25 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…
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…
This study looks if the third generation antipsychotic aripiprazole can improve activity of the prefrontal cortex and cognitive and social function, when compared to the second generation antipsychotic risperidone.
The main objective of the study is to determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy. Secondary objectives are to assess pulmonary toxicity by…
Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…
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…
To perform a pilot study to determine the feasibility of conducting a two-arm phase I trial and to determine the recommended dose level for phase II (RP2D) study and assess the safety of the combination olaparib and melphalan in patients with…
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.
The potential for risperidone to induce hyperprolactinemia in pediatric patients is well known.However, the effects of drug-induced serum prolactin elevations on growth and sexual maturation havenot been as well characterized in pediatric…
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…
Firstly, determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan.Secondly, evaluation of toxicity, tumor response and survival after IHP…
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…
Primary Objective:To compare the progression-free survival (PFS) of transplant-ineligible subjects with newly diagnosed multiple myeloma who are treated withcarfilzomib, melphalan, and prednisone (CMP) versus those treated with bortezomib (Velcade…
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…
Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.
To assess the feasibility, defined as discontinuation rate, of a dose-adapted MPV scheme in MM patients >= 75 years
The primary objective of the randomized part of the protocol is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non…
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for…