Clinical Research Directory

Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression

The goal of this clinical trial is to learn if a multi-layered digital and pharmacogenomic intervention works to prevent suicide re-attempts in adults with depression. It will also evaluate the safety and effectiveness of continuous digital monitoring, digital safety plans, and precision medication management. The main questions it aims to answer are: * Does the multi-layered intervention lower the rate of suicide re-attempts over a 6-month period compared to standard care? * How do digital tools and genetic-guided prescribing affect depressive symptom severity and treatment-emergent adverse drug reactions? Researchers will compare three groups: participants receiving standard care plus digital monitoring, participants receiving standard care plus digital monitoring and an interactive digital safety plan, and participants receiving standard care plus digital monitoring, a digital safety plan, and pharmacogenetic-guided care. Participants will: * Install study smartphone applications (MeMind and eB2 Mindcare) to track daily mood, stress, and activity patterns through active and passive digital phenotyping. * Authorize historical digital trace extraction via Google Takeout and provide baseline blood samples for genetic, multi-omics, and pharmacokinetic profiling. * Complete regular clinical checkups and questionnaire assessments at baseline and at weeks 4, 8, 12, and 24.

Comparing 10 Hz rTMS and iTBS for Adolescent Depression

This trial compares two transcranial magnetic stimulation (TMS) protocols-10 Hz rTMS and intermittent theta burst stimulation (iTBS)-in adolescents with major depressive disorder. Eighty participants aged 11-19 years will be randomly assigned to receive either 10 Hz rTMS or iTBS over a two-week period. Clinical symptoms, cognitive function, brain imaging, and neurophysiological measures will be assessed at baseline, immediately post-treatment, and at a 1-month follow-up to evaluate both the immediate and sustained therapeutic effects and underlying mechanisms.

Exploring the Role of the Prefrontal Cortex in Decision-Making

The goal of this study is to examine whether high-definition transcranial direct current stimulation (HD-tDCS) can influence decision-making for emotionally valenced content in younger and older adults, with or without major depression. The main questions are: In healthy adults, does brain stimulation modulate how people respond to emotionally valenced content during a decision-making task? What happens in the brain during modulation? Do these effects differ between younger and older adults? In adults with depression, does brain stimulation help shift attention towards positive content during the task? What happens in the brain? Are these effects moderated by age (younger vs. older adults)? The investigators will compare participants who receive real stimulation to those who receive sham (placebo) stimulation. Participants will: Receive high-definition transcranial direct current stimulation (HD-tDCS) of the dorsolateral prefrontal cortex (DLPFC) Perform a decision-making task involving emotionally valenced words Complete the task while undergoing a brain scan using ultra-high field 7 Tesla magnetic resonance imaging (MRI) to measure brain activity

Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.

The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years. We wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial. The participants will be randomised to one of the following three treatments: 1. Standard treatment provided by a general practitioner (i.e. the general practitioner treats the patient as he/she would normally do, when treating a patient with depression). 2. Standard treatment provided by a psychologist in the form behavioural therapy (i.e. the psychologist treats the patient as he/she would normally do, when treating a patient with depression). 3. A step-by-step treatment plan carried out by a general practitioner. The plan includes pre-determined follow-ups and a pre-determined, structured plan for which medications to use and when to increase dose or switch medication. The hypothesis is that a structured and step-by-step treatment approach regarding patients with depression, treated in general practice, is more effective than standard treatment provided by a general practitioner and a psychologist. All the participants will: 1. Receive one of the three treatments for 12 weeks. 2. Have meetings with the project staff every 4 weeks (week 0, 4, 8 and 12) were rating scales will be completed, e.g. a rating scale to measure progress or deterioration in the participant's depression.

Detection Algorithm for Recurrence or Relapse of Depression Thanks to a Smartwach

Globally, 3.8% of the population, or approximately 280 million people, suffer from depression. In France, 12.5% of adults experienced a major depressive episode (MDE) in 2021, with women being twice as affected as men. MDEs often require pharmacological treatment, but only one-third of patients achieve full remission after eight weeks of treatment. Relapse and recurrence are common, especially after the first episode, with the risk increasing with each subsequent episode. Depression significantly impacts morbidity, mortality, and functioning, and is the leading predictor of suicide. The Dalia mobile application, developed collaboratively with patients and psychiatrists, uses a smartwatch to monitor physiological parameters (e.g., heart activity, sleep quality, moods) to detect early signs of relapse or recurrence. This study aims to identify variations in clinical biomarkers during remission or recovery and validate Dalia's sensitivity in detecting relapse compared to psychiatric diagnosis. Early detection could improve depression management and reduce the burden of the disease.