[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treatment-resistant-major-depressive-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treatment-resistant-major-depressive-disorder":196},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,69,104,137,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100596944","phase-2-triple-blind-randomized-clinical-trial-of-tocilizumab-vs-placebo-potential-use-of-an-il-6-antagonist-as-an-adjuvant-to-standard-treatment-for-treatment-resistant-major-depression-in-the-brazilian-public-health-system-sus-100596944",false,"NCT07052058","Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to Standard Treatment for Treatment-Resistant Major Depression in the Brazilian Public Health System (SUS)","Inclusion Criteria:\n\nAge ≥ 18 years Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling Willing to abstain from strenuous exercise for 72 hours prior to assessment Meet DSM-5\u002FMINI criteria for a diagnosis of depression resistant to at least two adequate courses of treatment at the time of eligibility assessment Baseline HDRS score of 19 or higher at Serum\u002Fplasma CRP level ≥3 mg\u002FL\n\nExclusion Criteria:\n\nDiagnosis of bipolar disorder or personality disorder History of substance use disorder in the past six months. Presence of active\u002Frecent infection (including TB, Hepatitis B, Hepatitis C, or HIV) or autoimmune disease Pregnancy or breastfeeding History of significant cardiovascular disease, recent cancer, or hematological disorders BMI \\>40 kg\u002Fm² or weight \\>100 kg Hypersensitivity to tocilizumab or any of its excipients. CRP ≥20 mg\u002FL Active liver disease or transaminase elevation \\>1.5× the upper limit of normal\n\nInclusion criteria to the 10 healthy controls recruited for comparison of inflammatory biomarkers:\n\nAge ≥ 18 No current or lifetime psychiatric diagnosis, as measured by the SRQ-20 Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling",true,"ALL","18 Years","65 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Clinical trial aimed at evaluating whether a single infusion of tocilizumab, a medication that blocks the action of an inflammatory molecule called interleukin-6 (IL-6), can reduce symptoms of treatment-resistant major depression compared to placebo in non-hospitalized patients.",[27],"Treatment-Resistant Major Depressive Disorder","NOT_YET_RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-15","ACTUAL",{"date":34,"type":21},"2026-07-01",{"date":36,"type":21},"2028-07-01",{"name":38,"class":39},"Hospital de Clinicas de Porto Alegre","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100585433","phase-1-personalized-ultrasonic-brain-stimulation-for-depression-r61-100585433","NCT06902298","Personalized Ultrasonic Brain Stimulation for Depression (R61)","Personalized Ultrasonic Brain Stimulation for Depression: A Study of Target Engagement and Mood Effects","Inclusion Criteria:\n\n1. Age 18-65, any gender.\n2. Primary diagnosis of DMS-5 major depressive disorder (MINI).\n3. Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months (MINI).\n4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \\> 10.\n5. History of at least 2 failed trials of evidence-based antidepressant medication and\u002For psychotherapy (at least one trial during the current depressive episode).\n6. Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study.\n7. For participants of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study.\n8. Capacity to provide informed consent; provision of a signed and dated consent form\n9. Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.\n10. Agrees to allow any and all forms of communication between the investigators\u002Fstudy staff and any healthcare provider who currently provides and\u002For has provided service to the patient\u002Fsubject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.\n11. Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within a 60-minute drive of the patient's residence. Subject agrees that in the event of a safety concern or event during study participation, research staff is at liberty to contact these individuals if the subject does not respond to contact attempts.\n\nExclusion Criteria:\n\n1. History of serious brain injury or other neurologic disorder.\n2. Poorly managed general medical condition.\n3. Pregnant or breast feeding.\n4. Implanted device in the head or neck.\n5. MRI intolerance or contraindication.\n6. Brain stimulation treatment such as ECT, TMS, or VNS (past month).\n7. Recent change in antidepressant treatments (past month).\n8. 8\\. Moderate-High Risk of Suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk)) and\u002For in the clinical judgement of the PI or a study psychiatrist\n9. Suicidal behavior (past year).\n10. Serious suicide attempt 33 (lifetime).\n11. Moderate-to-severe substance use disorder (MINI, past 3 months).\n12. Obsessive compulsive disorder, primary diagnosis (MINI, past month).\n13. Posttraumatic stress disorder, primary diagnosis (MINI, past month).\n14. Bipolar-spectrum disorder (MINI, lifetime).\n15. Schizophrenia-spectrum disorder (MINI, lifetime).\n16. Neurocognitive disorder (DSM-5, past year).\n17. Severe personality disorder.\n18. Clinically inappropriate for participation in the study as determined by the study team.",{"count":49,"type":21},30,[51,24],"PHASE1","This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will be delivered using a range of stimulation parameters during psychological and physiological monitoring. Individualized optimal targets will be selected using structural MRI and diffusion tractography. Brain target engagement will be evaluated using functional MRI.",[54,55,27],"Major Depressive Episode","Depression - Major Depressive Disorder",[57,58],"ultrasonic neuromodulation","low-intensity focused ultrasound","RECRUITING","2026-04-29",{"date":62,"type":32},"2026-05-01",{"date":64,"type":32},"2025-03-10",{"date":66,"type":21},"2026-11",{"name":68,"class":39},"Brian Mickey",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100636708","phase-2-ketamine-with-dialectical-behavioural-therapy-dbt-for-suicidality-in-individuals-with-treatment-resistant-depression-and-borderline-personality-disorder-ket-dbt-100636708","NCT07569198","Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)","Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)","KET-DBT","Inclusion Criteria:\n\n1. Adults between the age of 18 to 70, inclusive;\n2. Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);\n3. Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);\n4. Current MDE must be moderate to severe, as determined by the MADRS score \\>20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);\n5. No changes in pharmacotherapy for MDD\u002FBD in the last month or changes in psychotherapy in the past month;\n6. Baseline SI as shown by two consecutive MSSI scores \\> 10 two weeks apart.\n\nExclusion Criteria:\n\n1. Past or current history of a psychotic disorder as determined by clinical assessment and MINI;\n2. Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score \\> 12) and the MINI;\n3. Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;\n4. Lifetime history of ketamine use disorder or illicit ketamine use.\n5. Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).\n6. Presence of a relative or absolute contraindication to ketamine or midazolam, including a drug allergy, lifetime history of stroke, uncontrolled hypertension (Systolic BP \\> 160 or Diastolic BP \\> 100), low or labile blood pressure (Systolic BP \\\u003C 100 or Diastolic BP \\\u003C 60), recent (within the past 6 months) myocardial infarction, severe coronary artery disease (ascertained through participant's medical history), or moderate to severe renal (GFR scores ≤ 44) or hepatic impairment (A Child-Pugh score of ≥ 7);\n7. Currently pregnant or breastfeeding or planning on getting pregnant within the first two months of the trial or planning on getting someone else pregnant within the first two months of trial. Participants who are sexually active must agree to use a highly effective contraceptive method (please see exhaustive list in Section 3.6.1);\n8. Current use of prohibited concomitant medications, including other forms of ketamine or esketamine, high dose daily benzodiazepines (greater than 4 mg lorazepam equivalent daily) or monoamine oxidase inhibitors;\n9. Currently engaged (or completed within the past year) in DBT treatment. NOTE: Individuals who have received only DBT skills training in the past year will be considered eligible to participate;\n10. Those engaged in other forms of psychotherapy must be willing to discontinue for the duration of the 6-month DBT intervention (standard for DBT). There should be no changes in psychotherapy 30 days prior to baseline (i.e., Screening Visit 2).","70 Years",{"count":79,"type":21},120,[24],"The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is:\n\nDoes IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?\n\nResearchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity.\n\nParticipants will:\n\n* Complete six infusions of either IV ketamine or IV midazolam\n* Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial)\n* Visit the hospital for scheduled in-person visits\n* Join a call or videocall for scheduled remote visits\n* Complete a variety of different mood, cognitive and behavioral assessments",[83,27,84,85,86,87,88],"Borderline Personality Disorder (BPD)","Treatment-resistant Bipolar Depression","Major Depressive Disorder (MDD)","Bipolar Disorder (BD)","Bipolar Disorder I or II","Suicidal Ideation",[90,91,92,93,86,85,94],"Dialectical Behavioural Therapy (DBT)","ketamine","Borderline Personality Disorder","Treatment-Resistant Depression","Suicidality","2026-04-28",{"date":97,"type":32},"2026-05-06",{"date":99,"type":21},"2026-06-01",{"date":101,"type":21},"2029-08",{"name":103,"class":39},"Joshua Rosenblat",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100621662","phase-2-understanding-music-and-mindfulness-preferences-in-psilocybin-assisted-psychotherapy-100621662","NCT07373535","Understanding Music and Mindfulness Preferences in Psilocybin-Assisted Psychotherapy","Toward Patient-Tailored Care for Treatment-Resistant Depression: A Pilot Patient-Preference Clinical Trial of Music and Mindfulness in Psilocybin-Assisted Psychotherapy","PPP","Inclusion Criteria:\n\n* At least 21 years of age at screening.\n* Diagnosis of unipolar Major Depressive Disorder (MDD) according to diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), confirmed by a study psychiatrist using the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.\n* Failure to achieve remission from at least two trials of evidence-based oral antidepressants, in the current episode, of adequate dose and duration.\n* Moderate to severe symptoms according to the clinician-administered Montgomery-Åsberg Depression Rating Scale (MADRS): total score ≥ 25 on screening.\n* Active follow-up in psychiatry.\n* Able and willing to give informed consent to participate in the study, and for the study clinicians to communicate with their psychiatrist throughout the intervention phase of the study.\n* Available and willing to comply with all study assessments.\n* Stable psychotropic medications for at least eight weeks at the time of enrollment.\n* Able to read and understand French and\u002For English.\n* Has at least one identified support person, including a friend or family member, who agrees to accompany patient home (or to an otherwise safe destination) following the psilocybin treatment sessions.\n\nExclusion Criteria:\n\n* Deemed to be greater than low risk of suicide on psychiatric interview.\n* Currently or previously diagnosed with any of the following, according to available information and psychiatric interview: major depression with psychotic features, schizophrenia spectrum or other psychotic disorders, and\u002For bipolar affective disorder I or related disorders.\n* Current or past diagnosis of personality disorder deemed to pose a significant risk for safety and\u002For trial compliance.\n* Family history (first-degree relative) of psychosis.\n* Current or recent (\\\u003C six months) substance use disorder, except for tobacco use disorder.\n* Deemed to be greater than low risk of future substance use disorder.\n* Currently receiving and deemed to be unsuitable, on psychiatric interview, to discontinue medications with significant serotonin 2A antagonism (e.g., trazodone) or known potential for serious interactions with psilocybin including serotonin syndrome (e.g., monoamine oxidase inhibitors), seizures (e.g., lithium), or which may affect psilocybin pharmacokinetics (e.g. UDG modulators, aldehyde dehydrogenase inhibitors).\n* Unwilling or unable to maintain current psychotropic medications throughout the treatment phase of the trial.\n* Currently undergoing psychotherapy that will not remain stable for the duration of the study or was initiated within 21 days of baseline.\n* Prior use of serotonergic psychedelics in the past year and\u002For more than five life-time uses.\n* Use of any serotonergic psychedelic or ketamine, or any other illicit substance during the active treatment period of the trial.\n* Medical contraindications:\n* Current or past history of seizure disorder with the exception of infantile febrile seizures.\n* Significant cardiovascular disease including uncontrolled blood pressure (\\> 140\u002F90mmHg), clinically significant arrhythmia, heart failure, coronary artery disease, history of ischemic or hemorrhagic stroke, or history of myocardial infarction.\n* Abnormal and clinically significant results on the physical examination, laboratory investigations, or ECG at screening.\n* Any other clinically significant illness deemed to pose significant health risks for participation in the study.\n* Pregnant or lactating.\n* For women of child-bearing potential, defined as all women physiologically capable of becoming pregnant: unwilling to utilize highly effective contraceptive during the 10-week active intervention (e.g., oral contraceptive). Acceptable forms of highly effective contraception methods include: a. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; b. Male\u002Ffemale sterilization defined as: 1) Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed and documented by follow up hormone level assessment; 2) Male sterilization of the sole partner (at least 6 months prior to screening) of a female patient on the study. c. A combination of any two of the following (i+ii or i+iii or ii+iii):\n\n  i) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository ii) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception iii) Placement of an intrauterine device (IUD) or intrauterine system (IUS).\n* Men unwilling to not attempt to father a child or not donate sperm, while participating the active treatment period of this study.","21 Years",{"count":114,"type":21},16,[24],"The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how people respond to psilocybin treatment.\n\nThe main questions it aims to answer are:\n\n* Is it feasible to conduct a patient-preference randomized trial of psilocybin-assisted psychotherapy?\n* Does receiving a preferred psychotherapy style improve treatment experiences or outcomes?\n* How do music-centered and mindfulness-centered PAP approaches compare in their effects on improving mood and well-being?\n\nResearchers will compare music-centered PAP to mindfulness-centered PAP to see if aligning psychotherapy with individual preferences is a practical and potentially beneficial approach for improving treatment efficacy and tolerability.\n\nParticipants will:\n\n* Be adults with treatment-resistant depression\n* Receive two 25 mg psilocybin (PEX010, Filament Health) sessions, spaced four weeks apart\n* Experience one session with music-centered psychotherapy and one with mindfulness-centered psychotherapy\n* Before treatment, rate their preference for the two psychotherapy approaches\n* Be randomly assigned to receive their preferred or non-preferred approach first, followed by the other\n* Complete preparation and integration sessions before and after each psilocybin session\n\nThis feasibility trial will also collect information on participants' cultural and personal factors influencing psychotherapy preferences using a modified Cultural Formulation Interview, and explore physiological measures of therapeutic alliance, an important factor in psychotherapy outcomes.",[27],[119,120,121,122,123,124,125,126],"Psilocybin","Clinical Trial","Depressive Disorder, Treatment-Resistant","Music","Mindfulness","Feasibility","Culture","Patient preference","2026-04-21",{"date":129,"type":32},"2026-04-22",{"date":131,"type":21},"2026-05",{"date":133,"type":21},"2028-12",{"name":135,"class":39},"Kyle Greenway",2,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":40},"100625429","virtual-reality-based-mindfulness-as-an-adjunct-to-treatment-as-usual-in-treatment-resistant-depression-100625429","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","74 Years",{"count":49,"type":21},[147],"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.",[55,150,151,27],"Depression Disorder","Depression Chronic",[93,153,154,155,156],"Major Depressive Disorder","Mindfulness-Based Intervention","Virtual Reality","Esketamine","2026-02-25",{"date":159,"type":32},"2026-02-27",{"date":161,"type":32},"2025-09-18",{"date":163,"type":21},"2026-12-15",{"name":165,"class":39},"Hospital Universitari Vall d'Hebron Research Institute",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":40},"100572347","digital-interventions-for-adults-with-treatment-resistant-depression-a-pilot-study-100572347","NCT06732089","Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study","Determining the Feasibility of Digital Interventions for Adults with Treatment-Resistant Depression","Inclusion Criteria:\n\n* Adults (aged 18+) who are capable of giving informed consent\n* Patients meeting diagnostic criteria for major depressive disorder (MDD) without psychotic symptoms according to the DSM-5\n* Currently experiencing a major depressive episode (MDE)\n* Montgomery-Asperg Depression Rating Scale (MADRS) score greater than 20 at screening\n* Patients meeting criteria for treatment-resistant depression (TRD): failure of 2 or more adequate trials of antidepressant therapy of adequate dose and duration during the current episode\n* Enrollment in one of the treatment modalities (rTMS, IVK, or ECT) at the Interventional Psychiatry Program at St. Michael's Hospital, Unity Health Toronto\n* Ownership of a smartphone (for participants using wearable devices)\n\nExclusion Criteria:\n\n* Individuals without Internet access (required to access study platforms)\n* Medication changes, aside from the treatment received through the IPP, one month (28 days) before screening, or during the entire duration of treatment (variable based on treatment arm)\n* Participants who do not speak English fluently enough to successfully communicate study information, answer questions accurately, and\u002For obtain informed consent",{"count":174,"type":21},200,"OBSERVATIONAL","The goal of this observational study is to learn about remote mental health monitoring technology for adults with treatment-resistant depression. The main question it aims to answer is: are digital mental health monitoring tools (an electronic data capture platform and wearable device (e.g., smartwatch or smart-ring)) feasible to implement alongside clinical treatment for depression? The secondary aim of this study is to inform preliminary clinical parameters for larger, definitive studies.\n\nParticipants receiving neuropsychiatric treatment (repetitive transcranial magnetic stimulation, intravenous ketamine, or electroconvulsive therapy) as part of their regular medical care for treatment-resistant depression in the Interventional Psychiatry Program will have their clinical assessment data entered into a digital platform and will wear an accessory-based wearable device for the duration of treatment.",[85,54,27],[179,180,181,182,183,184,185,186],"pilot study","digital health monitoring","wearable device","remote measurement-based care","treatment-resistant depression","observational study","feasibility study","electronic data capture","2024-12-09",{"date":189,"type":32},"2024-12-13",{"date":191,"type":21},"2024-12-16",{"date":193,"type":21},"2026-12",{"name":195,"class":39},"Unity Health Toronto","Treatment Resistant Major Depressive Disorder"]