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Preventing Relapse After Successful Electroconvulsive therapy (ECT) for Depression: A randomized controlled trial on lithium as add-on to personalized maintenance ECT

Although electroconvulsive therapy (ECT) is an effective treatment for depression, preventing relapse after successful ECT remains a major challenge. In the PRASED-study we evaluate the effectiveness of three strategies to reduce relapse: an…

Depression and Microbiota: Biological, and Psychological markers of treatment response

Primary objective: To investigate changes in biological and psychological markers for patients with an unipolar depressive disorder during treatment.. In specific, we will study the relationship between depressive symptomatology with changes in…

A pilot study on oral esketamine for depression and demoralization in patients with advanced cancer receiving palliative care

Evaluation of the feasibility of a trial on the efficacy of oral esketamine for the treatment of depression and/or demoralization in patients with advanced cancer who receive palliative care.

A phase I, open-label trial to investigate metabolism and pharmacokinetics of a single dose of [14C] BI 1358894 administered as oral solution (Part 1) and multiple doses of BI 1358894 administered as film-coated tablets (Part 2) in healthy male volunteers

The purpose of this study is to investigate how quickly and to what extent BI 1358894 is absorbed and eliminated from the body (this is called pharmacokinetics) when given as a single dose / multiple doses. BI 1348894 will be labelled with Carbon-14…

Understanding mechanisms of prevention of depression: a mechanistic cross-over trial of mindfulness vs. fantasizing to reduce perseverative cognition underlying vulnerability for depression

The main objective of study 1 is to test whether psychological and psychophysiological indices of PC are differentially affected by fantasizing vs. mindfulness in a cross-over design in 50 remitted MDD patients vulnerable for depressive relapse. The…

How does the brain learn about positive and negative things?

The aim of this study is to compare directly the activity of dopamine (DA) and norepinephrine (NE) in humans when they perform tasks that measure different aspect of cost-benefit evaluation (decision-making and learning) It is expected that blockade…

Deep brain stimulation of the medial forebrain bundle for patients with treatment-resistant depression

Establishing efficacy of MFB DBS for TRD by comparing active DBS with sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life, cost-effectiveness, (neuro)psychological and neuroimaging measures.

A virtual reality experience to improve psychoeducation for depression

In the present study our main aim is to assess whether VR psycho-education will lead to a larger decrease in feelings of self-stigma for the patient, as compared to traditional psychoeducation. Our secondary aim would be to test the effect of the VR…

Neurological MRI-based biomarkers for treatment navigation in depression

Identification of MRI-based biomarkers to predict clinical outcome of major depressive disorder in comparison with healthy controls. Outcome is defined by level of depressive and cognitive symptomatology and related comorbidity.

Preventive Cognitive Therapy with Neurocognitive Remediation Therapy for partially remitted depressed patients

To investigate the added effectiveness of Preventive Cognitive Therapy (PCT) with oNCRT as compared to PCT on depressive symptomatology over a one-year period in 115 partially remitted depressed patients. We hypothesize that oNCRT is able to augment…

Randomized, Double-Blind, Double-Dummy, Placebo-Controlled 4-way Crossover Study to assess the Pharmacodynamics and Pharmacokinetics of Oral and Intravenous S-Ketamine in Healthy Volunteers

Primary Objectives* To investigate the effects of PO and IV S-ketamine and its metabolite S-norketamine on functional CNS tests up to 6h (acute effects) and 24h (delayed effects) after administration using NeuroCart test battery in healthy subjects…

Longitudinal evaluation of an MRI-based predictive algorithm for early assessment of treatment response in depression (LEOPARD study)

To replicate the DEPREDICT algorithm (formed from external cohorts/datasets) as a valid tool for prediction of AD treatment non-response, we aim to recruit 80 patients who are treat-ed with an SSRI or SNRI and are eligible and willing to have an MRI…

A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

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 (…

A multicentre study to assess safety and efficacy of COMP360 in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU)

The primary objective of this study is to assess the long-term efficacy of COMP360 with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg…

A randomised controlled trial of fMRI-neurofeedback in depression

Primary Objective: To determine whether NFE + standard care is superior to standard care alone in the treatment of depression. Secondary Objective(s): To assess correlations between NFE success and brain activation / clinical changes; to assess…

Effectiveness of EMDR for adolescents with Major Depressive Disorder

This study aims to investigate the effectiveness of EMDR (n=32) in comparison to a waiting list in (n=32) adolescents (12-18 years) with a primary diagnosis of MDD (DSM-5; American Psychiatric Association, 2013). It is hypothesized that the…

The neurobiological correlates of anhedonic depression in Parkinson*s disease; associations between dopamine function and functional pathways

First aim is to quantify DA function of meso-limbic/cortical DA pathways (measured with 18F-FE-PE2I Position Emission Tomography (PET) in PD-depression with or without anhedonia (vs. non-depressed PD). Second aim is to associate these DAT findings…

LIFE: development of a personalized lifestyle intervation for patients in psychiatric outpatient care and general practice

The goal of the study is to develop a state-of-the art- lifestyle intervention that is achievable and acceptable for patients with a bipolar and severe recurrent depressive disorder. and patients in general practice with depression

Storytelling and Training to Advance Individual Recovery Skills (STAIRS): a blended module for patients recovering from depression. A pilot study.

Prior to conducting an RCT to study the efficacy of STAIRS, we conduct a pilot to (1) investigate the usability, feasibility and acceptability of the program and (2) to investigate the feasibility and acceptability of the intended measurement method…

An Open-label, Randomized Study in Healthy Participants to Investigate Effects of Food (high-fat) and Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-67953964.

- To assess the effect of food (high-fat) on the bioavailability and pharmacokinetic (PK)- profile of a solid dosage formulation of JNJ-67953964.- To assess the effects of repeated QD administration of 200 mg of itraconazole (steady state) on the…