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.

Psychosocial rehabilitation of people living with mental illness: Lessons learned from community-based psychiatric rehabilitation centres in Gujarat.

INTRODUCTION: Psychosocial rehabilitation is the process that facilitates opportunities for persons with chronic mental illness to reach their optimal level of independent functioning in society and for improving their quality of life. However, such psychosocial rehabilitation centers are limited in India. AIMS: The present study assesses psychosocial rehabilitation centers (of urban day-care and rural residential rehabilitation center) operated by Ashadeep Charitable Foundation, a civil service organization and its effect on health outcomes of patients living with chronic mental illness. MATERIALS AND METHODS: Records of 170 cases were retrieved for secondary analysis of demographic information, diagnosis, duration of stay, and health outcomes. RESULTS: Rehabilitation activities included yoga, light physical exercises, group discussion, training for daily living skills, social skills, life skills, vocational training, individual, and family counseling. In addition, extensive outreach activities, mental health camps were also integral part of the rehabilitation activities. Patients who have accessed rehabilitation services were diagnosed with schizophrenia, psychosis, bipolar disorder, depression, and intellectual disability. The average duration of rehabilitation of patients (other than persons with intellectual disability) was ranged from three to four months. Out of those rehabilitated, 69% of them were successfully re-integrated with the family. CONCLUSION: Combination of pharmacological and psychosocial interventions are effective for re-integrate patients with mental illness to the family. This model of community-based rehabilitation has potential for scale-up.