Psychiatric pharmaceutical care service across Malaysian hospitals: results from a cross-sectional study.

BACKGROUND: Psychiatric pharmaceutical care is the provision of pharmaceutical care services to patients with psychiatric related illnesses or disorders. Several studies have demonstrated the positive influence psychiatric pharmaceutical care on patients' clinical, humanistic and economic outcomes. This study aimed to examine the extent of psychiatric pharmaceutical care practice in a convenience sample of Malaysian government hospitals and the barriers to the provision of these services. METHODS: An anonymous cross-sectional survey of registered pharmacists working at a convenience sample of government hospitals in Malaysia was undertaken from September 2019 to June 2020. RESULTS: Pharmacists frequently ensured the appropriateness of the dose (55%), dosage form (47%) and dosing schedule (48%) of the dispensed medications. Most pharmacists infrequently worked with patients and healthcare professionals to develop a pharmacotherapeutic regimen and a corresponding monitoring plan (28%). There was no statistically significant difference in the provision of pharmaceutical care services with respect to gender, age, years of practice, and professional board certification. However, the services offered were influenced by the respondent's education and pharmacy setting. The obstacles perceived by pharmacists included lack of time (89%), shortage of pharmacy staff (87%), the patients' inability to comprehend medical information (85%), insufficient demand and acceptance by patients (82%), the lack of official policies and standardised practice protocols (78%), inaccessibility to the patients' medical records (77%) and the lack of structured communication channels between pharmacists and physicians (75%), the pharmacists lack of knowledge/skills and confidence (78%) and insufficient recognition from physicians to the pharmacists' skills (76%). CONCLUSIONS: This is the first study to explore the extent and barriers of psychiatric pharmaceutical care in Malaysian hospitals; it highlighted the need for mobilising pharmacists to expand these services.

A comparison of sexual desire in opiate-dependent men receiving methadone and buprenorphine maintenance treatment.

BACKGROUND: Methadone is an effective therapy for opiate dependence. However, one of the commonest side effects is sexual dysfunction among male patients. Buprenorphine is an alternative to methadone. This study aimed to compare sexual desire among opiate-dependent male patients on buprenorphine (BMT) and methadone maintenance therapy (MMT). METHODS: This cross-sectional study involved 126 male opiate-dependent patient who were tested for total testosterone (TT) and prolactin levels, and were interviewed and completed the Sexual Desire Inventory-2 (SDI-2), Malay language of International Index of Erectile Function (Mal-IIEF-15) and the Malay version of the self-rated Montgomery-Asberg Depression Rating Scale (MADRS-BM) questionnaires. RESULTS: There were 95 (75.4%) patients on MMT and 31 (24.6%) on BMT. Patients on MMT scored significantly lower in the sexual desire domain (Mal-IIEF-15 scores) (p < 0.01), dyadic sexual desire (p = 0.04) and TT plasma level (p < 0.01) when compared to BMT group after controlling all the confounders. CONCLUSIONS: Patients on MMT are associated with lower sexual desire when compared with patients on BMT. Smoking may further lower testosterone and, hence, sexual desire in those already on methadone.

Plasma Testosterone and Sexual Function in Southeast Asian Men Receiving Methadone and Buprenorphine Maintenance Treatment.

BACKGROUND: Methadone has been recognized as an effective maintenance treatment for opioid dependence. However, its use is associated with several complications, including sexual dysfunction in men. AIM: To assess plasma testosterone and sexual function in Southeast Asian men on methadone maintenance treatment (MMT) or buprenorphine maintenance treatment (BMT). METHODS: 76 sexually active men on MMT (mean age = 43.30 ± 10.32 years) and 31 men on BMT (mean age = 41.87 ± 9.76 years) from a Southeast Asian community were evaluated using plasma total testosterone (TT) and prolactin levels, body mass index, social demographics, substance use measures, and depression severity scale. OUTCOMES: Prevalence and associated factors of TT level lower than the reference range in men on MMT or BMT. RESULTS: More than 1 third of men (40.8%, n = 31) on MMT had TT levels lower than the reference range, whereas 1 fourth of men (22.6%, n = 7) on BMT did. At univariate analysis, MMT vs BMT (ß = 0.298, adjusted R2 = 0.08, P = .02) and body mass index (ß = -0.23, adjusted R2 = 0.12, P = .02) were associated with changes in TT after stepwise regression. There were no significant associations with age; Opiate Treatment Index Q scores for alcohol, heroin, stimulant, tobacco, or cannabis use and social functioning domain; education levels; hepatitis C status; and severity of depression. Prolactin level did not differ between the MMT and BMT groups. CLINICAL IMPLICATIONS: The sex hormonal assay should be used regularly to check men on MMT. STRENGTHS AND LIMITATIONS: This is the first study conducted in the Southeast Asian community. Our study was limited by the lack of a healthy group as the reference for serum levels of testosterone and prolactin. CONCLUSIONS: The findings showed that plasma testosterone levels are lower in MMT than in BMT users. Hence, men who are receiving MMT should be screened for hypogonadism routinely in the clinical setting. Yee A, Loh HS, Danaee M, et al. Plasma Testosterone and Sexual Function in Southeast Asian Men Receiving Methadone and Buprenorphine Maintenance Treatment. J Sex Med 2018;15:159-166.

Clinical and socio-demographic correlates of anxious distress in Asian outpatients with major depressive disorder.

BACKGROUND: Anxious distress in major depressive disorder (MDD) is common and associated with poor outcomes and management difficulties. AIMS: This post hoc analysis aimed to examine the socio-demographic and clinical correlates of anxiety distress in Asian outpatients with MDD. METHODS: Instead of two out of five specifiers defined by the Diagnostic and Statistical Manual Version-5, anxious distress defined in this study was operationalized as the presence of at least two out of four proxy items drawn from the 90-item Symptom Checklist, Revised (SCL-90-R). Other measures included the Montgomery-Asberg Depression Rating Scale (MADRS), the Fatigue Severity Scale, the Sheehan Disability Scale and the Multidimensional Scale of Perceived Social Support. RESULTS: The data of 496 patients with MDD were included. Anxious distress was found in 371 participants (74.8%). The binary logistic regression analysis found that anxious distress was independently and significantly correlated with working status, higher MADRS scores, severe insomnia and functional impairment. CONCLUSIONS: Three-fourths of Asian patients with MDD in tertiary care settings may have DSM-5 anxious distress of at least moderate distress. Its prevalence may vary among working groups. The specifier was associated with greater depressive symptom severity, severe insomnia and functional impairment.

Anxiety and Depression in Cancer Patients: The Association with Religiosity and Religious Coping.

There is a lack of studies looking into religiosity and religious coping in cancer patient. In this cross-sectional study, we examined the religiosity using Duke University Religion Index, religious coping using Brief Religious Coping Scale, anxiety and depression based on Hospital Anxiety and Depression Scale among 200 cancer patients. The association between religiosity and religious coping with anxiety and depression was studied. The findings showed that subjects with anxiety or depression used more negative religious coping and had lower non-organization religiosity. Hence, measurements in reducing negative religious coping and encouraging religious activities could help to reduce psychological distress in cancer patients.

Psychotherapy for cancer patients.

Objective Psychotherapy is a common non-pharmacological approach to help cancer patients in their psychological distress. The benefit of psychotherapies was documented, but the types of psychotherapies proposed are varied. Given that the previous literature review was a decade ago and no quantitative analysis was done on this topic, we again critically and systematically reviewed all published trials on psychotherapy in cancer patients. Method We identified 17 clinical trials on six types of psychotherapy for cancer patients by searching PubMed and EMBASE. Result There were four trials involved adjunct psychological therapy which were included in quantitative analysis. Each trial demonstrated that psychotherapy improved the quality of life and coping in cancer patients. There was also a reduction in distress, anxiety, and depression after a psychological intervention. However, the number and quality of clinical trials for each type of psychotherapy were poor. The meta-analysis of the four trials involved adjunct psychological therapy showed no significant change in depression, with only significant short-term improvement in anxiety but not up to a year-the standardized mean differences were -0.37 (95% confidence interval (CI) = -0.57, -0.16) at 2 months, -0.21 (95% CI = -0.42, -0.01) at 4 months, and 0.03 (95 % CI = -0.19, 0.24) at 12 months. Conclusion The evidence on the efficacy of psychotherapy in cancer patients is unsatisfactory. There is a need for more rigorous and well-designed clinical trials on this topic.

Anxiety, depression, perceived social support and quality of life in Malaysian breast cancer patients: a 1-year prospective study.

BACKGROUND: Depression and anxiety are common psychiatric morbidity among breast cancer patient. There is a lack of study examining the correlation between depression, anxiety and quality of life (QoL) with perceived social support (PSS) among breast cancer patients. This study aims to study the level of depression, anxiety, QoL and PSS among Malaysian breast cancer women over a period of 12 months and their associations at baseline, 6 and 12 months. METHODS: It is a 12 months prospective cohort study. Two hundred and twenty one female patients were included in the study. They were assessed at the time of diagnosis, 6 months and 12 month using Hospital Anxiety and Depression Scale (HADS), Quality-of-Life Questionnaire (QLQ-C30), Version 3.0 of the EORTC Study Group and Multidimensional Scale of Perceived Social Support (MSPSS). The information of age, ethnicity, types of treatment, and staging of cancer were collected. RESULTS: The HADS anxiety and depression subscales scores of the subjects were relatively low. The level of anxiety reduced significantly at 6 and 12 months (Baseline - 6 months, p = 0.002; Baseline - 12 months, p < 0.001). There were no changes in the level of depression over the study period. The global status of QoL and MSPSS scores were relatively high. Correlation between the global status of QoL and MSPSS for the study subjects was positive (Spearman's rho = 0.31-0.36). Global status of QoL and MSPSS scores were negatively correlated with anxiety and depression. CONCLUSION: Malaysian breast cancer women had relatively better QoL with lower level of anxiety and depression. Perceived social support was an important factor for better QoL and low level of psychological distress. It reflects the importance of attention on activities that enhance and maintain the social support system for breast cancer patients.

Anhedonia in depressed patients on treatment with selective serotonin reuptake inhibitor anti-depressant--A two-centered study in Malaysia.

OBJECTIVE: Anhedonia is the reduced ability to experience pleasure. It is a core symptom of depression and is particularly difficult to treat. This study aims to compare the level of anhedonia between depressed patients on anti-depressants and healthy subjects. METHOD: A total of 111 depressed patients on selective serotonin reuptake inhibitor (SSRI) and 82 healthy subjects were recruited from the outpatient psychiatric services at two major general hospitals in a cross-sectional study. Subjects were assessed using the Mini International Neuropsychiatric Interview 5.0.0 or MINI, Beck's Depression Index (BDI), and Snaith-Hamilton Pleasure Scale (SHAPS). Relevant personal and sociodemographic information were also collected. RESULTS: There was a significant association between educational level and SHAPS-M scores (P < 0.01) among the participants. Most items in the SHAPS scores were significantly different (P < 0.01) in the depressed subjects treated with anti-depressant compared with the healthy subjects, after adjusting the confounding factors, BDI score, and educational level. CONCLUSION: Anhedonia often persists in depressed patients despite on SSRI anti-depressant treatment.

The risk and associated factors of methamphetamine psychosis in methamphetamine-dependent patients in Malaysia.

OBJECTIVE: The objective of this study was to determine the risk of lifetime and current methamphetamine-induced psychosis in patients with methamphetamine dependence. The association between psychiatric co-morbidity and methamphetamine-induced psychosis was also studied. METHODS: This was a cross-sectional study conducted concurrently at a teaching hospital and a drug rehabilitation center in Malaysia. Patients with the diagnosis of methamphetamine based on DSM-IV were interviewed using the Mini International Neuropsychiatric Interview (M.I.N.I.) for methamphetamine-induced psychosis and other Axis I psychiatric disorders. The information on sociodemographic background and drug use history was obtained from interview or medical records. RESULTS: Of 292 subjects, 47.9% of the subjects had a past history of psychotic symptoms and 13.0% of the patients were having current psychotic symptoms. Co-morbid major depressive disorder (OR=7.18, 95 CI=2.612-19.708), bipolar disorder (OR=13.807, 95 CI=5.194-36.706), antisocial personality disorder (OR=12.619, 95 CI=6.702-23.759) and heavy methamphetamine uses were significantly associated with lifetime methamphetamine-induced psychosis after adjusted for other factors. Major depressive disorder (OR=2.870, CI=1.154-7.142) and antisocial personality disorder (OR=3.299, 95 CI=1.375-7.914) were the only factors associated with current psychosis. CONCLUSION: There was a high risk of psychosis in patients with methamphetamine dependence. It was associated with co-morbid affective disorder, antisocial personality, and heavy methamphetamine use. It is recommended that all cases of methamphetamine dependence should be screened for psychotic symptoms.

Validation of Malay Version of Snaith-Hamilton Pleasure Scale: Comparison between Depressed Patients and Healthy Subjects at an Out-Patient Clinic in Malaysia.

BACKGROUND: The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-assessment scale designed to evaluate anhedonia in various psychiatric disorders. In order to facilitate its use in Malaysian settings, our current study aimed to examine the validity of a Malay-translated version of the SHAPS (SHAPS-M). METHODS: In this cross-sectional study, a total of 44 depressed patients and 82 healthy subjects were recruited from a university out-patient clinic. All participants were given both the Malay and English versions of the SHAPS, Fawcett-Clark Pleasure Scale (FCPS), General Health Questionnaire 12 (GHQ-12), and the Beck Depression Inventory (BDI) to assess their hedonic state, general mental health condition and levels of depression. RESULTS: The results showed that the SHAPS-M has impressive internal consistency (α = 0.96), concurrent validity and good parallel-form reliability (intraclass coefficient, ICC = 0.65). CONCLUSION: In addition to demonstrating good psychometric properties, the SHAPS-M is easy to administer. Therefore, it is a valid, reliable, and suitable questionnaire for assessing anhedonia among depressed patients in Malaysia.

A randomized, placebo-controlled trial of aripiprazole for the treatment of methamphetamine dependence and associated psychosis.

OBJECTIVES: The objectives of this study were to determine the efficacy and safety of aripiprazole for treatment of psychosis, retention and abstinence in patients with methamphetamine dependence. METHODS: This was a double-blind study where 37 methamphetamine dependent patients with history of psychosis were randomly assigned to receive aripiprazole (5-10 mg daily, N = 19) or placebo (N = 18) for 8 weeks. Follow-up evaluation was scheduled on day 7, 14, 28, 42 day 56 after enrolment. RESULTS: Participants on aripiprazole were retained significantly longer in treatment (48.7 days, SD =4.0) compared to placebo (37.1 days, SD =5.0). The Kaplan-Meier survival analysis showed that participants on aripiprazole were less likely to drop out of the study than the placebo group (P =0.02, χ(2) =5.3). Psychotic symptoms significantly decreased among those on aripiprazole as compared to placebo (P < 0.05). However, no statistically significance was found between the two groups in maintaining abstinence (generalised estimation equation (GEE) analysis, P = 0.41). No serious adverse events were reported in either group. CONCLUSION: Aripiprazole was no more effective than placebo in maintaining abstinence from methamphetamine use. However, it facilitated treatment retention and reduced the severity of psychotic symptoms. Aripiprazole was found to be generally safe and well tolerated.

Efficacy and safety of esketamine nasal spray in addition to standard of care in patients with major depressive disorder who have active suicidal ideation with intent: A subgroup analysis of the Asian cohort of ASPIRE I (a randomized, double-blind, placebo-controlled study).

This post-hoc analysis evaluated the efficacy and safety of intranasal esketamine in the Asian subgroup from ASPIRE I. Patients with major depressive disorder and suicidal ideation with intent received intranasal esketamine (n = 26) or placebo (n = 27), plus standard of care for 25 days. The primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to Day 2. The MADRS score improved in favor of esketamine (least squares mean difference: -3.8). No unexpected safety concerns were noted. The Asian subgroup showed a similar efficacy and safety profile as the total ASPIRE I cohort.

Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study.

BACKGROUND: Evaluate efficacy and safety of paliperidone palmitate 6-monthly (PP6M) for patients with schizophrenia in the Asian subgroup of a global, multicenter, noninferiority phase-3 study (NCT03345342). METHODS: Patients received paliperidone palmitate 1-monthly (PP1M, 100/150 mg eq.) or paliperidone palmitate 3-monthly (PP3M, 350/525 mg eq.) during the maintenance phase and entered a 12-month double-blind (DB) phase, wherein they were randomized (2:1) to PP6M (700/1000 mg. eq.) or PP3M (350/525 mg eq.). Subgroup analysis was performed for 90 (12.7%) patients from Asia region (India, Taiwan, Malaysia, Hong Kong, and Korea). Primary endpoint was time-to-relapse during DB phase (Kaplan-Meier estimates). Secondary endpoints were changes from baseline in Positive and Negative Syndrome Scale, Clinical Global Impression-Severity scale, Personal and Social Performance (PSP) scale score. RESULTS: In Asian subgroup, 91.9% (82/90) of patients completed DB phase (PP6M: 54/62 [87%]; PP3M: 28/28 [100%]). Median time-to-relapse was "not-estimable" due to low relapse rates in both groups. Estimated difference (95% confidence interval [CI]) between relapse-free patients in PP6M and PP3M groups of Asian subgroup was -0.1% [-8.5%, 8.4%] (global study population: -2.9% [-6.8%, 1.1%]). Mean change from baseline in secondary efficacy parameters was comparable between both groups, similar to the global study population. The incidence of extrapyramidal symptoms was higher in the Asian subgroup than in the global study population. CONCLUSION: Consistent with the global study population, PP6M was noninferior to PP3M in preventing relapse in patients with schizophrenia from the Asia region. Findings suggest the possibility of switching from PP1M/PP3M to twice-yearly PP6M without loss of efficacy and with no unexpected safety concerns.

Assessment of Psychometric Properties of the Malay Version of the Brief Resilience Scale (BRS-M) among Non-Academic Staff Working from Home during COVID-19 in Malaysia.

This study aims to validate the Malay version of the Brief Resilience Scale (BRS-M) in order for the scale to be available among the Malay-speaking population. Two hundred and ninety-eight non-academic staff completed the Malay version of the Brief Resilience Scale (BRS-M), Malay Copenhagen Burnout Inventory (CBI-M), and Malay Depression, Anxiety, and Stress Scale (M-DASS-21). To explore the factor structure of BRS-M, exploratory factor analysis (EFA) with the first group of 149 participants was conducted using FACTOR (v.11) software. Confirmatory factor analysis (CFA) was conducted from the data of the second group of 149 participants using SEM_PLS software. The EFA revealed a two-factor model; Factor 1 ="Resilience" and Factor 2 = "Succumbing". The CFA indicated a sufficient internal consistency reliability (Cronbach's α = 0.806 and McDonald's omega, ω = 0.812) and a good fit with SRMR = 0.031. BRS-M, CBI-M, and M-DASS-21 displayed a satisfactory concurrent validity result. Household income and marital status had significant association with resilience level, with low household income (B40 group) being a predictor of lower resilience. The BRS-M demonstrated favourable psychometric properties in terms of reliability and validity to assess the level of resilience among non-academic staff in Malaysia.

Stigma towards mental illness in Asian nations and low-and-middle-income countries, and comparison with high-income countries: A literature review and practice implications.

Background: Stigma related to mental illness (and its treatment) is prevalent worldwide. This stigma could be at the structural or organizational level, societal level (interpersonal stigma), and the individual level (internalized stigma). Vulnerable populations, for example, gender minorities, children, adolescents, and geriatric populations, are more prone to stigma. The magnitude of stigma and its negative influence is determined by socio-cultural factors and macro (mental health policies, programs) or micro-level factors (societal views, health sectors, or individuals' attitudes towards mentally ill persons). Mental health stigma is associated with more serious psychological problems among the victims, reduced access to mental health care, poor adherence to treatment, and unfavorable outcomes. Although various nationwide and well-established anti-stigma interventions/campaigns exist in high-income countries (HICs) with favorable outcomes, a comprehensive synthesis of literature from the Low- and Middle-Income Countries (LMICs), more so from the Asian continent is lacking. The lack of such literature impedes growth in stigma-related research, including developing anti-stigma interventions. Aim: To synthesize the available mental health stigma literature from Asia and LMICs and compare them on the mental health stigma, anti-stigma interventions, and the effectiveness of such interventions from HICs. Materials and Methods: PubMed and Google Scholar databases were screened using the following search terms: stigma, prejudice, discrimination, stereotype, perceived stigma, associate stigma (for Stigma), mental health, mental illness, mental disorder psychiatric* (for mental health), and low-and-middle-income countries, LMICs, High-income countries, and Asia, South Asian Association for Regional Cooperation/SAARC (for countries of interest). Bibliographic and grey literature were also performed to obtain the relevant records. Results: The anti-stigma interventions in Asia nations and LMICs are generalized (vs. disorder specific), population-based (vs. specific groups, such as patients, caregivers, and health professionals), mostly educative (vs. contact-based or attitude and behavioral-based programs), and lacking in long-term effectiveness data. Government, international/national bodies, professional organizations, and mental health professionals can play a crucial in addressing mental health stigma. Conclusion: There is a need for a multi-modal intervention and multi-sectoral coordination to mitigate the mental health stigma. Greater research (nationwide surveys, cultural determinants of stigma, culture-specific anti-stigma interventions) in this area is required.

The Pattern of Substance Use among People Who Use Drugs (PWUD) Receiving Treatment at University Malaya Medical Centre (UMMC) during the COVID-19 Pandemic and the Associated Factors.

There was a change in the pattern of substance usage among people who use substances during the COVID-19 pandemic period. This study aims to determine the effects of the COVID-19 pandemic on the pattern of substance usage among people who use drugs (PWUD) receiving treatment at the University Malaya Medical Centre (UMMC) as well as levels of anxiety and depression together with coping mechanisms and the factors affecting the pattern of substance use during COVID-19 pandemic period. A cross-sectional study was applied. The questionnaire used was the Mini-European Web Survey on Drugs (EWSD): COVID-19, Hospital Anxiety and Depression Scale (HADS), and Brief COPE Scale. In total, 130 PWUD were recruited. Of the participants, 36.2% of PWUD had not used/stopped the usage of illicit drugs/alcohol, 26.2% increased their usage, 20% decreased, and 14.6% used the same amount of illicit substances/alcohol during the COVID-19 pandemic period/restrictions. In addition, 28.5% of PWUD had an increased intention to seek professional support for drug counseling/treatment during the COVID-19 pandemic period. The prevalence anxiety and depression symptoms in PWUD according to HADS was 33% and 41.5%, respectively, with depression (p = 0.05) and isolation status (adjusted OR = 2.63, p < 0.05) being associated with an increase in alcohol/illicit substance use during the COVID-19 pandemic. PWUD who had increased their intention to seek professional support had significantly higher odds (adjusted OR = 4.42, p < 0.01) of reducing their alcohol/illicit substance use during the COVID-19 pandemic period. There were increased odds of maintaining alcohol/illicit substance usage among PWUD who practiced dysfunctional coping (adjusted OR = 3.87, p < 0.025) during the COVID-19 pandemic period. In conclusion, depression, isolation status, dysfunctional coping, and intention to seek professional support affected the pattern of alcohol/illicit substance use during the COVID-19 pandemic period. Strategies, substance rehabilitation/counseling, and proper mental health screening and the associated risk factors must be emphasized to prevent a further epidemic of substance use during the pandemic.

Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting.

Objective: To evaluate the long-term efficacy and safety of three-monthly paliperidone palmitate (PP3M) in Asian patients with stable schizophrenia in a naturalistic setting. Methods: Asian patients recruited between May 2016 and March 2018 from the prospective, single-arm, non-randomized, open-label, multi-national REMISSIO study were analyzed. Patients received PP3M over 12 months following ≥ 4 months of treatment with one-monthly paliperidone palmitate. The primary efficacy endpoint was the proportion of patients who achieved symptomatic remission. Other endpoints were changes in Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) total scores, hospitalization rates, and safety. Results: A total of 71 patients (23.3%) were Asian (South Korea: 33, Malaysia: 21, Taiwan: 17); 95.8% of patients completed the study. At LOCF, 71% of Asian patients achieved symptomatic remission compared to the overall population (n = 172/303, 56.8%). Improvements in mean (standard deviation) PANSS and PSP total scores from baseline to LOCF in Asian patients and overall population were clinically significant. A lower proportion of Asian patients had ≥ 1 psychiatric hospitalization after PP3M treatment (n = 1/70, 1.4%) than during the 12 months before (n = 12/70, 17.1%); compared with patients in the overall population after (n = 8/303, 2.6%) and before PP3M treatment (n = 37/303, 12.2%). The overall incidence of treatment-emergent adverse events across Asian patients was 62.9% compared to 53.1% in the overall population. Safety findings were consistent with the known safety profile of PP3M. Conclusion: Our findings confirm existing evidence on the efficacy and tolerability of PP3M in Asian patients with stable schizophrenia over 12 months of treatment.

Long-term Safety and Efficacy of Esketamine Nasal Spray Plus an Oral Antidepressant in Patients with Treatment-resistant Depression- an Asian Sub-group Analysis from the SUSTAIN-2 Study.

OBJECTIVE: To evaluate the long-term safety and efficacy of intranasal esketamine in patients with treatment-resistant depression from the Asian subgroup of the SUSTAIN-2 study. METHODS: SUSTAIN-2 was a phase 3, open-label, single-arm, multicenter study comprising a 4-week screening, 4-week induction, 48-week optimization/maintenance, and 4-week follow-up (upon esketamine discontinuation) phase. Patients with treatment-resistant depression received esketamine plus an oral antidepressant during the treatment period. RESULTS: The incidence of ≥ 1 serious treatment-emergent adverse event (TEAE) among the 78 subjects from the Asian subgroup (Taiwan: 33, Korea: 26, Malaysia: 19) was 11.5% (n = 9); with no fatal TEAE. 13 Asian patients (16.7%) discontinued esketamine due to TEAEs. The most common TEAEs were dizziness (37.2%), nausea (29.5%), dissociation (28.2%), and headache (21.8%). Most TEAEs were mild to moderate in severity, transient and resolved on the same day. Upon discontinuation of esketamine, no trend in withdrawal symptoms was observed to associate long-term use of esketamine with withdrawal syndrome. There were no reports of drug seeking, abuse, or overdose. Improvements in symptoms, functioning and quality of life, occurred during in the induction phase and were generally maintained through the optimization/maintenance phases of the study. CONCLUSION: The safety and efficacy of esketamine in the Asian subgroup was generally consistent with the total SUSTAIN-2 population. There was no new safety signal and no indication of a high potential for abuse with the long-term (up to one year) use of esketamine in the Asian subgroup. Most of the benefits of esketamine occurred early during the induction phase.

Antidepressant decision aid for major depressive disorder patients (ADAM): Development and pilot testing.

OBJECTIVES: This study aimed to develop and assess the effectiveness of an encounter decision aid for Malaysian patients with MDD to support treatment decision-making during the consultation. METHODS: The decision aid prototype was developed following a literature review and six focus groups. Alpha testing assessed its comprehensibility, acceptability, usability and desirability through user-centered cognitive interviews. Beta-testing evaluated preliminary evidence on its efficacy using the SDM Scale and PDMS. Feasibility was assessed by timing the consultation. RESULTS: The alpha testing demonstrated that the decision aid was patient-oriented, comprehensible, comprehensive, concise and objective with an appealing design. Beta-testing indicated that PtDA significantly increased patients satisfaction with SDM from patients' [83.32 (13.92) vs 85.76 (13.80); p < 0.05] and physicians' [81.07 (10.09) vs 86.36 (10.10); p < 0.05] perspectives and prepared the patients for decision making from the patients' [PDMS patients: 84.10 (12.69)] and physicians' [PDMS physicians: 83.78 (16.62)] perspectives as well. There was no change in the consultation time between the control and the intervention groups. CONCLUSIONS: We developed an antidepressant PtDA for Malaysian patients with MDD that increases patients' involvement in shared decision making and enhances their preparedness for decision making. PRACTICE IMPLICATIONS: Using the PtDA can support collaborative decision-making in routine clinical practice without extending the consultation time.

A Southeast Asia Consensus on the Definition and Management of Treatment-Resistant Depression.

Introduction: Despite the abundance of literature on treatment-resistant depression (TRD), there is no universally accepted definition of TRD and available treatment pathways for the management of TRD vary across the Southeast Asia (SEA) region, highlighting the need for a uniform definition and treatment principles to optimize the management TRD in SEA. Methods: Following a thematic literature review and pre-meeting survey, a SEA expert panel comprising 13 psychiatrists with clinical experience in managing patients with TRD convened and utilized the RAND/UCLA Appropriateness Method to develop consensus-based recommendations on the appropriate definition of TRD and principles for its management. Results: The expert panel agreed that "pharmacotherapy-resistant depression" (PRD) is a more suitable term for TRD and defined it as "failure of two drug treatments of adequate doses, for 4-8 weeks duration with adequate adherence, during a major depressive episode". A stepwise treatment approach should be employed for the management of PRD - treatment strategies can include maximizing dose, switching to a different class, and augmenting or combining treatments. Non-pharmacological treatments, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation, are also appropriate options for patients with PRD. Conclusion: These consensus recommendations on the operational definition of PRD and treatment principles for its management can be adapted to local contexts in the SEA countries but should not replace clinical judgement. Individual circumstances and benefit-risk balance should be carefully considered while determining the most appropriate treatment option for patients with PRD.