[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-severe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-severe":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,74,97],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100469500","brain-stimulation-for-severe-depression-100469500",false,"NCT05393622","Brain Stimulation for Severe Depression","Intracalvarial Prefrontal Cortical Stimulation in Treatment-Resistant Depression","Inclusion Criteria:\n\nTo be eligible for this study, a subject must meet all the following inclusion:\n\n1. Subject has a diagnosis of chronic (≥ two years) or recurrent (multiple prior episodes) depression and is currently experiencing a major depressive episode as defined by DSM V criteria.\n2. Subject meets a pre-treatment baseline threshold with MADRS score of \\>\u002F=20\n3. Subject has not had an sustained response to two or more adequately dosed antidepressant treatments from at least two different antidepressant treatment classes in the current depressive episode according to the Antidepressant Treatment History Form (ATHF) (Gaynes, 2020).\n4. The subject has completed all baseline testing to determine eligibility for the implant surgery (approximately 3 \\& 2 weeks prior to expected date for implant surgery, CT \\& MRI brain scans and cognitive testing).\n5. Female subject is not pregnant, agrees to use adequate birth control, or is not capable of becoming pregnant (e.g. post-menopausal, no uterus, ligation of fallopian tubes, surgical removal of ovaries)\n6. Subject is between the ages of 21 and 80.\n7. Subject is able to complete the evaluations needed for this study including the high resolution CT and MRI brain imaging scans.\n8. Subject is able to provide written informed consent and has signed the consent form for participation in this study.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from the study:\n\n1. The IpCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.\n2. Subject is expected to require full body magnetic resonance imaging (MRI) during the clinical study.\n3. Subject is judged by the investigator to be acutely suicidal (e.g., within the 30 days prior to the IpCS implant, the subject has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide).\n4. Subject has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria.\n5. Subject has a neurological disorder like Epilepsy, Dementia, Delirium, Amnestic disorder, and cognitive impairment.\n6. Subject has a history of brain injury that resulted in cognitive impairment.\n7. Subject has history of bony disorders (changes in bone density may impact the safe and effective use of the device as well a device implantation).\n8. Female subjects with a positive urine pregnancy test.\n9. Subject is taking a MAO inhibitor drug e.g., Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), or Tranylcypromine (Panate) that may pose risk for general anesthesia. The Coordinator will Identify MAOI drug and discuss with PI.\n10. Subject and\u002For Subject's psychiatrist DISAGREES with holding constant the subject's ongoing pharmacotherapy for 4 months following enrollment.\n11. Presence of hyperostosis frontalis interna (operationally defined, frontal bone thickening of \\>20mm), as determined by CT scan of the head, at the proposed site of the electrode implantation\n\n5.3 Prohibited Therapy During Study Period No drug is prohibited, with the exception of Monoamine oxidase inhibitors (MAOIs) if they are posing a risk for general anesthesia. If a subject presents on a MAOI, this will be brought to the PI's attention for discussion with the anesthesiologist. Subjects will follow study protocol of IpCS-D. In brief, after enrolling in the IpCS-D study, all subjects will have their ongoing pharmacotherapy held constant for four months. After the 4 months, all drugs for treating mood disorders are allowed.","ALL","21 Years","80 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull. Over time, intracalvarial cortical stimulation is intermittently activated to modulate locally and distally connected brain regions. Because of the important role played by the dorsolateral prefrontal cortex in mood regulation, the goal of this study is to apply intracalvarial prefrontal cortical stimulation (IpCS) over the dorsolateral prefrontal cortex in severely treatment-resistant depressed (TRD) patients. Per the DSM-V and Centre for Medicare and Medicaid Services (CMS) nomenclatures, TRD patients are commonly defined as those whose treatment failed to produce response or remission after 2 or more attempts of sufficient duration and treatment dose.\n\nIn the investigator's study, eligible TRD subjects will have a diagnosis of major depressive disorder with a suboptimal response to an adequate dose and duration of at least two different antidepressant treatment categories. These subjects will also have had exposure and transiently (non-durably) responded to non-invasive neurostimulation. The investigator anticipates that severely Treatment Resistant Depressed (TRD) Subjects with IpCS of the dorsolateral prefrontal cortex will show a significant decrease in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at four months post-implant when compared to baseline.\n\nThe investigator will enroll up to 20 subjects with severe refractory depression in an open trial, followed for up to one year. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure.",[27],"Depression Severe","RECRUITING","2026-04-12",{"date":31,"type":32},"2026-04-15","ACTUAL",{"date":34,"type":32},"2022-07-28",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Inner Cosmos Inc","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100537143","telehealth-behavioral-activation-for-teens-100537143","NCT06273995","Telehealth Behavioral Activation for Teens","Inclusion Criteria:\n\n1. Participants must be enrolled in the Texas Youth Depression Suicide Research Network (TX-YDSRN) Registry Study;\n2. Be between the ages of 12- 18 or currently enrolled in high school;\n3. Have a caregiver that is willing to participate in the program;\n4. Be able to commit to weekly sessions for eight weeks;\n5. Be currently experiencing depressive symptoms;\n6. Be able to participate in telehealth services within the state of Texas;\n7. Be willing to provide consent\u002Fassent (parents\u002Flegally authorized representative (LAR)\u002Fguardian or young adult participant, aged 18 or older, must be willing to provide consent; youth, aged 12-17, must be willing to provide assent);\n8. Be able to read, write and speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study;\n9. Be willing to dedicate appropriate time to complete scheduled study assessment and measures and attend intervention sessions (both parent\u002FLAR\u002Fguardian and youth)\n10. Be able to provide a reliable means of contact.\n\nExclusion Criteria:\n\n1. Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;\n2. Have an acute medical or psychological condition(s) that would result in an inability to accurately complete study requirements (e.g., neurological conditions or significant neurodevelopmental concerns);\n3. Have active psychotic or manic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and\u002For higher level of intervention;\n4. Have a parent\u002FLAR\u002Fguardian who is deemed cognitively unable to provide consent (if youth participant, aged 12-17).","12 Years","18 Years",{"count":50,"type":21},250,[24],"Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas.",[54,55,56,57,58,27],"Depression","Suicide and Self-harm","Depression in Adolescence","Depression Mild","Depression Moderate",[60,61,62],"behavioral activation","depression","adolescents","2025-07-18",{"date":65,"type":32},"2025-07-20",{"date":67,"type":32},"2024-03-01",{"date":69,"type":21},"2029-12-01",{"name":71,"class":72},"Baylor College of Medicine","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":73},"100578331","kintsugi-voice-device-pivotal-study-100578331","NCT06809907","Kintsugi Voice Device Pivotal Study","Kintsugi Voice Device SCID-5 Pivotal Study","Inclusion Criteria:\n\nAge \\>22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exercise, diet, or recreation) Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet Stated willingness to be video and audio recorded as part of the study Stated willingness to comply with all study procedures and availability for the duration of the study Functional English capacity in the home environment Availability for the duration of the study Resides in the United States at the time of consent and during completion of study\n\n\\-\n\nExclusion Criteria:\n\n* Participants with at least one of the following conditions will be excluded:\n\nAny impairment that impacts their ability to speak and\u002For use a computer to complete online surveys and\u002For a virtual clinician assessment (E.g., visual impairment, motor impairment, and\u002For hearing impairment) Any lifetime history of neurological disease that impacts their ability to speak and\u002For use a computer to complete online surveys and\u002For a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and\u002For Parkinson's Disease) Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and\u002For Traumatic Brain Injury Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia) Past or active heavy smokers (an average of \\>20 cigarettes per day) Subjects who have previously participated in any Kintsugi-sponsored study",true,"22 Years",{"count":84,"type":21},1000,"OBSERVATIONAL","A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks",[54,58,27,57],"2025-04-28",{"date":90,"type":32},"2025-04-30",{"date":92,"type":32},"2025-03-27",{"date":94,"type":21},"2025-11",{"name":96,"class":39},"Kintsugi Mindful Wellness, Inc.",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":40},"100499818","integrated-depression-care-100499818","NCT05788198","Integrated Depression Care","Integrated Depression Care Project","IDECA","Inclusion Criteria:\n\n* persons between 18-65\n* presenting to the general practitioner's office\n* with depressive symtomatology\n\nExclusion Criteria:\n\n* Severe depression warranting direct referral to specialized services\n\nInclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.","65 Years",{"count":107,"type":21},150,[24],"The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).",[57,58,27],"2024-06-05",{"date":113,"type":32},"2024-06-06",{"date":115,"type":32},"2023-04-25",{"date":117,"type":21},"2024-09-30",{"name":119,"class":72},"University Ghent"]