[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-chronic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100625429","virtual-reality-based-mindfulness-as-an-adjunct-to-treatment-as-usual-in-treatment-resistant-depression-100625429",false,"NCT07422519","Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression","A Pilot Randomised Controlled Study Evaluating the Efficacy and Tolerability of Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression","Inclusion Criteria:\n\n* Age between 18 and 74 years, inclusive\n* Diagnosis of treatment-resistant Major Depressive Disorder (MDD), single or recurrent episode, in accordance with DSM-5 diagnostic criteria.\n* Inadequate response to two or more oral antidepressants during the current depressive episode\n* Inadequate response to at least one pharmacological combination or augmentation strategy\n* Ability and willingness to provide written informed consent for participation and data collection\n\nExclusion Criteria:\n\n* Presence of any contraindication to esketamine administration according to the approved product label\n* Current participation in another interventional clinical study involving antidepressant medication\n* Any medical, psychiatric, or other condition that, in the opinion of the investigator, could: (a) compromise participant safety or well-being, or (b) interfere with, limit, or confound study assessments or outcomes","ALL","18 Years","74 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary aim of this study is to evaluate the efficacy and tolerability of a combined Virtual Reality (VR)-based mindfulness intervention and pharmacological treatment compared with pharmacological treatment alone in reducing depressive symptoms in patients with Treatment-Resistant Depression (TRD).\n\nSecondary questions this study aims to address include:\n\n1. Does the combined intervention lead to changes in inflammatory blood parameters compared with pharmacological treatment alone?\n2. Does the addition of a VR-based mindfulness intervention prolong remission of depressive symptoms six months after treatment completion?\n3. Is the combined treatment with mindfulness and esketamine well-tolerated, and how does its adverse effect profile compare with esketamine treatment alone?\n4. Is there an association between changes in mindfulness trait levels, assessed using the FFMQ-SF, and reductions in depressive symptom severity?\n\nParticipants will be recruited from a Treatment-Resistant Depression Programme and randomly assigned to receive either VR-based mindfulness intervention in addition to treatment as usual or treatment as usual alone. The mindfulness intervention will last one month and include a total of 8 sessions. All participants will undergo comprehensive assessments at baseline and at predefined follow-up time points to evaluate clinical outcomes, inflammatory markers, tolerability, and remission duration.",[27,28,29,30],"Depression - Major Depressive Disorder","Depression Disorder","Depression Chronic","Treatment-Resistant Major Depressive Disorder",[32,33,34,35,36],"Treatment-Resistant Depression","Major Depressive Disorder","Mindfulness-Based Intervention","Virtual Reality","Esketamine","RECRUITING","2026-02-25",{"date":40,"type":41},"2026-02-27","ACTUAL",{"date":43,"type":41},"2025-09-18",{"date":45,"type":21},"2026-12-15",{"name":47,"class":48},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100599323","comparing-the-efficacy-of-heated-yoga-and-sauna-as-a-treatment-for-depression-100599323","NCT07082998","Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression","Subject Characteristics\n\nInclusion Criteria:\n\n1. adults (18-65 years old)\n2. Ability to provide informed consent\n3. English language proficiency\n4. PHQ-9 score \\> 10, indicating at least moderate depressive symptoms 21\n5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\\*\n6. Individuals of childbearing potential must use an acceptable form of birth control\n7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study\n8. Must be able to access mindfulness app on a device (i.e., smartphone, iPad, etc.)\n9. Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant\n2. Breast feeding\n3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)\n4. Active eating disorders or substance use disorders within the past 12 months, as per the MINI\n5. Primary OCD or PTSD, as per the MINI\n6. History of bipolar disorder, psychotic disorders, as per the MINI\n7. ≥25% drop in PHQ-9 score from screen to baseline\n8. Under the influence or withdrawal of drugs or alcohol\n9. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the PI or designee)\n10. have had a bone fracture or joint surgery in the past 6 months\n11. not able to walk freely or without difficulty\n12. any serious, unstable medical condition as determined by the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)\n13. participants must have a healthcare provider who they could contact if they needed medical care, such as a primary care doctor, a counselor, a psychiatrist, a nurse practitioner, or a clinic that you go to.\n14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)\n15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)\n16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)\n17. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent) diuretics, barbiturates, b-blockers, anticholinergics, current ETOH acute intoxication, reduced ability to sweat, hemophilia, pacemaker (magnets used to assemble saunas can interrupt the pacer)\n18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit\n19. psychotherapy that has been initiated within the past 3 months\n20. psychiatric hospitalization within the past year\n21. diagnosed with any neurological disorders that would impact participation or make participation unsafe\n22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments\n23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)\n24. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity","65 Years",{"count":58,"type":21},120,[24],"This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms",[62,27,28,29,63,64],"Depression Disorders","Depression","Depression in Adults",[66,67,68,69,70,71,72],"depression","heated yoga","yoga","sauna","mindfulness","mindfulness app","clinical trial","2025-11-11",{"date":75,"type":41},"2025-11-13",{"date":77,"type":41},"2025-09-12",{"date":79,"type":21},"2027-07-31",{"name":81,"class":48},"Massachusetts General Hospital",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":49},"100609240","evaluation-of-dalia-solution-for-depressed-patient-100609240","NCT07211984","Evaluation of Dalia Solution For Depressed Patient","Evaluation of the Clinical and Organizational Impact of the Digital Medical Device Dalia in the Management of Depression","DaliaMonitorin","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with a diagnosis of depressive episode, as defined by ICD-11, and with a PHQ-9 score ≥ 15 confirmed by a psychiatrist or general practitioner\n* Patient receiving a first antidepressant treatment (treatment-naïve) OR having had a modification of antidepressant treatment in the two weeks prior to inclusion\n* Patient equipped with a smartphone or a computer or a tablet with internet access\n* Patient affiliated to a health insurance scheme\n* Patient able to read and understand French\n* Patient having signed informed consent\n\nExclusion Criteria:\n\n* Patient under non-cardioselective beta-blocker (carvedilol, labetalol, propranolol, pindolol) and beta-mimetic (salbutamol, terbutaline)\n* Patient with a pacemaker or with a known cardiac arrhythmia\n* Patient with major neurocognitive disorder (e.g., dementia) or psychotic disorders likely to compromise participation in the study\n* Patient hospitalized at the time of inclusion whose discharge is not planned within the next two weeks\n* Patient treated with esketamine\n* Patient with excessive consumption of psychoactive substances (alcohol or drugs), which may interfere with the course or follow-up of the study\n* Patient unable to wear the bracelet during the study due to dermatological conditions\n* Patient under guardianship, curatorship, or legal protection, or any other administrative or judicial measure depriving rights and freedom\n* Patient considered non-autonomous by the investigator\n* Patient already included in another interventional research study\n* Vulnerable persons referred to in Articles L.1121-5 to 8 and L.1122-1-2 of the French Public Health Code are excluded from the study","76 Years",{"count":92,"type":21},644,[24],"The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive patients. The main question it aims to answer is: the percentage of patients with clinically significant improvement at 3 months. A clinically significant improvement is defined as a decrease of at least 5 points from the initial PHQ-9 score AND\u002FOR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale",[29,96,97,98,99],"Depressed","Depressed Mood","Depression and Quality of Life","Depression Diagnosis",[63,101,102,103,104,105,106],"PHQ-9","MADRS","Depressive episode","Anxiety disorder","Antidepressant prescriptions","Smartwatch","NOT_YET_RECRUITING","2025-10-01",{"date":110,"type":41},"2025-10-08",{"date":112,"type":21},"2025-10-10",{"date":114,"type":21},"2026-03-31",{"name":116,"class":117},"Dalia Care","INDUSTRY"]