Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine.

Background: There is a need for a rapid-acting, non-injection, acute treatment for agitation.

Aims: To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.

Method: This phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.

Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate.

Objective: To describe clinically relevant effects of lisdexamfetamine dimesylate (LDX) on emotional expression (EE) in children with ADHD.

Method: Children with ADHD participated in a 7-week, open-label, LDX dose-optimization study. Expression and Emotion Scale for Children (EESC) change scores were analyzed post hoc using two methods to determine proportion of participants with different categories of clinical response based on (a) clinically significant (movement >2 SD from baseline mean)/reliable change (not due to measurement error) and (b) standard error of measurement (SEM) as a measure of clinically meaningful change.

A double-blind placebo-controlled study of Org 3770 in depressed outpatients.

90 patients between 18 and 65 years, with a DSM-III diagnosis of moderate or severe major depressive episode, were randomized to 6 weeks of treatment with Org 3770 or placebo in a double-blind trial. On main efficacy parameters, the 17-item HAMD, MADRS and CGI, Org 3770 was significantly superior to placebo (P < or = 0.05) in weeks 1-4 and at endpoint and recommended as continuation treatment to significantly more patients.