123 results
The proposed study aims to examine: I. whether MDD-patients with a high TRD-level have diminished reward/reinforcement learning, dysfunctional dopaminergic, glutamatergic and/or GABA-ergic neurotransmission (relative to no-TRD patients/controls) II…
Primary objectives:(1) To determine the safety and tolerability of pembrolizumab. (2) To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (…
The overall objectives of the iSPOT-D trial are to use standardised genetic-brain-cognitionprotocols to:1. Identify markers of MDD as a diagnostic group and its subtypes2. Identify markers which change with acute (8 weeks) drug treatment in MDD3.…
Investigating the bioequivalence of the new formulation of escitalopram.
Investigating the bioequivalence of the new formulation of escitalopram.
Observe the adherence rate of antidepressants during pregnancy and secondary exploration of possible factors which contribute to non-adherence
Primary Objectivea) Phase I (Safety Run-in) The primary objective of the Phase I Safety Run-in part is to investigate the safety of IO102 in combination with either pembrolizumab alone or pembrolizumab and chemotherapy (carboplatin and pemetrexed)…
Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…
To assess the safety and biodistribution of 89Zr-pembrolizumab and its uptake in tumor and target irAE tissues
Objectives: To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1 positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy(b) Pembrolizumab versus…
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with unresectable or…
Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…
Primary:1) To compare OS in subjects with squamous cell carcinoma of the Esophagus.2) To compare OS in subjects with PD-L1 Combined Positive Score (CPS)*10%3) To compare OS in all subjectsSecondary:1) To evaluate the progression free survival (PFS)…
To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review
Inhibition of CYP2D6 enzymes by SSRIs may lead to reduced endoxifen plasma concentrations and thereby possibly influence tamoxifen treatment outcome. Paroxetine is a potent CYP2D6 inhibitor and strongly reduces endoxifen plasma concentrations.…
The objective of the study is to evaluate various doses of SSR125543 in first patients (outpatients with a major depressive disorder), evaluate collected information concerning tolerability, efficacy en safety. The same infomation will be evaluated…
To investigate if jerks and psychiatric disorders in patients with dystonia are associated with a hyperdopaminergic/ hyposerotonergic system and whether reversal of a hyposerotonergic state has a therapeutic effect.
PRIMARY OBJECTIVE· 1. To study the effect of escitalopram versus placebo in the treatment of abdominal pain, in IBS patients with panic disorder.SECONDARY OBJECTIVES· 2.1. To assess the effect of escitalopram on gastrointestinal and psychiatric…
Primary Objectives:(1) Objective: To compare the overall survival (OS) in subjects with R/M HNSCC treated with pembrolizumab compared to standard treatment.Secondary Objectives:PD-L1 Positive Population:(1) Objective: To compare Overall Survival (OS…
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…