Endoxifen: A new, protein kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder.

OBJECTIVES: Endoxifen is a protein kinase C inhibitor. The objective of the present phase III study was to demonstrate the safety and efficacy of endoxifen in treating bipolar I disorder (BPD I) patients. METHODS: A multicenter, double-blind, active-controlled study was conducted using a daily dose of 8 mg endoxifen compared to 1000 mg divalproex, the current standard treatment, in patients with BPD I acute manic episodes with/without mixed features. The primary endpoint of our study was the mean change in total Young Mania Rating Scale (YMRS) score at day 21. RESULTS: Endoxifen (n = 116) significantly (p < 0.0001) reduced total YMRS score (from 33.1 to 17.8. A significant (p < 0.001) improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) score was observed for endoxifen (4.8 to 2.5). Early time to remission of the disease was observed with endoxifen compared to divalproex. None of the patients required rescue medication and there was no drug-associated withdrawals. Changes in Clinical Global Impressions-Bipolar Disorder and Clinical Global Impression-Severity of Illness scores showed that treatment with endoxifen was well-tolerated. CONCLUSIONS: Endoxifen at a low daily dose of 8 mg was as efficacious and safe in patients with BPD I acute manic episodes with/without mixed features.

Caregiver Burden in Alcohol Dependence Syndrome.

BACKGROUND: Alcoholism is a major threat to the individual as well as the society and the maximum burden of the illness is borne by the family. AIM: The study is aimed at assessing the pattern of burden on the caregivers of alcohol dependent patients and at assessing the relationship between the severity of dependence and the burden on caregivers. SETTINGS AND DESIGN: Cross-sectional descriptive study conducted in the Department of Psychiatry, Sri Ramachandra Medical College and Research Institute. MATERIALS AND METHODS: A cross-sectional assessment was done in 200 patients with alcohol dependence and their caregivers. The severity of dependence and the pattern of burden on caregivers were assessed. STATISTICAL ANALYSIS: The data thus collected was analyzed using SPSS version 20. RESULTS: The study demonstrates that caregivers of alcohol dependent patients reported significant objective burden and subjective burden. Furthermore, the severity of alcohol dependence and the domains of burden such as financial burden, disruption of family interaction, and disruption of family routine activities were positively correlated with high level of significance. CONCLUSION: The current study has illustrated that all the caregivers experienced significant amount of burden which has to be addressed for better treatment outcome of the patients.