8 results
Primary ObjectivesThe primary objective is to assess the efficacy (primarily through time to relapse) of long-acting injectable (LAI) paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over…
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 goal of this study is to investigate the effect of low doses of mirtazapine and quetiapine on sleep, assessed using polysomnography and subjective sleep measures, of healthy subjects whose sleep will be disturbed by auditory stimuli (…
Primary objective:To explore the natural time course of specific [18F]AV-1451 binding in patients with subjective cognitive decline after two and four year follow upa. To compare rate of change in [18F]AV-1451 binding according to baseline amyloid…
This protocol is a follow-up of a previously submitted protocol (Evaluation of [18F]AV-1451 kinetic modelling in patients with Alzheimer*s Disease and healthy controls, protocol nr. 2014.519), in which the optimal (simplified) kinetic model for [18F…
Primary objectiveThe primary objective of the study is to determine the effect of lucerastat on neuropathic pain in subjects with Fabry disease (FD).Secondary objectives* To determine the effects of lucerastat on gastro-intestinal (GI) symptoms (…
Primary objective:The primary objective of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release(XR), both in combination with a continuing selective serotonin reuptake inhibitor (…
Primary objectiveThe primary objective of the study is to determine the long term safety and tolerability of lucerastat in subjects with Fabry disease (FD).Secondary objectives* To evaluate the effect of lucerastat on renal function and cardiac…