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Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children aged from 2 to less than 7 years old.

Efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children and adolescents aged from 7 to less…

Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: a prospective randomised multicenter double-blind placebo-controlled clinical trial

To assess the efficacy of haloperidol to resolve delirium in adult critically ill patients and thereby render the patient awake and non-delirious.

Do effects of methylphenidate decline after long-term use? A double-blind, placebo-controlled cross-over study of effects of methylphenidate on cognitive functioning and real world behavior in treatment naïve children compared to effects after 9 months of treatment in clinical practice

The main objective of this study is to compare the acute effects of methylphenidate on behavioral and cognitive functioning in 6 to 12 year old treatment naïve children compared to the effects after nine months of treatment with methylphenidate in…

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer*s Disease Dementia (The DAYBREAK Study)

To test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD ascompared with placebo in patients with mild AD dementia.

Simvastatin addition to improve symptoms, cognition, metabolic syndrome and movement disorders in patients with recent-onset psychotic disorder.

The primary objective of this trial is to investigate the proposed beneficial effect of simvastatin on total symptom severity (PANSS) ascompared to placebo when given in addition to antipsychotic medication, and the effects on neurocognitive…

A blended eHealth intervention for sleep-disorders after acquired brain injury

The main objective of this study is to evaluate the efficacy of an eHealth cognitive behavioural intervention to treat insomnia in people with acquired brain injury.

Multicentre, Randomised, Controlled Trial of Gut-directed Hypnotherapy or Standard Medical Therapy in Children with Functional Nausea or Functional Dyspepsia

The aim of this study is to compare gut-directed hypnotherapy with standard medical treatment in children and adolescents with chronic idiopathic nausea or nausea due to functional dyspepsia. We will examine the effect of these treatments on…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE plus)

This study has been transitioned to CTIS with ID 2023-506918-45-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE)

This study has been transitioned to CTIS with ID 2023-506919-18-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

2.1 Primary The primary objective of the study is to evaluate the efficacy of troriluzole as adjunctive therapy compared to placebo in subjects with OCD who have had an inadequate response to their current OCD treatment based on the change in their…

A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer*s type.

The primary objective is to:* Evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo for thetreatment of agitation in patients with dementia of the Alzheimer*s typeThe secondary objectives are to:* Evaluate the effects of AVP…

Efficacy of an anti-inflammatory diet on global functioning, gut microbiome and health of patients with schizophrenia spectrum disorder, bipolar disorder, Alzheimer*s disease or Parkinson*s disease: a randomized controlled trial

The primary objective is to investigate the potential effect of the AIDP on global functioning in patients with SSD, BD, AD, and PD. Secondary objectives are to investigate whether the AIDP has a beneficial effect on cognitive functioning, well-…

STRENGTHS: Fostering responsive mental health systems in the Syrian refugee crisis

Primary Objective:To evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted PM+ intervention forSyrian refugees in The Netherlands.Secondary Objective(s):1. To translate and (culturally) adapt PM+ for use…

Targeted glucocorticoid administration to improve safety learning in PTSD patients with HPA axis dysregulation

This study has been transitioned to CTIS with ID 2024-516427-13-00 check the CTIS register for the current data. Substudy A: The primary objective will be to investigate the relationships between HPA axis dysfunction, early life adversity (ELA), and…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

This study has been transitioned to CTIS with ID 2023-506873-36-00 check the CTIS register for the current data. The primary objective of this study is: Part 1: To evaluate the efficacy of AL001 compared with placebo as measured by CDR® plus NACC…

*The MEtformin-LIfestyle in Antipsychotic users trial (MELIA): optimizing the use of metformin in the management of antipsychotic-induced weight gain.*

Objective: We aim to optimize the application of an existing drug, metformin, for a new indication, AiWG, by showing that metformin in combination with lifestyle interventions reduces AiWG compared to placebo in combination with lifestyle…

A randomised non-inferiority trial of esketamine versus electroconvulsive therapy in treatment-resistant depression

Phase 1:The primary objective of this trial is to investigate whether oral esketamine is non-inferior to ECT after eight weeks of individually optimized treatment, in participants with NTRD.Phase 2:To compare the efficacy of maintenance oral…

Imagery Rescripting for Obsessive Compulsive Disorder, Body Dysmorphic Disorder and Early Psychosis: a Multiple-Baseline Single-Case Experimental Design.

Primary Objective: To investigate the effectiveness of imagery rescripting on factors presumed to underlie the disorder, according to schema theory, and on OCD and BDD symptoms and psychosis. Primary objective is the course of schema or core beliefs…

Placebo-controlled trial in subjects at ultra-high risk for psychosis with omega-3 fatty acids in Europe

Primary objective of this randomised controlled trial is to compare transition rates to psychosis between individuals who are at UHR for developing psychosis and randomised to treatment with omega-3 fatty acids to those randomised to placebo, as…