[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unipolar-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unipolar-depression":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,64,95,120,144,173,198,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100613434","phase-4-rna-editing-as-a-biomarker-of-antidepressant-response-in-unipolar-and-bipolar-depression-edit-andre-100613434",false,"NCT07266545","RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)","Inclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for the study:\n\n1. Adult females and males, aged 18-65 years\n2. Must have the capacity to understand study procedures, to comply with them for the entire length of the study, and to provide informed consent.\n3. Current major depressive episodes associated with MDD, BD-I, or BD-II, confirmed using the SCID-IV-CV. If a participant has already completed a structured diagnostic interview within the last 2 years or participated in any of the following studies and provided consent to use their information in future studies: (IRB 19-001722, IRB: 23-004500, IRB: 24-013228, IRB: 25-005856, IRB: 25-007244), those SCID results can be used for the EDIT-ANDRE study.\n4. Symptom severity score on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) \\> 10.\n5. Ability to travel for assessment visits.\n6. Negative urine pregnancy test for people of childbearing potential\n7. People of childbearing potential must be using an acceptable method of birth control during the study, such as hormonal contraception, intrauterine device, bilateral tubal ligation, partner's documented vasectomy, or complete abstinence from intercourse with childbearing potential, with barrier methods permitted only when used in combination with one of these primary methods.\n8. BD-I patients must be on stable dose of at least one mood stabilizer (i.e., lithium, valproate, or a mood-stabilizing atypical antipsychotic at least for one month) at the time of enrollment.\n\nPatients with BD-II who enroll in the study while currently taking a mood stabilizer (including lithium, valproate, or lamotrigine) must have been on a stable dose of that medication for a minimum of one month before enrollment.\n\nExclusion Criteria\n\nAll candidates meeting any of the following criteria at baseline will be excluded from study participation:\n\n1. Individuals who cannot understand English will not be enrolled because informed consent, study procedures, and interviews require comprehension of English.\n2. Inability to provide written, voluntary informed consent due to but not limited to being under conservatorship, guardianship, commitment, or currently undergoing involuntary psychiatric hospitalization.\n3. Failure to score at least 75% on a 4-item comprehension assessment related to study goals, risks, and benefits\n4. For BD-I: not having used at least one mood stabilizer (e.g., lithium, valproate, or mood-stabilizing antipsychotics) at a stable dose and within a therapeutically effective antimanic range for a minimum of one month.\n5. History of treatment-refractory depression, defined as non-response to two or more antidepressant or mood-stabilizing regimens despite adequate dose, duration, and adherence during the current episode.\n6. Participants with active suicidal ideation, defined as a MADRS item #10 score greater than 4 or a \"yes\" response to item #4 (ideation with intent) or item #5 (ideation with plan) on the C-SSRS, will be excluded\n7. A medically serious suicide attempt within the past 6 months, defined as requiring emergency department evaluation, a medical procedure, or admission to a hospital (e.g., internal medicine, cardiology, or ICU)\n8. Current use of monoamine oxidase inhibitors or use within 14 days following discontinuation of a monoamine oxidase inhibitor\n9. Presence of mixed symptoms of depression, defined as a YMRS score ≥12\n10. Current use of any of the study medications (e.g., vortioxetine, or cariprazine) at the time of enrollment (previous use of these medications is acceptable)\n11. Prior hypersensitivity reaction to any of the study medications or documented non-response to any of the study medications at the maximum therapeutic dose\n12. A history of seizure disorder\n13. Recent use of long half-life psychotropic medications, including fluoxetine (in patients with BD and MDD) and long acting injectable forms of antipsychotics (mainly in BD II and MDD) within the past 4 weeks.\n14. Active psychosis, defined as a YMRS item #8 score \\>4 or diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or schizophreniform disorder as determined by structured clinical interview\n15. Current drug or alcohol use disorder (excluding nicotine); full remission for at least 3 months is required for eligibility\n16. Positive toxicology screen for illicit substances (e.g., cocaine, methamphetamine, illegal opiates). Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.\n17. Individuals who are pregnant, lactating, trying to conceive, or not using adequate contraception (e.g., hormonal contraception, intrauterine device, tubal ligation, or condoms)\n18. Any active or unstable medical condition judged by the principal investigator to confer excessive risk\n19. Clinically significant laboratory abnormality, uncontrolled hypertension (blood pressure \\>160\u002F100 mmHg), or tachycardia (heart rate \\>110 bpm)\n20. Significant renal, hepatic, or cardiac disease; malignancy; autoimmune disease; or chronic kidney disease \\> stage IIIa (estimated GFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²)\n21. History of traumatic brain injury defined as loss of consciousness for 5 minutes and related to a trauma event\n22. Gastric bypass, specifically Roux-en-Y\n23. Clinical current diagnosis of delirium, encephalopathy, intellectual disability or cognitive disorder (mild or major neurocognitive disorder)\n24. Currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) as acute or maintenance treatment\n25. Current use of systemic steroids, chemotherapy, and radiotherapy\n26. Daily use of lorazepam (Ativan) \\>4 mg\u002Fday, or equivalent doses of other benzodiazepines (e.g., clonazepam \\>1 mg, alprazolam \\>2 mg, diazepam \\>20 mg)\n27. No access to smartphones, internet\n28. Other Axis I or II diagnoses, by clinical judgments that are the current reason for treatment evaluation or play a large part of the current symptom presentation\n29. Ongoing treatment with opioid agonists will constitute an exclusion criterion. In contrast, other ongoing treatments, such as alcohol relapse prevention agents or ADHD pharmacotherapy, will not be considered exclusion criteria, provided that no treatment initiation or significant dose adjustment has occurred within the past 4 weeks.\n\nAll candidates meeting any of the following criteria at baseline will be excluded from the Phase 2 (cariprazine add-on) of the study:\n\n1. Meeting symptomatic remission criteria based on MADRS (≤ 10).\n2. Current use of a strong or moderate CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, fluconazole, or verapamil) strong or moderate CYP3A4 inducer (e.g., carbamazepine, rifampin, phenytoin, or St. John's Wort), due to potential pharmacokinetic interactions with cariprazine.\n3. Diagnosis of BD-I with concurrent use of an antipsychotic agent as a mood stabilizer.","ALL","18 Years","65 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.",[26,27],"Unipolar Depression","Bipolar Depression","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2026-02-17",{"date":36,"type":20},"2030-12-31",{"name":38,"class":39},"Mayo Clinic","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100609578","phase-2-psilocybin-assisted-therapy-for-the-treatment-of-major-depressive-disorder-in-patients-with-non-small-cell-lung-cancer-100609578","NCT07216404","Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer","Exploring the Safety, Acceptability, and Efficacy of Psilocybin Among Non-Small Cell Lung Cancer Patients With Major Depressive Disorder: A Proof-of-Concept Trial (DREAM LUNG STUDY)","Inclusion Criteria:\n\n* Individuals diagnosed with NSCLC, confirmed by pathology report\n* Have a Karnofsky performance status \\>= 60\n* Participants receiving chemotherapy, radiation therapy, and biologic therapies may participate while receiving those therapies if they are tolerating the therapy or treatment sufficiently to allow administration of oral psilocybin and if treatments do not result in meeting any of the medical exclusion criteria outlined below\n* Moderate to severe symptoms of depression (GRID Hamilton Rating Scale for Depression \\[GRID-HAMD\\] \\> 16)\n* English-speaking\n* Over the age of 18\n* Have given written informed consent\n* Able to read\n* Be judged by study team clinicians to be at low risk for suicidality, as defined by a score of =\\\u003C 2 on the Columbia- Suicide Severity rating scale (C-SSRS) ideation subscale, 0 on the behavior subscale, and by overall clinical judgment; and\n* Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)\n\nExclusion Criteria:\n\n* GENERAL MEDICAL EXCLUSION CRITERIA\n* Participants who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; participants who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control (i.e., implants, injectables, combined oral contraceptives, progestin containing intrauterine devices \\[IUDs\\], or vasectomized partner)\n* Participants with partners of child-bearing potential who are sexually active and not practicing a highly effective means of contraception (i.e., condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository)\n* Cardiovascular conditions: Recent history of coronary artery disease or stroke, current uncontrolled angina, uncontrolled hypertension, a clinically significant electrocardiogram (ECG) abnormality as determined by a cardiologist and\u002For medical monitor (e.g., atrial fibrillation), prolonged corrected QT (QTc) interval (i.e., QTc \\> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year\n* Systolic blood pressure (SBP) \\> 139 mm HG; diastolic blood pressure (DBP) \\> 89 mm HG; heart rate (HR) \\> 90 bpm (mean values of the four or more assessments will not exceed 139 mm Hg systolic, 89 mm Hg diastolic, and\u002For 90 beats per minute)\n* Insulin-dependent diabetes\n* Non-insulin dependent diabetes if recent history of symptomatic hypoglycemia\n* Significant central nervous system (CNS) pathology. Some examples include:\n\n  * Unstable primary or secondary (e.g., metastatic) cerebral neoplasm. Stable is defined as treatment within prior 4 weeks or no immediate plans for treatment.\n  * Unstable history of seizures\n  * Cerebral aneurysm - unstable with plans for intervention or close monitoring\n  * Clinical diagnosis of dementia\n  * Clinical diagnosis of delirium\n* In the investigator's opinion, abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at screening may constitute a risk for an individual exposed to psilocybin. This includes platelets below 100,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, and creatine two times above the normal range. This also includes clinically significant abnormal electrolytes or low hemoglobin (below 10 g\u002FL)\n* Any acute condition that would, in the Investigator's judgment, place the subject at significant risk due to safety concerns or compliance with clinical study procedures (e.g., electrolyte imbalance, infection\u002Finflammation, intestinal obstruction, inability to swallow medication, etc.)\n* Under active treatment of an investigational agent in a clinical trial\n* In the judgement of the clinician, patients currently taking psychoactive medication on a regular (e.g., daily) basis (e.g., cannabis, opiates, Ritalin), other than a daily selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or bupropion (\\\u003C 300 mg daily) (Patients will not be instructed to hold prescribed psychoactive medications)\n* In the judgement of the clinician, patients who self-report or urine test positive for psychoactive medications (e.g., illicit opiates, amphetamines, cocaine) may be excluded, for example recent use by self-report but urine test negative may still be enrolled, while participants with impaired mental status will be excluded\n* PSYCHIATRIC EXCLUSION CRITERIA\n* Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or bipolar I or II disorder\n* Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol or other drug use disorder (excluding caffeine and tobacco)\n* Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition) or bipolar I or II disorder\n* Has a psychiatric condition that precludes the establishment of therapeutic rapport, as evidenced by long-term patterns of unstable relationships, a history of significant stress-related paranoia, and identity disturbances\n* History of a medically significant suicide attempt as determined by the study team and principal investigator (PI)",{"count":49,"type":20},10,[51],"PHASE2","This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.",[54,26],"Lung Non-Small Cell Carcinoma","2026-05-11",{"date":57,"type":32},"2026-05-14",{"date":59,"type":32},"2026-01-01",{"date":61,"type":20},"2027-10-31",{"name":63,"class":39},"Alan Davis",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":40},"100587895","effect-of-tao-calligraphy-meditation-and-energized-water-on-depression-100587895","NCT06934330","Effect of Tao Calligraphy Meditation and Energized Water on Depression","Effect of Tao Calligraphy Meditation and Energized Water on Depression Randomized Control Cross-over Study","Inclusion Criteria:\n\n* Age 19 and over with a primary diagnosis as one Unipolar depression according to International Classification of Diseases (ICD)-10 criteria is present and diagnosed by a licensed physician.\n* Willingness and ability to comply with data collection requirements\n* Submission of required documentation before entering the study, including informed consent and consent to release of information\n* Willingness to allow their data to be used for research purposes and published as deemed fit (while conforming to all applicable privacy laws) by Sha Research Foundation\n* Willingness to practice the daily mindfulness practices for at least 30 minutes and follow the study protocol\n\nExclusion Criteria:\n\n* Not meeting any of the inclusion criteria\n* Bipolar disorders, schizophrenia (psychosis)\n* Treatment with highly potent neuroleptics\n* Unwillingness to participate in data gathering\n* Unable to follow the practice regimen, including the daily individual mindfulness practices for at least 30 minutes\n* Pregnant or nursing. Participants who become pregnant during the study will be required to end their participation.\n* Serious mental disorders (e.g., schizophrenia)\n* There is no exclusion criteria placed upon potential subjects related to national origin, culture, ethnicity, race, sex, physical disability, sexual orientation, religion, or spiritual practices.","19 Years",{"count":73,"type":20},50,[75],"NA","The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness and Energized water Practice works to improve Unipolar Depression. The main questions it aims to answer are:\n\n* Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the subjective symptoms of Unipolar Depression in adults?\n* Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the clinical symptoms and signs of Unipolar Depression in adults?\n* Will any improvement in the John Ware's SF-36 Quality of Life questionnaire, in the Patient Health Questionnaire (PHQ) -9 and in the Beckman Anxiety Inventory (BAI) -21 in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness and energized water practices to their values at six weeks of practice and control groups.\n\nParticipants will:\n\n* be randomized into practice and control groups\n* complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 6-weeks time point, and at the 12-weeks time point\n* practice the mindfulness techniques with Tao Calligraphy for a minimum of thirty minutes daily and energized water practice for a minimum of five minutes daily.",[26],[26,79,80,81,82,83,84,85],"Well-being","SF 36 Quality of life questionnaire","PHQ-9 questionnaire","Tao Calligraphy","Healing Art","Chinese Calligraphy","BAI-21 Beckman Anxiety Inventory","2026-04-22",{"date":88,"type":32},"2026-04-28",{"date":90,"type":32},"2022-02-10",{"date":92,"type":20},"2027-01-10",{"name":94,"class":39},"Sha Research Foundation",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":40},"100552392","cognitive-enhancement-in-unipolar-depression-with-yoga-100552392","NCT06472492","Cognitive Enhancement in Unipolar Depression With Yoga","A Randomized Control Trial Involving Yoga Intervention for Cognitive Enhancement in Persons With Remitted Unipolar Depression","Inclusion Criteria:\n\n* Age more than 18years and less than 60 years\n* H\u002Fo at least one depressive episode which is under remission and at the time of examination and throughout the study duration,\n* Informed Consent\n\nExclusion Criteria:\n\n* Comorbid Psychosis, OCD, Bipolar disorder\n* Comorbid ADHD, IDD\n* Comorbid substance dependence (except tobacco)\n* Comorbid major or minor cognitive impairment,\n* Bi temporal ECT within 6 months\n* Past yoga practice - regularly for 1 month within 3 months Pregnancy","60 Years",{"count":104,"type":20},32,[75],"It is evident from recent studies that cognitive deficits persist even after remission of depressive episode. Hence, in this study, the investigators would like to see whether specific Yoga practice will help in enhancing cognitive abilities in this population.",[26],[109,110],"Unipolar depression","Yoga","2026-03-23",{"date":113,"type":32},"2026-03-27",{"date":115,"type":32},"2024-05-17",{"date":117,"type":20},"2027-06-30",{"name":119,"class":39},"University of Pittsburgh",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":40},"100483059","phase-1-enoxolone-in-major-depression---biomarker-outcome-relationship-100483059","NCT05570110","Enoxolone in Major Depression - Biomarker-outcome Relationship","Double-blind Randomized Placebo Controlled Study on the Effect of Enoxolone ( 11-beta Hydroxysteroid-dehydrogenase Type 2 Inhibitor) on the RAAS, Autonomic and Imaging Biomarkers and the Outcome of Depression","Inclusion Criteria:\n\n* Unipolar Depression\n* in women: Contraceptive means\n\nExclusion Criteria:\n\n* Schizophrenic and delusional disorders\n* Neurological diseases in which central nervous system involvement is known, such as epilepsies, storage diseases; severe mental retardation\n* Internistic diseases of moderate or higher severity, which may make participation in the study risky from a clinical point of view. In particular, multiple systolic blood pressure (measured after at least 5 min supine position) of \\> 145 mm Hg as well as hypokalemia (\\\u003C 3.5 mmol\u002Fl) and clinically relevant ECG changes\n* Poorly controlled diabetes mellitus (HbA1c \\> 10)\n* Pregnancy or active desire for pregnancy for the duration of the study\n* Non-consent or inability to consent to the study\n* Treatment with the following substances: spironolactone or eplerenone; systemic glucocorticoids\n* Treatment with ketamine or electroconvulsive therapy in the last 3 months before randomization\n* Acute suicidality\n* Intolerance to licorice preparations or licorice contents.",{"count":128,"type":20},80,[130,51],"PHASE1","Many different forms of depression exist. It is difficult to predict to what treatment a given patient with depression responds. Studies demonstrate that biomarkers can help to distinguish different forms of depression. Simple markers, like aldosterone\u002Fcortisol in body fluids, blood pressure and inflammation markers , have been identified as predictors of therapy resistance in depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may imply an improved response. The current randomized placebo controlled study is assessing whether the presence of markers of therapy resistance can predict a preferential effect of enoxolone vs. placebo on clinical outcome. Secondarily, it is tested whether these markers change differentially in the treatment groups. Finally, the relationship between the change of the markers and clinical change will be assessed.",[26],[134],"Atypical depression;","2025-12-01",{"date":137,"type":32},"2025-12-08",{"date":139,"type":32},"2022-09-23",{"date":141,"type":20},"2026-06",{"name":143,"class":39},"Philipps University Marburg",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":151,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":40},"100596189","transcranial-direct-current-stimulation-for-depression-100596189","NCT07042217","Transcranial Direct Current Stimulation for Depression","A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder","Inclusion Criteria:\n\n* Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview\n* Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression\n* QIDS-SR score \\>11 on all three days of screening week (Days 1,3, 7)\n* Scored at least 17 (inclusive) on the HDRS-17 at trial entry\n* Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening\n* Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.\n\nExclusion Criteria:\n\n* Failure to respond to at least 2 antidepressant medications\n* Drug or alcohol abuse or dependence in the preceding 3 months\n* Concurrent benzodiazepine medication\n* High suicide risk assessed during clinician screening at baseline interview.\n* Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.\n* Current DSM-V-TR psychotic disorder\n* History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician\n* Metal in the cranium or skull defects\n* Implanted pump, neurostimulator, cardiac pacemaker or defibrillator\n* Skin lesions on scalp at the proposed electrode sites\n* Pregnancy","22 Years",{"count":153,"type":20},25,[75],"This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.",[26],[158,159,160,161,162],"tDCS","mindulness","tES","electrotherapy","depression","2025-11-06",{"date":165,"type":32},"2025-11-10",{"date":167,"type":32},"2025-07-01",{"date":169,"type":20},"2026-09-01",{"name":171,"class":172},"Soterix Medical","INDUSTRY",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100582196","validation-of-emodtx-as-a-digital-endpoint-for-mood-monitoring-in-adult-patients-suffering-from-unipolar-depression-100582196","NCT06860165","Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression","Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients With Unipolar Depression: An Observational Study Against Standard Depression Assessment Questionnaires","EMC2FR","Inclusion criteria:\n\n1. Outpatients diagnosed with mild to severe unipolar disorder\n2. Age ≥ 18 years old\n3. Patients willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it)\n4. Patients who read, write and understand French\n5. Patients having signed the Patient Informed Consent\n\nExclusion criteria:\n\n1. Patients hospitalized\n2. Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines\n3. Patients taking more than 75% of the maximal recommended daily dose of antipsychotics\n4. Patients taking more than 75% of the maximal recommended daily dose of neuroleptics\n5. Patients who did not respond to 10 different pharmacological treatments\n6. Patients who attempted suicide within the previous last 6 months and presenting with suicidal ideations\n7. Patient presenting with bipolar disorders\n8. Patients with a contra-indication to the device under evaluation:\n\n   * Severe depression requiring hospitalization\n   * Schizophrenic disorders according to DSM 5 classification\n   * Major neurocognitive disorders according to DSM 5 classification\n   * Illiteracy\n   * Subject hospitalized in a healthcare or social institution for reasons other than biomedical research or is deprived of freedom by administrative or judicial decision or is placed under guardianship\n9. Patients unable to read, write and understand French\n10. Patients with no access to a smartphone or a computer with an internet connection\n11. Patients who refuse to sign the Patient Informed Consent\n12. Patients already participating in another interventional clinical study",{"count":182,"type":20},98,"OBSERVATIONAL","The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care.\n\nParticipants who agree to take part in the study, during a selection visit, will be able to:\n\n1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 8-week follow-up period.\n2. Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own.\n3. At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment.\n4. The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks.\n5. In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.",[26,186,187],"Major Depressive Disorder (MDD)","Depression","2025-07-21",{"date":190,"type":32},"2025-07-22",{"date":192,"type":32},"2025-07-15",{"date":194,"type":20},"2025-12-09",{"name":196,"class":172},"Emobot",2,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":40},"100544627","effect-of-intermittent-and-continuous-theta-burst-stimulation-on-sleep-daytime-sleepiness-and-fatigue-in-depression-100544627","NCT06371352","Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression","Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression","Inclusion Criteria:\n\n* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion\n* Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).\n* The score of the Athens Insomnia Scale five or more\n* Unchanged antidepressive pharmacotherapy at least one month prior to inclusion\n\nExclusion Criteria:\n\n* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy\n* Psychotic symptoms at the time of inclusion\n* Suicidal ideations and\u002For attempts within three months prior to inclusion",{"count":206,"type":20},90,[75],"Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.",[26,210],"Bipolar Disorder",[26,210,212,213,214,215,216],"theta burst stimulation","sleep","sleepiness","fatigue","transcranial magnetic stimulation","2024-10-10",{"date":219,"type":32},"2024-10-15",{"date":221,"type":32},"2024-05-15",{"date":223,"type":20},"2027-05",{"name":225,"class":39},"Jakub Antczak",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":40},"100544061","multisite-rtms-for-mood-cognitive-impairment-and-other-symptoms-of-depression-100544061","NCT06363981","Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression","Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder","Inclusion Criteria:\n\n* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion\n* Hamilton Depression Rating Scale between between 20 and 35 points at inclusion\n* The score in the Athens Insomnia Scale eight or more\n* The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2\n* Complaining about problems with memory and concentration timely related with the onset of depression\n\nExclusion Criteria:\n\n* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy\n* Psychotic symptoms at the time of inclusion\n* Suicidal ideations and\u002For attempts within three months prior to inclusion",{"count":206,"type":20},[75],"Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.",[26,210],[162,238,239,240,241,242,243],"repetitive transcranial magnetic stimulation","dorsolateral prefrontal cortex","dorsomedial prefrontal cortex","cognitive impairment","anhedonia","sleep disorders","2024-10-09",{"date":219,"type":32},{"date":247,"type":32},"2024-05-20",{"date":249,"type":20},"2027-04",{"name":225,"class":39}]