13 results
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…
Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…
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…
Primary objectives:* To explore the comparative bioavailability between 12.5 mg of Risperdal® Consta® prepared from a 25 mg dose strength of Risperdal® Consta® EU-sourced, and 12.5 mg of Risperdal® Consta® prepared from a 12.5 mg dose strength…
Subcutaneous stimulation as add on therapy to spinal cord stimulaion to treat low back pain in FBSS.
The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief. We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back pain…
Main: to examine the comparative and combined effects of aggression replacement training (ART) and Risperidone on aggressive behaviours among adolescents with aggression problems ages 14-21 across clinical and non clinical settingsSecondary: to…
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…
The primary objective of this study is to test the hypothesis that discontinuation of antipsychotics does not lead to deterioration in functioning as measured by the ABC.
Objective: To test the hypothesis that clozapine treatment compared to risperidone treatment is associated with a significant reduction in subjective craving and in a lower activity of the different functional craving pathways and their associated…
Primary study objective Is the reduction of 1 to several antipsychotic antipsychotic associated with more relapse? Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is defined as: - An absolute increase of> 2 on one of…
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…
In SPACe 2 STAR, we aim to reach further, we will test whether application of TDM in clinical practice is indeed able to reduce the number/severity of metabolic side effects, while retaining clinical effectiveness in children by means of a…
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…