenicity. Patients received four cycles of chemotherapy in approximately three months. Patients completed questionnaires including the Munich Chronotype Questionnaire (MCTQ) before the first chemotherapy and the Multinational Association of Supportive Care in Cancer Antiemesis Tool (MAT) after each of the four chemotherapy sessions. To confirm the effect of chronotype on CINV during the four cycles, we performed statistical analyses using a generalized estimating equation (GEE). RESULTS: CINV occurred in 108 (53.2%), 112 (55.2%), 102 (50.3%), and 62 (30.5%) patients during four cycles of treatment. In the GEE approach, late and early chronotypes (vs. intermediate chronotype) were associated with an increased risk of CINV (late chronotype: odds ratio [OR], 2.06; 95% confidence interval [CI], 1.41-2.99; p < 0.001, early chronotype: OR, 1.84; CI, 1.25-2.73; p = 0.002), which remained significant even after adjusting for age, BMI, antiemetic treatment, history of nausea and vomiting, anxiety, and sleep quality. CONCLUSION: Chronotype affected CINV across the four cycles of neoadjuvant chemotherapy in patients with breast cancer, suggesting the need to consider chronotype in predicting and managing CINV.

Psychiatric symptoms mediate the effect of resilience on health-related quality of life in patients with breast cancer: Longitudinal examination.

OBJECTIVE: Patients with breast cancer receiving neoadjuvant chemotherapy are at increased risk of poor health-related quality of life (HRQOL). This study examined clinical caseness on depression and anxiety mediate the relationship between resilience and HRQOL in patients with breast cancer. METHODS: A total of 193 patients with breast cancer undergoing neoadjuvant chemotherapy completed questionnaires including the Connor-Davidson Resilience Scale, Hospital Anxiety and Depression Scale (HADS), and Functional Assessment of Cancer Therapy-Breast before the first session (T0), before the start of the last session (T1), and 6 months after the end (T2) of chemotherapy. Mediation analyses using a bootstrapping method was performed. RESULTS: The indirect effect (IE) through T1 depression was significant (IE through depression = 0.043, 95% confidence interval [CI] [0.002-0.090]), while IE through T1 anxiety was not significant (IE through anxiety = 0.037, 95% CI [-0.010-0.097]) in the association between T0 resilience and T2 HRQOL. CONCLUSIONS: Clinical caseness on HADS depression subscale during chemotherapy was a mediating factor of the relationship between resilience before chemotherapy and HRQOL after chemotherapy in patients with breast cancer receiving neoadjuvant chemotherapy. Depression during chemotherapy in patients with breast cancer may be a target symptom of screening and intervention to maintain the HRQOL after chemotherapy. Also, patients with low resilience are more likely to develop depression during chemotherapy, and clinicians should carefully monitor whether depression occurs in these patients with low resilience.

The Effect of Bright Light Therapy on Sleep and Quality of Life in Patients With Poststroke Insomnia.

OBJECTIVE: Poststroke insomnia is common and negatively affects stroke recovery. The objective of this study was to determine the effectiveness of bright light therapy for mild-to-moderate stroke patients with insomnia. METHODS: This study was randomized, double blind, and placebo controlled. A 2-week trial was conducted on patients with mild-to-moderate stroke who had poststroke insomnia. Only patients who had experienced a first episode of stroke were enrolled in this study. Sleep parameters were measured using the Actiwatch Spectrum Pro for 7 days before and after light therapy. The instrument specifically collected data concerning sleep, mood state, fatigue, and subjective quality of life. Participants with poststroke insomnia received bright light therapy (10,000 lux) or placebo therapy for 30 minutes in the early morning. A total of 112 eligible participants entered the study, but only 56 patients were randomized to treatment (27 to bright light therapy and 29 to placebo therapy). RESULTS: Results from analysis of variance showed that the mean change of sleep latency (F(1,55) =4.793, p = .033) and sleep efficiency (F(1,55) = 5.625, p = .022) were significantly superior in bright light therapy over placebo. Bright light therapy resulted in significant improvements in daytime sleepiness, fatigue, mood, and quality of life in study participants (p < .05). CONCLUSIONS: Bright light therapy is a nonpharmacological treatment of early, poststroke insomnia in patients who had a mild to moderate stroke. In addition, bright light therapy is effective for the treatment of daytime sleepiness, fatigue, and depression and for improving quality of life in patients with poststroke insomnia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04721574.

Development of Korean Version Burnout Syndrome Scale (KBOSS) Using WHO's Definition of Burnout Syndrome.

BACKGROUND: Burnout syndrome (BOS) is defined by the World Health Organization (WHO) as a syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed. This study aims to create the Korean version burnout syndrome scale (KBOSS) that conforms to WHO's definition of BOS and present the cut-off points for screening. METHODS: We developed the KBOSS based on WHO's definition of BOS. An online survey was conducted through a specialized online research company. We recruited 444 workers for this research. The validity of the KBOSS was assessed using factor analysis and Pearson's correlation. The KBOSS reliability was assessed using Cronbach's alpha coefficient. The cut-off points for each of the three dimensions were derived using the upper quartile score. RESULTS: The validity and reliability of the KBOSS were good. Regarding reliability, the scale's overall Cronbach's alpha was 0.813. Cronbach's alpha of each three-dimension was as follows: exhaustion, 0.916; cynicism, 0.865; and professional inefficacy, 0.819. The cut-off points of BOS three dimensions are exhaustion ≧ 21; cynicism ≧ 18; and inefficacy ≧ 15. CONCLUSION: The developed questionnaire (KBOSS) can be a useful tool for screening of BOS.

Effects of Virtual Reality-Based Cognitive Training in the Elderly with and without Mild Cognitive Impairment.

OBJECTIVE: This study aimed to introduce a 4-week long fully immersive virtual reality-based cognitive training (VRCT) program that could be applied for both a cognitively normal elderly population and patients with mild cognitive impairment (MCI). In addition, we attempted to investigate the neuropsychological effects of the VRCT program in each group. METHODS: A total of 56 participants, 31 in the MCI group and 25 in the cognitively normal elderly group, underwent eight sessions of VRCT for 4 weeks. In order to evaluate the effects of the VRCT, the Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet was administered before and after the program. The program' s safety was assessed using a simulator sickness questionnaire (SSQ), and availability was assessed using the presence questionnaire. RESULTS: After the eighth session of the VRCT program, cognitive improvement was observed in the ability to learn new information, visuospatial constructional ability, and frontal lobe function in both groups. At the baseline evaluation, based on the SSQ, the MCI group complained of disorientation and nausea significantly more than the cognitively normal elderly group did. However, both groups showed a reduction in discomfort as the VRCT program progressed. CONCLUSION: We conclude that our VRCT program helps improve cognition in both the MCI group and cognitively normal elderly group. Therefore, the VRCT is expected to help improve cognitive function in elderly populations with and without MCI.

Significant Domains of Life Satisfaction That Affect Suicidal Behavior in Adolescents.

OBJECTIVES: Adolescent suicide is a serious national issue in Korea. Recently, life satisfaction has been recognized as a major factor related to this issue. The main purpose of this study was to identify the domains of life satisfaction that affect suicidal behavior in adolescence. METHODS: Data were collected from eight middle schools in Incheon, Korea. A total of 1297 students answered questions regarding their demographic characteristics, happiness, self-related life satisfaction domains (appearance, leisure time, physical health, and mental health), depressive symptoms, and suicidal behavior. RESULTS: In the Spearman correlation analysis, female sex, perceived socioeconomic status (SES), happiness, and all four self-related satisfaction scores showed significant correlations with depression and suicidality. Multivariate regression analysis suggested that suicidality was significantly affected by perceived SES, satisfaction with appearance, mental health satisfaction, and depression. Finally, depression was identified as a partial mediator of the association between mental health satisfaction and suicidality, and a complete mediator of the association between female sex and suicidality. CONCLUSION: Perceived SES, satisfaction with appearance, and mental health satisfaction significantly affected students' suicidality, with or without the effect of depression. Health authorities, educators, and family members must be aware of this to identify adolescents at suicide risk earlier.

Cognitive reserve and the effects of virtual reality-based cognitive training on elderly individuals with mild cognitive impairment and normal cognition.

BACKGROUND: Cognitive reserve (CR) is a concept proposed to account for discrepancies between the extent of brain pathology and clinical manifestations of that pathology. This study aimed to explore the associations between CR and the effects of cognitive training using fully immersive virtual reality (VR). METHODS: A total of 44 older adults (22 cognitively normal, 22 with mild cognitive impairment) underwent eight cognitive training sessions using VR for a period of 4 weeks. CR was assessed using the Cognitive Reserve Index questionnaire (CRIq). To evaluate baseline cognitive function and the effects of VR training, the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neuropsychological battery was administered to all participants before and after the training. RESULTS: Greater improvement in the total CERAD score was seen for cognitively normal participants with higher versus lower scores on the Education subdomain of the CRIq. Among patients with mild cognitive impairment, none of the CRIq subdomain scores (Education, Working Activity, Leisure Time) were related to a change in CERAD total scores. The CRIq total score did not predict the improvement of global cognition in either group. CONCLUSIONS: This study revealed different impacts of CR on cognitive training according to the participants' cognitive status. It also suggests that employing three proxies of CR rather than using a composite score would provide a more accurate understanding of one's CR.

Variables Affecting Attitudes Toward Suicide Among the Adolescent Population.

Past research has supported the positive association between prosuicide attitudes and suicidal behavior. The aim of the present study was to determine the factor structure of adolescents' attitudes toward suicide and to explore correlates associated with their attitudes. A questionnaire was distributed to 1292 adolescents at eight middle schools to assess their demographic information, clinical variables, and attitudes toward suicide. After factor analysis, we reached a four-factor solution of the attitudes toward suicide. Significantly more females, nonreligious adolescents, those with a lower socioeconomic status, those with higher levels of depressive symptoms, and those with a history of suicidal ideation/plans had more understanding attitudes toward suicide. Depressive adolescents were also more permissive and believed that suicides were unpreventable and that loneliness led to suicide. In conclusion, adolescents' attitudes toward suicide were significantly associated with not only various sociodemographic correlates but also the severity of depressive symptoms and their own experiences of suicidality.

Association between Perceived Parenting Style and Adolescents' Attitudes toward Suicide.

OBJECTIVES: Adolescent suicide, a major cause of adolescent death, is affected by various factors, including attitudes toward suicide. This study investigated the association between parenting style and adolescents' attitudes toward suicide and the mediating role of attitude toward suicide between parenting style and suicidal ideation. METHODS: We surveyed 1,071 adolescents from eight middle schools in Incheon, Korea. The survey included sociodemographic information, attitudes toward suicide, perception of parenting style, depression severity, and suicidality. RESULTS: Students in the authoritarian parenting group had a more permissive attitude toward suicide compared with the democratic and permissive parenting groups. These students considered that suicide is justified in certain situations and that choosing suicide is an individual's right. They also had a negative attitude toward talking about suicide or intervening in others' suicide. This association remained statistically significant after adjusting for the impact of confounding factors that could affect attitudes toward suicide, except for suicidal processes and preparedness to prevent suicide. In the mediation analysis, we observed that some factors of the attitudes toward suicide mediated between authoritarian parenting attitudes and suicidal ideation, namely, suicide as a right, preventability, suicide as normal/common, preparedness to prevent suicide, and resignation. CONCLUSION: This study revealed the significant impact of parenting style on children's attitudes toward suicide. Educating parents about the appropriate parenting attitudes-sympathetic and rational-can help prevent youth suicide.

Phenomenological examinations of delirium in advanced cancer patients: exploratory structural equation modelling and latent profile analysis.

BACKGROUND: This study examined phenomenological manifestations of delirium in advanced cancer patients by examining the factor structure of the Delirium Rating Scale-Revised-98 (DRS-R-98) and profiles of delirium symptoms. METHODS: Ninety-three patients with advanced cancer admitted to inpatient palliative care units in South Korea were examined by psychiatrists using the DRS-R-98 and the Confusion Assessment Method (CAM). The factor structure of the DRS-R-98 was examined by exploratory structural equation modelling analysis (ESEM) and profiles of delirium were examined by latent profile analysis (LPA). RESULTS: CAM-defined delirium was present in 66.6% (n = 62) of patients. Results from the ESEM analysis confirmed applicability of the core and noncore symptom factors of the DRS-R-98 to advanced cancer patients. LPA identified three distinct profiles of delirium characterizing the overall severity of delirium and its core and noncore symptoms. Class 1 (n = 55, 59.1%) showed low levels of all delirium symptoms. Class 2 (n = 17, 18.3%) showed high levels of core symptoms only, whereas Class 3 (n = 21, 22.6%) showed high levels of both core and noncore symptoms except motor retardation. CONCLUSIONS: Clinical care for delirium in advanced cancer patients may benefit from consideration of the core and noncore symptom factor structure and the three distinct phenomenological profiles of delirium observed in the present study.

Prevalence and comorbidities of adult adhd in male military conscripts in korea: Results of an epidemiological survey of mental health in korean military service.

We assessed the prevalence/comorbidities of attention deficit hyperactivity disorder (ADHD) in Korean servicemen using the Epidemiological Survey of Mental Health in Military Service in Korea. A total of 3,441 participants were assessed for adult ADHD, depression, social anxiety, generalized anxiety, somatization, insomnia, suicidality, cigarette dependence, and alcohol dependence using a self-report scale. Participants were also asked to rank their perception of their career prospects, health status, and quality of life on a Likert scale. Participants were classified as ADHD according to the WHO A-ADHD self-report scale. Firth multiple logistic regression and Cochran-Armitage trend tests were used to identify the risks of comorbidities and trends of self-perception between the two groups. ADHD (prevalence: 2.8%) was significantly associated with social anxiety (OR, 40.52; 95% CI 25.14-65.74), generalized anxiety (OR, 28.21; 95% CI 17.37-45.69), depression (OR, 16.36; 95% CI 10.50-25.52), somatization (OR, 14.47; 95% CI 9.21-22.76), suicidality (OR, 11.03; 95% CI 6.67-17.86), and insomnia (OR, 5.92; 95% CI 3.68-9.35). Servicemen with ADHD had negative perceptions (p <0.001) of their career prospects, health status, and quality of life compared to servicemen without ADHD. It is essential to revise the enlistment criteria for individuals with ADHD or to develop management programs for servicemen with ADHD.

Relationship between subjective memory complaint and executive function in a community sample of South Korean elderly.

AIM: The aim of this study was to investigate the association between subjective memory complaint (SMC) and executive function in a community sample of South Korean elderly. METHOD: Data for 1442 non-cognitive impaired elderly individuals aged 65 and over were selected from a nationwide dementia epidemiological study conducted in South Korea. Global cognitive function was assessed by the Korean version of the Mini-Mental State Examination (MMSE-KC). The registration and recall subscales of the MMSE were used for evaluating memory function. Executive function was measured by using the Initiation/Perseveration (IP) subscale of the Korean dementia rating scale (K-DRS). RESULTS: Of the 1442 participants, 1088 were in the normal control group and 354 were in the SMC group. In the SMC group, compared to the normal control group, the proportion of depression was significantly higher, total MMSE scores, delayed recall score and total IP scores were significantly lower, and the mean scores of complex/simple verbal IP, alternating movements, and graphomotor design were lower. In the unadjusted linear regression model, the SMC significantly associated with a lower score of total MMSE-KC, MMSE delayed recall, K-DRS IP, complex/simple verbal IP, alternating movements and graphomotor design. After adjusting for age, gender, education, marital status, alcohol consumption, smoking behaviour, and depression, the SMC were significantly associated with lower total MMSE score, MMSE delayed recall, K-DRS IP, and K-DRS complex/simple verbal IP. CONCLUSION: In this population-based sample, individuals with SMC had evidence of lower performance on global cognition, memory function, and executive function, especially verbal fluency, after adjusting for demographic variables and depression.

Important Consideration in Choosing Antipsychotics in the Treatment of Patients with 22q11.2 Deletion Syndrome: Risk of Convulsion.

The prevalence of epilepsy and psychosis in 22q11.2 deletion syndrome (22q11.2DS) is higher than in the general population. Recent study on adults with 22q11.2DS reported that the most common trigger for provoked seizures was the use of antipsychotics and antidepressants. In this paper, blonaserin was used because aripiprazole, quetiapine, paliperidone were not effective. The patient had convulsion on the fourth day of taking blonaserin. Neurological and cardiac examination was carried out, and lamotrigine was added at the advice of neurologist. Than the patient didn't have any convulsions and the symptoms gradually improved. When treating patients with 22q11.2DS, the medicine should be chosen carefully, and the patient should be observed closely, paying attention to the possibility of convulsions.

The effect of perceived social support on chemotherapy-related symptoms in patients with breast cancer: A prospective observational study.

OBJECTIVE: Few studies have examined the effect of perceived social support (PSS) on chemotherapy-related symptoms (CRS). This study examined the effect of PSS on CRS in 184 patients with breast cancer. METHODS: Participants were consecutively enrolled from a tertiary general hospital in Seoul, South Korea. CRS were assessed eight times, from before the first neoadjuvant chemotherapy to six months after the end of neoadjuvant chemotherapy, with the MD Anderson Symptom Inventory. PSS was evaluated once, before the first neoadjuvant chemotherapy session, using the Multidimensional Scale of Perceived Social Support (MSPSS). Two groups were formed based on MSPSS scores: the low PSS group (n = 62) and the moderate-to-high PSS group (n = 122). Linear mixed model analyses were used to compare the change in CRS severity between the two groups during chemotherapy. RESULTS: Results indicated a significant group-by-time (low PSS or moderate-to-high PSS; 8 periods of chemotherapy) interaction for pain (p = .005), nausea (p = .033), insomnia (p < .001), distress (p = .003), dyspnea (p = .014), memory loss (p = .021), vomiting (p = .016), and numbness (p = .008) in which the moderate-to-high PSS group showed significantly lower levels of increase in those symptoms during chemotherapy. Moreover, the effect of PSS on CRS differed depending on the sources of PSS. CONCLUSION: Patients with moderate-to-high PSS experience less severe CRS compared with patients with low PSS during chemotherapy. The current findings indicate the potential benefits of providing social support in the management of CRS.

Low-dose Quetiapine-induced Syndrome of Inappropriate Antidiuretic Hormone in a Patient with Traumatic Brain Syndrome.

Syndrome of inappropriate antidiuretic hormone secretion (SIADH) is characterized by hyponatremia, low serum osmolality, and clinical euvolemia in the absence of diuretic medication. And the causes of SIADH are various, antipsychotic agents and traumatic brain injury (TBI) are well known. Quetiapine is often chosen to manage the maladaptive behavior of patients with post-TBI. Although a previous study reported that quetiapine doses ranging from 25 to 300 mg were effective and tolerable, the symptoms of the patient might be aggravated. The symptoms of TBI such as nausea, malaise, headache, lethargy, and mild cognitive deficits are similar to those of SIADH. So the differentiation between SIADH and TBI may be difficult. This paper reports a case of SIADH in a patient with a TBI after using a small dose of 25 to 50 mg quetiapine.

Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study.

BACKGROUND: Blonanserin is a second-generation antipsychotic used for the treatment of schizophrenia. This study determined the efficacy, safety and pharmacokinetics of a blonanserin transdermal patch in patients with acutely exacerbated schizophrenia. METHODS: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs). RESULTS: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval [CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p < 0.001). Blonanserin was well tolerated; the most common TEAEs reported were application-site erythema and pruritus, akathisia, tremor, and insomnia. CONCLUSIONS: Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability.