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.

Tolerability of zotepine in Indian patients: Preliminary experience.

Zotepine is an antipsychotic used in Japan and Europe for years and recently being introduced in Indian markets. It is claimed to be particularly effective for negative symptoms, and somnolence and weight gain are the most common side effects. Our aim is to share our clinical experience of use of zotepine with respect to its tolerability.

Comprehensibility of translated informed consent documents used in clinical research in psychiatry.

Background: Informed consent forms are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average subject actually understands of the information contained in these informed consent forms is uncertain.

Aim: In a cross sectional study, the translated informed consent forms used in psychiatric clinical trials were assessed with respect to their ease of readability.