[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depressive-sympotoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depressive-sympotoms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642801","phase-3-efficacy-in-relapse-prevention-psilocybin-in-alcohol-use-disorder-with-depressive-symptoms-100642801",false,"NCT07638553","Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms","ERPPAD","Inclusion Criteria:\n\n* Confirmed DSM-5 diagnosis of severe AUD.\n* Scale BDI-II ((Beck Depression Inventory) ≥14\n* The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient unable to give informed consent.\n* Participants planning to donate sperm within three months of psilocybin administration\n* Positive pregnancy test at inclusion for participants of childbearing age.\n* Patient who is pregnant, breastfeeding, or wishing to become pregnant during participation in the study.\n* Any use of classical psychedelic in the last year\n* Other current substance use disorder (except tobacco)\n* Diagnosed schizophrenic or bipolar disorder\n* High emotional lability (clinician-judged)\n* On antipsychotics treatment that may interfere with psilocybin.\n* Need for monoamine oxidase inhibitor (MAOI) treatment, which may interfere with psilocybin.\n* Severe suicidal ideation (high risk on the Columbia scale)\n* 1st degree family member with a diagnosed psychotic disorder\n* Severe cognitive impairment (clinician-judged)\n* CIWA-AR \\> 8\n* Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function; coronary artery disease; history of arrhythmia; Abnormal QT interval prolongation (QTc \\> 470 ms for women and \\>450 ms for men); heart failure; uncontrolled hypertension (greater than 165\u002F95 mmHg at screening); history of stroke; severe asthma; hyperthyroidism; narrow-angle glaucoma; stenosing gastroduodenal ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy or bladder neck obstruction; uncontrolled type I or type II diabetes, or a history of ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness.","ALL","18 Years",{"count":19,"type":20},172,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants.\n\nThe Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \\[0.16-1.65\\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.",[26,27,28],"Alcohol Use Disorder","Depressive Sympotoms","Psilocybin","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":30,"type":33},{"date":36,"type":20},"2030-06",{"name":38,"class":39},"Centre Hospitalier Universitaire de Nīmes","OTHER",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100633776","effects-of-a-salutogenic-strength-based-social-robot-assisted-intervention-on-the-depressive-symptoms-and-sense-of-coherence-of-family-caregivers-of-persons-with-dementia-100633776","NCT07531082","Effects of a Salutogenic Strength-based Social Robot-assisted Intervention on the Depressive Symptoms and Sense of Coherence of Family Caregivers of Persons With Dementia","social robot","Inclusion Criteria:\n\n* those aged 18 years or older;\n* family caregivers of PwD who had been clinically diagnosed;\n* are living in the same household as the PwD;\n* providing daily caregiving for ≥ 4 hours \u002Fday;\n* have mild-to-moderate depressive symptoms (PHQ-9 score of 5-14) (Yu et al., 2012); and\n* are able to speak Cantonese.\n\nExclusion Criteria:\n\n* those who have been diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression in an acute stage;\n* those with a visual or hearing impairment that would interfere with the use of a robot;\n* those currently using a social robot at home; and\n* who have limited access to electricity at home.",{"count":49,"type":20},148,[51],"NA","Family caregivers of persons with dementia (PwD) are well known to be \"invisible patients.\" Existing studies have suggested that sense of coherence (SOC), a core inner strength, could be a protective factor against depression among family caregivers of PwD. However, few interventions are available to enhance the SOC and thereby the emotional and psychological health of this population. While in-home social robots are viewed as a useful addition to caring for PwD, the use of social robots with family caregivers as the primary audience are vastly under-investigated. In response, the investigators have developed a strength-based, robot-assisted intervention based on Antonovsky's theory of saluotogenesis for family caregivers of PwD. The feasibility, acceptability, and preliminary effects of the robot on family caregivers of PwD have been confirmed, with recommendations for examining its applicability among this population in a full trial.\n\nThis study aims to examine the effects of a salutogenic strength-based, robot-assisted intervention on improving depressive symptoms in family caregivers of PwD. This is a mixed-methods study, including a prospective, single-blinded, two-arm parallel randomized controlled trial and semi-structured individual interviews. A group of 148 family caregivers of PwD will be randomized to the intervention group (IG) or the control group (CG), who will receive reading materials on dementia care weekly. Each IG participant will engage with a robot integrated with an AI-powered chatbot at home for 6 weeks. Individual interviews will be conducted at week-6. Purposive sampling will be used to ensure diversity among the participants. Descriptive statistics, t-test and\u002For Chi square test, generalized estimating equation (GEE), linear regression and thematic analysis will be used.\n\nPrimary hypothesis: Participants in the intervention group (IG) will report a greater improvement in depressive symptoms than the control group (CG) immediately postintervention at 6 weeks (T1), 1-month (T2) and 3-month (T3) after completing the intervention.\n\nSecondary hypothesis: 1) Participants in the IG will report a greater improvement in SOC, perceived caregiving burden, coping, and caregiving self-efficacy than the CG at T1, T2, and T3; 2) The frequency of engaging with specific robot features is associated with improved depressive symptoms, SOC, caregiving burden, coping, and caregiving self-efficacy.\n\nThe findings may: 1) advance the understanding of the application of the salutogenesis theory to robotic technology, 2) boost the inner strength of family caregivers to maintain their emotional and psychological health in stressful situations, and provide a new paradigm to strengthen the informal care system.",[27],"NOT_YET_RECRUITING","2026-04-09",{"date":57,"type":33},"2026-04-15",{"date":59,"type":20},"2026-06-01",{"date":61,"type":20},"2029-12-30",{"name":63,"class":39},"The Hong Kong Polytechnic University"]