The reliability and validity of a newly developed self-rating functional scale compared with Personal and Social Performance Scale and World Health Organization Disability Assessment Schedule II.

A new self-rating functional scale (SRFS) was developed to assess the functionality of patients with schizophrenia, referred to the structure of Personal and Social Performance Scale (PSP). The main aim of this study was to evaluate the reliability and validity of the SRFS. A total of 210 patients with schizophrenia were recruited from outpatient clinics in six sites in China. Demographic information, SRFS, PSP, World Health Organization Disability Assessment Schedule II, and Positive and Negative Syndrome Scale were assessed. Spearman's correlation coefficient and path analysis were used to assess the reliability and validity of the SRFS. Cronbach's α coefficient was used to assess the internal consistency reliability. Cronbach's α was 0.83, and ranged from 0.80 to 0.82 stably, indicating that the scale was reliable in internal consistency. Spearman's correlation coefficient between split two parts was 0.68 (P<0.01), suggesting a moderate to strong split-half reliability. The standardized regression coefficients ranged from 0.48 to 0.79, indicating moderate construct validity. Spearman's correlation coefficients between SRFS and PSP, World Health Organization Disability Assessment Schedule II, and Positive and Negative Syndrome Scale are 0.59, 0.65, and 0.47 (all P<0.01), respectively, indicating moderate criteria validities. The SRFS is a reliable and valid instrument for assessing personal and social functionality in patients with schizophrenia.

Trends of Polypharmacy and Prescription Patterns of Antidepressants in Asia.

PURPOSE: Little is known regarding the trend of polypharmacy in Asia. We used data from 5 Asian countries to examine the patterns of antidepressant (AD) prescription and trends of psychotropic polypharmacy over time. METHODS: We used the cross-sectional, pharmacoepidemiological data from 2004 and 2013 REAP-AD (Research on Asian Psychotropic Prescription Patterns for Antidepressants) to examine the patterns of AD prescriptions in clinical settings in China, Japan, Korea, Singapore, and Taiwan. We compared the trend in polypharmacy (ie, concomitant use of ≥2 classes of psychotropic) among individuals receiving AD prescriptions in 2004 and 2013 using multivariable logistic regression models in different diagnostic categories. RESULTS: The proportion of patients with psychotropic polypharmacy decreased from 2004 to 2013 in all 3 diagnostic categories, including mood disorders (adjusted odds ratio [aOR], 0.44 [0.35-0.56]; P < 0.001), anxiety disorders (aOR, 0.58 [0.36-0.94]; P = 0.028), and psychotic disorders (aOR, 0.18 [0.05-0.60]; P = 0.006). Among individuals with AD prescriptions, concomitant use of anxiolytics (including sedative-hypnotics) decreased in patients with mood disorders (aOR, 0.34 [0.27-0.42]; P < 0.001) and anxiety disorders (aOR, 0.43 [0.27-0.67]; P < 0.001). In contrast, concomitant use of antipsychotics in patients with mood disorders increased (aOR, 1.43 [1.15-1.77]; P = 0.001), and concomitant use of mood stabilizers in patients with psychotic disorders also increased (aOR, 3.49 [1.50-8.14]; P = 0.004). CONCLUSIONS: This is the first study examining trends in psychotropic polypharmacy in East Asia. We found a generally decreasing trend of psychotropic polypharmacy in contrast to the increasing trend reported from Western countries. These findings could offer significant implications for health system reform or policy making.

Clinical Use of Mood Stabilizers With Antidepressants in Asia: Report From the Research on Asian Psychotropic Prescription Patterns for Antidepressants (REAP-AD) Projects in 2004 and 2013.

OBJECTIVE: As most reports concerning treatment with combinations of mood stabilizer (MS) with antidepressant (AD) drugs are based in the West, we surveyed characteristics of such cotreatment in 42 sites caring for the mentally ill in 10 Asian countries. METHODS: This cross-sectional, pharmacoepidemiologic study used 2004 and 2013 data from the REAP-AD (Research Study on Asian Psychotropic Prescription Patterns for Antidepressants) to evaluate the rates and doses of MSs given with ADs and associated factors in 4164 psychiatric patients, using standard bivariate methods followed by multivariable logistic regression modeling. RESULTS: Use of MS + AD increased by 104% (5.5% to 11.2%) between 2004 and 2013 and was much more associated with diagnosis of bipolar disorder than major depression or anxiety disorder, as well as with hospitalization > outpatient care, psychiatric > general-medical programs, and young age (all P < 0.001), but not with country, sex, or AD dose. CONCLUSIONS: The findings provide a broad picture of contemporary use of MSs with ADs in Asia, support predictions that such treatment increased in recent years, and was associated with diagnosis of bipolar disorder, treatment in inpatient and psychiatric settings, and younger age.

Bioequivalence and food effect assessment for vildagliptin/metformin fixed-dose combination tablets relative to free combination of vildagliptin and metformin in Japanese healthy subjects.

OBJECTIVE: To assess the bioequivalence of vildagliptin/metformin fixeddose combination (FDC) tablets (50/250 mg and 50/500 mg) to free combinations of vildagliptin and metformin and the effect of food on the pharmacokinetics (PK) of vildagliptin and metformin following administration of 50/500 mg FDC tablets. METHODS: Two openlabel, randomized, single-center, singledose, 2-period crossover studies were conducted in Japanese healthy male volunteers. Participants were administered vildagliptin/ metformin FDC tablets (study I: 50/250 mg, study II: 50/500 mg) or their free combinations under fasted condition. Food effect (standard Japanese breakfast: fat, 20 - 30% with ~ 600 kcal in total) was assessed during an additional period in study II (50/500 mg). PK parameters (AUC, C(max), t(max), t(1/2)) were calculated for vildagliptin and metformin. RESULTS: In both studies, vildagliptin/metformin FDC tablets were bioequivalent to their respective free combinations. Administration of FDC tablets after meals had no effect on vildagliptin PK parameters. The rate of absorption of metformin decreased when administered under fed condition, as reflected by a prolonged t(max) (3 hours in fasted state vs. 4 hours in fed state) and decrease in C(max) by 26%, however, the extent of absorption (AUC(last)) was similar to that in the fasted state. CONCLUSIONS: Vildagliptin/metformin FDC tablets were bioequivalent to their free combinations. Food decreased the C(max) of metformin by 26%, while AUC(last) was unchanged, consistent with previous reports. No food effect was observed on the C(max) or AUC(last) of vildagliptin. Thus, food had no clinically relevant effects on the PK of metformin or vildagliptin.

Individual and societal impact on earnings associated with serious mental illness in metropolitan China.

To evaluate individual-level and societal-level losses of income associated with serious mental illness in metropolitan China, a multi-stage probability survey was administered to adults aged 18-70 years in Beijing and Shanghai. We used data to estimate individual-level expected earnings from a model that included information about the respondents' education level, marital status, age, and gender. Expected earnings were compared to observed earnings among respondents with mental illness and serious disability. The result shows that the 12-month prevalence of such serious mental illness was 0.6%. Its impact on earnings was significant in the total sample and was higher for males (76% of gender-specific expected salary was lost) than for females (32%). When projected to societal level, the annual impact was estimated to be 466 million Renminbi (RMB 8.27=USD 1), less than 0.2% of the gross domestic product (GDP) of the two cities. Serious mental illness was associated with a substantial decrease in individual-level earnings, but the burden that resulted from societal-level loss of earnings was not large enough to help drive mental health policy and programs in China.

Impaired role functioning and treatment rates for mental disorders and chronic physical disorders in metropolitan China.

OBJECTIVES: To compare impairments in role functioning and treatment rate of mental disorders and chronic physical disorders in the general population of metropolitan China. METHOD: Face-to-face household interviews of 5201 people aged 18 to 70 years in Beijing and Shanghai were conducted from November 2001 to February 2002, using a multistage household probability sampling method. The World Mental Health version of the Composite International Diagnostic Interview (WMH-CIDI) was used for assessing sociodemographic characteristics, diagnoses, and treatment. The Sheehan Disability Scale (SDS) was used to measure disorder-specific role impairment. RESULTS: Respondents generally attributed greater impairment to mental disorders than to chronic physical disorders, although there were some variations among specific disorders. This general pattern was supported by within-person comparison of impairment associated with a mental disorder versus any chronic physical disorder. Depression, generalized anxiety disorder, and specific phobia were the most impairing mental disorders. Diabetes, headaches, and asthma were the most impairing physical disorders. Comorbid mental and physical disorders were associated with more severe impairment. A much lower percentage of respondents with mental disorders (3.0%) than chronic physical disorders (42.8%) received treatment in the previous 12 months. CONCLUSION: Common mental disorders were associated with greater impairment than chronic physical disorders but were markedly undertreated. They warrant prioritization in the allocation of healthcare resources in China.

Lifetime prevalence and inter-cohort variation in DSM-IV disorders in metropolitan China.

BACKGROUND: This is the first study to examine variation across cohorts in lifetime risk of DSM-IV mental disorders in metropolitan China. METHOD: Face-to-face household interviews of 2633 adults in Beijing and 2568 adults in Shanghai were conducted from November 2001 to February 2002 using a multi-stage household probability sampling method. The Chinese World Mental Health (WMH) Survey Initiative version of the WHO Composite International Diagnostic Interview (WMH-CIDI) was used for assessment. RESULTS: Lifetime prevalence of any disorder was 13.2%. Alcohol abuse (4.7%), major depressive disorder (3.5%), and specific phobia (2.6%) were the most common disorders. The median age of onset was later for mood (43 years) than anxiety (17 years) and substance use (25 years) disorders. Compared to observed lifetime prevalence, the projected lifetime risk as of age 75 years increased by 106% for major depressive disorder (7.2%), and was uniformly higher for all disorders. Relative odds of any lifetime disorder were 4.7 in the most recent cohorts (ages 18-34) compared to the eldest cohorts (ages > or =65). CONCLUSIONS: The findings of this cross-sectional study tally with the view that rapid socioeconomic changes may bring about increasing incidence of mental disorders in China. However, prospective longitudinal studies are needed to confirm if the increase is real. Because of the huge size of the Chinese population, any increase in projected lifetime risk of mental disorders represents an enormous increase in the number of affected individuals.

Twelve-month prevalence, severity, and unmet need for treatment of mental disorders in metropolitan China.

BACKGROUND: Psychiatric epidemiological surveys in China have repeatedly found much lower prevalence estimates than in most other parts of the world. METHOD: Face-to-face household interviews of 5201 subjects (2633 in Beijing and 2568 in Shanghai respectively) were conducted from November 2001 to February 2002 using a multistage household probability sampling method. A Chinese version of the World Health Organization Composite International Diagnostic Interview (CIDI) was used for assessment. RESULTS: Twelve-month prevalence of any DSM-IV mental disorder in metropolitan China is estimated to be 7.0%, with major depressive disorder (2.0%), specific phobia (1.9%), and intermittent explosive disorder (1.7%) the most common disorders. Of these, 13.9% are classified as serious, 32.6% moderate, and 53.5% mild. Only 3.4% of respondents with any disorder sought treatment within the previous 12 months. CONCLUSIONS: Although the general pattern of disorders, risk factors, and unmet need for treatment are similar to those in other countries, a low prevalence of mental disorders is found in metropolitan China. Resolving methodological problems that cause downward bias in estimates, such as stigma-related under-reporting and diagnostic incongruity with a somatopsychic mode of symptom presentation may lead to more accurate and probably higher prevalence estimates in future epidemiological studies. As a low prevalence still translates into an enormous number of people in China, measures are urgently needed to address the huge unmet need for treatment of mental disorders.