[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondation FondaMental\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,88,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100054275","improving-mental-health-in-vulnerable-populations-through-micro-interventions-and-social-prescribing-a-factorial-randomized-trial-100054275",false,"NCT07697807","Improving Mental Health in Vulnerable Populations Through Micro-Interventions and Social Prescribing: A Factorial Randomized Trial","A Full Factorial Randomized Trial Assessing the Incremental Effects of Personalized Micro-interventions and Social Prescribing on Mental Health of Vulnerable Populations - Individuals in Socio-economically Disadvantaged Conditions (France) Participating in a Multicenter Trial","ReconnectedTRI","Inclusion Criteria:\n\n* Mental well-being status: Classified on the MHC-SF as either \"Languishing\" or \"Moderately Mentally Healthy.\"\n* Age: Must be 18 years of age or older.\n* Location: Resident of disadvantaged areas within the Val-de-Marne department, defined for this study as municipalities with the highest percentage of households living below the poverty line (more than 20% of households, according to INSEE data).\n* Skills: Must demonstrate a sufficient level of linguistic and cognitive understanding to communicate with the research team and complete the pre-screening process.\n* Resources: Must have access to a smartphone with an internet connection for the duration of participation in the study.\n\nExclusion Criteria:\n\n* Severe mental illness: Self-report screen: \"Do you currently have any of the following mental disorders diagnosed by a psychologist, psychiatrist, or other mental health professional?\" (checklist includes schizophrenia, bipolar, psychosis, severe depression with hospitalisation).\n* Mental Health treatment: Self-report screen:\n\n\"Do you currently receive psychological treatment for a mental disorder?\" \"Have you started taking prescribed medication for psychological or psychiatric problems (e.g., anxiety, depression, sleep problems) within the past four weeks?\" (yes\u002Fno)\n\n* Inability to commit to engagement: Self-report screen: \"Are you able and willing to use the digital tool weekly for the next 6 weeks and complete 4 surveys?\"\n* Insufficient language comprehension: Basic comprehension check. Part of (electronic or in-person) consent procedure: prospect can read and understand the study information.",true,"ALL","18 Years",{"count":21,"type":22},256,"ESTIMATED","OBSERVATIONAL","This full factorial trial is part of the RECONNECTED project (www.reconnected-project.eu). RECONNECTED involves a consortium of 11 European partners responding to global societal developments affecting mental wellbeing of vulnerable citizens. The project will offer a digital support system with culturally adapted and personalised intervention tools to various vulnerable populations that are understudied and difficult to reach with regular mental health interventions (i.e. youth, people with low SES, migrant populations, and older adults). The digital support system targets both individual and social factors simultaneously (i.e. mental health literacy, psychological resilience and social connectedness) to maximise health benefits. The main aim of this trial is to examine if personalised micro-interventions and social activation add wellbeing benefits to mental health literacy. The additional effects of personalised micro-interventions and social activation to mental health literacy will be tested through nine full factorial trials in nine European countries. The second objective is to evaluate whether integrating a machine learning algorithm into personalised micro-interventions improves the effectiveness of the personalised micro-interventions compared to the standard version. This analysis will be conducted using pooled data from the nine trial sites. The third objective is to conduct a process evaluation to assess the feasibility of the digital support system, including usability, perceived usefulness, overall satisfaction, potential unintended negative effects, and engagement.",[26],"Global Mental Health",[28,29,30,26],"Resiliance","Social activation","Literacy","NOT_YET_RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":22},"2026-07-01",{"date":39,"type":22},"2027-10-01",{"name":41,"class":42},"Fondation FondaMental","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100624985","gynmdd-add-on-to-supportive-psychotherapy-in-mild-to-moderate-depression-100624985","NCT07416747","GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression","Multicenter Interventional Real-world Study Evaluating the Impact of the Dietary Supplement GynMDD Administered as an add-on to Supportive Psychotherapy in Patients With Mild to Moderate Depression.","SWING","Inclusion Criteria:\n\n* Adults aged 18 to 65 years, inclusive\n* The main reason for consultation is a suspected depressive episode\n* MADRS score between 15 and 34, indicating mild to moderate depression\n* No suicidal risk, defined as a score of 0 on item 10 of the MADRS scale\n* Body Mass Index (BMI) between 19 and 29 (inclusive)\n* Signed informed consent, confirming that the participant understands the purpose and requirements of the study and agrees to comply with the procedures (including scheduled supportive psychotherapy sessions)\n* Affiliation with the French national health insurance system or beneficiary of such coverage\n\nExclusion Criteria:\n\n* History of severe psychiatric disorders or currently undergoing supportive psychotherapy\n* Confirmed suicidal risk, defined as a score between 1 and 6 on MADRS item 10\n* Current treatment with antidepressants (AD)\n* MADRS score \\> 34\n* Conditions in which probiotic administration is not recommended (e.g., immunodeficiency, presence of a venous catheter)\n* Allergy to any component of the placebo or the GynMDD dietary supplement\n* Current consumption of probiotic-based dietary supplements\n* Recent infectious episodes that may require antibiotic therapy\n* Current treatment with anxiolytics\n* Long-term chronic anti-inflammatory treatment\n* Alcohol abuse, defined as a consumption of 10 standard drinks per week or more\n* Use of illicit drugs or substances of abuse\n* Inability to provide informed consent\n* Participation in another clinical study within the past 12 months\n* Pregnant or breastfeeding women\n* Patients without health insurance\n* Individuals under legal protection, guardianship, trusteeship, or any other protective measure","65 Years",{"count":53,"type":22},168,"INTERVENTIONAL",[56],"NA","The goal of this clinical trial is to learn whether the dietary supplement GynMDD, when taken as an add-on to supportive psychotherapy, can improve symptoms of mild to moderate depression in adults aged 18 to 65. The main questions it aims to answer are:\n\nDoes adding GynMDD to supportive psychotherapy lead to a greater reduction in depressive symptoms (measured by the MADRS scale) compared with supportive psychotherapy plus placebo?\n\nDoes the supplement also improve digestive well-being and influence gut microbiota profiles over the course of treatment?\n\nResearchers will compare patients receiving supportive psychotherapy + GynMDD to those receiving supportive psychotherapy + placebo to see if GynMDD provides additional benefits beyond standard care.\n\nParticipants will:\n\n* Attend regular appointments with their general practitioner\n* Complete one supportive psychotherapy session per week for 8 weeks\n* Take a daily dose of GynMDD or placebo\n* Complete weekly self-assessment questionnaires on mood, digestive symptoms, and any side effects via a mobile app\n* Provide two stool samples (at the start and end of the study) for microbiota analysis",[59,60,61],"Depression","Depression Disorder","Depression in Adults",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"Gut-Brain Axis","Gut Microbiota","GynMDD","Mild Depression","Moderate Depression","MADRS","Supportive Psychotherapy","Psychotherapy","Dietary Supplement","Probiotic Supplement","Real-World Study","Mental Health","Curcumin","L-Glutamine","Randomized Controlled Trial","PHQ-9","2026-02-13",{"date":81,"type":35},"2026-02-18",{"date":83,"type":22},"2026-03",{"date":85,"type":22},"2027-11",{"name":41,"class":42},1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":87},"100583136","medical-comorbidities-in-bipolar-disorder-100583136","NCT06872398","Medical Comorbidities in Bipolar Disorder","Medical Comorbidities in Bipolar Disorder : Clinical Validation of Risk Factors and Biomarkers to Improve Prevention and Treatment;","BIPCOM","Inclusion Criteria:\n\n* Primary diagnosis of BP I, BP II, or BP NOS\n* Have had at least one contact with mental health services in the past year\n* Be aged between 18 and 65 years old\n* Have signed an informed consent\n\nExclusion Criteria:\n\n* Projected move within the next year.\n* Severe psychiatric comorbidities (schizophrenia spectrum disorders).\n* Severe cognitive impairment.\n* Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST.",{"count":97,"type":22},80,"Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6). BIPCOM will be implemented through continuous consultations with stakeholders (scientific and patients' associations, users and families), for ensuring results' acceptability and transferability. The successful implementation of the project will have a significant impact upon the general health of people with BD, eventually leading to lower mortality rates and reduced incidence of severe disabilities, whilst providing reliable methods and tools for patients' stratification and personalized treatments.",[100],"Psychiatric Disorder","RECRUITING","2025-03-10",{"date":104,"type":35},"2025-03-12",{"date":106,"type":35},"2024-10-11",{"date":108,"type":22},"2026-12",{"name":41,"class":42},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":54,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":87},"100476199","familial-and-functional-study-of-genetic-variants-identified-in-people-with-schizophrenia-bipolar-disorder-autism-spectrum-disorder-or-resistant-depression-100476199","NCT05480826","Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression","GENI","Inclusion Criteria:\n\n* For patients:\n* Subjects suffering from (according to DSM IV criteria) : Bipolar disorder, Unipolar depression, Schizophrenia, Autism spectrum disorder\n* Age over 18 years\n* Subject affiliated to the social security system\n* Including patients under guardianship, curatorship,\n* Patients included in the Fondation FondaMental cohort whose genetic analyses have revealed the need for comparative and functional genetic studies.\n* Having signed the consent form\n\nFor relatives :\n\n* Age over 18 years\n* Relative of patient included in the Fondattion FondaMental cohort\n* Including relative under guardianship, curatorship\n* Having signed the consent\n* Affiliated to social security\n\nExclusion Criteria:\n\n* For all subjects:\n* Any condition that, in the opinion of the investigator, would make the subject's participation in the study undesirable or that would compromise compliance with the protocol\n* Persons deprived of liberty\n* Inability to understand French",{"count":118,"type":22},50,[56],"Genetic analyses conducted on patient with psychiatric disorders assessed at the expert centres resulted in the identific action of genetic variants associated with psychiatric disorders (Courtois, 2020). These data require further genetic and functional analyses. The first objective of this study is to investigate the disease-related inheritance of genetic variants in the families of individuals in whom these variants have been identified. The second objective is to explore the functional consequences of disease-associated genetic variants in patients cells and those of their relatives with and without these variants.\n\nThe present project aims to enrich existing biocollections with DNA from blood or saliva from relatives of patients identified with genetic variants. In addition, we wish to collect hair follicules from patients with identified genetic variants of interest and their family members who wish to participate in the study. These hair samples with SNA will be used to dedifferentiate the isolated cells into induced pluripotent stem cells (IPSCs), and then to differentiate them into cells expressing the gene of interest, such as neurons or astrocytes, or into more complex systems, such as brain organoids.",[100],"2024-04-22",{"date":124,"type":35},"2024-04-23",{"date":126,"type":35},"2023-03-15",{"date":128,"type":22},"2028-09-15",{"name":41,"class":42},""]