6 results
The primary objective of this study is: To study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for…
The primary objective of this study is to test the hypothesis that risperidone given orally in a dose of 0.25 - 3.0 mg/d depending on body weight (eq. to approximately 0.01 - 0.04 mg/kg/d) for 12 weeks is superior to placebo in reducing disruptive…
The primary objective is to test the hypothesis that, after at least 15 weeks of daily administration (4 for titration, 7 of relatively stable dose, 4 at fixed doses; Study Period II), risperidone given orally in a dose of 0.25 - 3.0 mg/d depending…
Primary Objective: To investigate the behavioral effects of controlled discontinuation as well as the feasibility of discontinuing currently ongoing treatment with risperidone in children and adolescents with behavioral problems who have used…
Part A: healthy volunteers Primary objective- To determine safety and tolerability of a single dose of VB5-845D-800CW in healthy volunteers.Secondary objective- To determine the pharmacokinetics of VB5-845D-800CW by measuring fluorescence in blood…
The study is designed to investigate why withdrawal of off-label antipsychotic drugs for behavioral problems in people with intellectual disability often fails by comparing two blinded groups (withdrawa group versus control group). This has led to…