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.
DESIGN AND METHODS: Four PPSs, including headache, chest pain, low back pain, and muscle pain, and subjective depressive symptoms were assessed using the Symptom Checklist-90-Revised.
FINDINGS: Out of 528 participants, 390 (73.9%) had at least one PPS. After adjusting for sex, depression severity, disability, fatigue, physical health status, and mental health status, PPSs were found to be associated with crying easily, blaming oneself, feeling lonely, feeling blue, and worrying too much.
PRACTICAL IMPLICATIONS: Almost three-quarters of Asian patients with MDD experience PPSs. PPSs are associated with some subjective feelings of depression.
MATERIALS AND METHODS: In this retrospective cohort study, data were extracted from the pharmacy database of University Malaya Medical Center (UMMC) responsible for dispensing records of patients stored in the pharmacy's Medication Management and Use System (Ascribe). We analyzed the use of psychotropics in patients from the oncology ward and cardiology from 2008 to 2012. Odds ratios (ORs) were adjusted for age, gender and ethnicity.
RESULTS: A total of 3,345 oncology patients and 8,980 cardiology patients were included. Oncology patients were significantly more often prescribed psychotropic drugs (adjusted OR: anxiolytic/hypnotic=5.55 (CI: 4.64-6.63); antidepressants=6.08 (CI: 4.83-7.64) and antipsychotics=5.41 (CI: 4.17-7.02). Non-Malay female cancer patients were at significantly higher risk of anxiolytic/hypnotic use.
CONCLUSIONS: Psychotropic drugs prescription is common in cancer patients. Anxiolytic/hypnotic prescription rates are significantly higher in non-Malay female patients in Malaysia.
OBJECTIVE: To study the efficacy of 5 minutes of mindful breathing (MB) for rapid reduction of distress in a palliative setting. Its effect to the physiological changes of the palliative cancer patients was also examined.
METHODS: This is a randomized controlled trial. Sixty palliative cancer patients were recruited. They were randomly assigned to either 5 minutes of MB or normal listening arms. The changes of perceived distress, blood pressure, pulse rate, breathing rate, galvanic skin response, and skin surface temperature of the patients were measured at baseline, after intervention, and 10 minutes post-intervention.
RESULTS: There was significant reduction of perceived distress, blood pressure, pulse rate, breathing rate, and galvanic skin response; also, significant increment of skin surface temperature in the 5-minute MB group. The changes in the 5-minute breathing group were significantly higher than the normal listening group.
CONCLUSION: Five-minute MB is a quick, easy to administer, and effective therapy for rapid reduction of distress in palliative setting. There is a need for future study to establish the long-term efficacy of the therapy.
METHODS: This study is from the MyBCC cohort study. Two hundred and twenty one female breast cancer patients were included into the study. They were assessed at the time of diagnosis, 6 months and 12 month using Hospital Anxiety and Depression Scale (HADS) and distress thermometer. The information on age, ethnicity, treatment types and staging of cancer were collected.
RESULTS: 50.2%, 51.6% and 40.3% of patients had perceived high level of distress at baseline, 6 months and 1 year after diagnosis. Those with high perceived level of distress had significant higher anxiety scores even after adjusted for the underlying depressive scores (Adjusted OR at baseline = 1.28, 95% CI = 1.13-1.44; adjusted OR at 6 months = 1.27, 95% CI = 1.11-1.45; adjusted OR at 12 months = 1.51, 95% CI = 1.29-1.76). There were no significant differences in the depressive scores between the subjects with either low or high distress level. There was reduction in perceived level of distress, anxiety and depression scores at 12 months after the diagnosis. The decrease of distress was positively correlated with the reduction of anxiety scores but not the changes of depressive scores (r' = 0.25).
CONCLUSION: Anxiety is a more significant psychological state that contributed to the feeling of distress in breast cancer as compared with depression. Levels of anxiety at diagnosis in this study would justify screening for anxiety, early identification and therapy for maintaining the psychological well-being of breast cancer patients. Further studies will be needed to measure the effectiveness of therapeutic interventions.
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.
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