12 results
The objectives are to assess the pharmacokinetic and pharmacodynamic effects of sub-anesthetic ketamine administration, to assess the optimal dose of ketamine and gender differences, to compare different oucome measures for psychomimetic symptoms…
The primary objective of the study is to determine whether TAK-653, in comparison to placebo, increases CNS excitability, assessed with TMS-evoked MEP in healthy subjects.Next to that, the study has the following goals: - To determine whether TAK-…
The aim of this study is to find a directly applicable intervention for acutely suicidal patients, so that the risk of these patients committing suicide is substantially lowered, leading to fewer actual suicides. To this end we propose a randomized…
The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT
Primary objectiveTo evaluate the CNS effects of a single intravenous dose of ketamine on functional brain networks by performing resting state functional magnetic resonance imaging (fMRI) in major depressive disorder (MDD) patients who fail to…
Primary ObjectiveThe primary objective of this study is to assess whether the antidepressant response to IV ketamine can be maintained by minocycline compared to placebo.Secondary ObjectivesThe secondary objectives of this study are:* To investigate…
Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…
Primary objective:To compare the efficacy with belantamab mafodotin vs pomalidomide plus low dose dexamethasone (pom/dex) in participants with relapsed/refractory multiple myeloma (RRMM)Secondary objectives:- To compare the overall survival with…
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
To evaluate the efficacy of blmf in patients with relapsed or refractory AL amyloidosis.
The aim of this study is to find a directly applicable intervention for acutely suicidal patients, so that the risk of these patients committing suicide is substantially lowered, leading to fewer actual suicides. To this end we propose a randomized…
Primary:To compare the efficacy of BM in combination with BOR/DEX with that of daratumumab in combination with BOR/DEX in participants with RRMMSecondary:Other efficacy outcomes. Safety and tolerability. PK. Anti-drug antibodies. Questionnaires (…