21 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.
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 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…
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 phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…
Primary: 1/ To determine the higher of the tolerated dose of INC280 tablets with food between 300 and 400 mg BID in patients with cMET dysregulated advanced solid tumors. 2/ To assess the PK of INC280 with food.Secondary: To assess the safety of…
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: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity 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…
The aim of this prospective, multicentre randomized phase II study is to evaluate the safety and efficacy of the combination of capmatinib and spartalizumab in subjects with EGFR weight (for exon 19 deletions and exon 21 L858R substitution mutations…
Progesterone for Breast Development in Trans Women; Assessment of effects and safety -a pilot trial-
To explore the effects on breast development of addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy. Secondary objectives include safety and patient satisfaction, mood, and sleep.
In this study, we want to find out whether the new drug capmatinib is more effective (i.e. better inhibits the growth of cancer cells) than the widely used chemotherapy docetaxel. In addition, it will be assessed whether treatment with capmatinib is…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
Primary: To evaluate the antitumor activity of INC280, as measured by overall response rate (ORR) as by a blinded independent review committee, by cohort.Secondary: Duration of response (DOR), ORR and DOR by investigator, time to response (TTR),…
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…