[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-depression":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100526241","phase-2-psilocybin-rtms-for-treatment-resistant-depression-100526241",false,"NCT06132178","Psilocybin rTMS for Treatment Resistant Depression","Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder","PSILOBSD","Inclusion Criteria:\n\n1. Adults, ages 22-65.\n2. English language comprehension suitable to understand experimenter instructions and to communicate to study personnel\u002Fstaff reasonably easily.\n3. Current major depressive episode (without psychotic features), either as part of recurrent major depressive disorder (MDD) or single episode MDD with current episode present for at least the past 3 months (as determined by the Structured Clinical Interview for DSM-5; SCID-5).\n4. Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater at baseline assessment (at least moderate severity).\n5. 1\\. Treatment-resistant MDD, defined as either: a) failure to respond to an adequate dose and duration of two or more pharmacological treatments, with at least one failed medication trial occurring in the current major depressive episode; or b) failure to respond to an adequate dose and duration of 2 or more pharmacological treatments of different pharmacological classes in one or more past major depressive episodes. Adequate treatment dose and duration will be determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). Augmentation, where an add-on medication is used, will be counted as a second treatment, provided it is approved as an adjunctive treatment of MDD in the country where prescribed.\n6. Willingness and ability to attend daily, full-day visits to the research site for a period of \\~2 weeks and to participate in all study procedures (clinical assessments, treatments, and neurobiological assessments).\n7. If currently taking an antidepressant medication (an SSRI, SNRI, or atypical antidepressant), antipsychotic, and\u002For other augmenting medication (e.g., lithium), willingness to discontinue medication(s) over a 2-8 week period with the assistance of study staff and maintain at least a 2-5 week period (5-week period for fluoxetine) off of medications prior to the baseline visit AND willingness to remain off medications for a period of 1 month following the end of the treatment course (approximately 6-8 weeks after the baseline visit).\n\nExclusion Criteria:\n\n1. Prior history or current diagnosis of a psychotic disorder (including MDD with psychotic features), bipolar disorder, or personality disorder (based on medical history, clinician judgement, SCID-5 and\u002For SCID for Personality Disorders).\n2. Current diagnosis of posttraumatic stress disorder, acute stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, or alcohol or substance-use disorder.\n3. Having met criteria for an alcohol or substance-use disorder within the past year.\n4. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode.\n5. Any prior rTMS treatment (10Hz, 5Hz, 1Hz, or conventional intermittent theta burst).\n6. Current participation in an evidence-based psychotherapy for major depression (e.g., cognitive behavioral therapy, behavioral activation). Ongoing supportive psychotherapy is allowable if maintained at the same frequency throughout the duration of the short-term follow-up clinical endpoint (1 month after treatment cessation) of the study and if no recent change in therapy type or frequency for 1 month prior to enrollment.\n7. Exhibiting significant suicide risk within the past 12 months, at screening, or at baseline, as evidenced by: a) suicidal ideation with some intent to act but no specific plan (item #4 from the Columbia Suicide Severity Rating Scale57; C-SSRS); b) suicidal ideation with intent to act and a specific plan (item #5 from the C-SSRS); c) suicide attempt or non-suicidal self-injury requiring medical attention in the past 12 months; or d) self-report of significant suicidal ideation with intent or significant non-suicidal self-injury during screening or baseline clinical interview.\n8. Major depressive episode that is secondary to a medication or a general medical condition, as judged by investigators.\n9. Any other factors, such as major medical conditions, unstable housing or threatening life circumstances, erratic behavior, etc. that are judged by the investigators to be a significant barrier to participation in the study protocol and\u002For to establishing therapeutic rapport necessary for safe administration of psilocybin.\n10. Prior past-year ingestion of a serotonergic psychedelic, e.g., psilocybin, LSD, mescaline, dimethyltryptamine, etc. or more than 5 lifetime ingestions of a serotonergic psychedelic on separate occasions.\n11. Participant unwillingness to not ingest or use additional serotonergic psychedelics outside the context of study procedures for the duration of the study follow-up period (12 months).\n12. Ferrous metal, metallic implants, or implanted medical devices that would preclude administration of rTMS and\u002For participation in MRI procedures, including but not limited to: cochlear implants, implanted brain stimulators, aneurysm clips.\n13. Past history of seizures or epilepsy (rTMS risk).\n14. Neurological disorder, including epilepsy, stroke, or history of brain surgery.\n15. Past penetrating brain injury or any head injury resulting in a loss of consciousness for 30 minutes or more or post-concussive symptoms for more than seven days following a head injury.\n16. Head injury in the past two months, regardless of severity.\n17. Currently pregnant and\u002For nursing or about to become pregnant. A positive urine pregnancy test at screening and\u002For baseline will lead to participant exclusion from the study.\n18. Engagement in sexual intercourse which could result in pregnancy without use of a highly effective contraceptive method throughout participation in the study and for at least three months after COMP360 (psilocybin) administration.\n19. Severe claustrophobia (prohibiting MRI acquisition).\n20. Uncontrolled hypertension (resting blood pressure \\> 140\u002F90 mm hg).\n21. Uncontrolled thyroid disease as indicated by unstable thyroid hormone dosage \\\u003C 3 months prior to screening, or abnormal and clinically significant thyroxine (FT4) levels (a free FT4 measurement will be conducted for all participants with an out-of-range thyroid-stimulating hormone \\[TSH\\] value irrespective of thyroid history).\n22. Lifetime history of cardiomyopathy, stroke, heart disease, heart attack, tachycardia, elongated QT-interval corrected by Friderichia (\\> 450ms for men and \\> 470ms for women); clinically significant cardiac arrhythmia within 1 year of study entry; and\u002For abnormal electrocardiogram on study entry.\n23. Type I diabetes mellitus or uncontrolled Type II diabetes mellitus (defined by hemoglobin A1c \\> 8% at screening) or a history of diabetic ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness (\\\u003C 3 months prior to signing of consent form).\n24. Positive urine drug screening for drugs of abuse at screening and\u002For baseline will trigger a review with participant and assessment for eligibility based on pattern of use and willingness to abstain in conjunction with medical monitor and investigative team.\n25. Clinically-significant results from physical examination, blood test, urine test, vital signs, or ECG at screening and\u002For baseline.\n26. Current enrollment in another interventional study or participation within such a study within 6 months of screening.\n27. Self-reported hypersensitivity to psilocybin or another serotonergic psychedelic.","ALL","22 Years","65 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.",[28,29,30,31,32],"Treatment Resistant Depression","MDD","Major Depressive Disorder","Recurrent Depression","Depression","RECRUITING","2025-11-20",{"date":36,"type":37},"2025-11-26","ACTUAL",{"date":39,"type":37},"2025-01-10",{"date":41,"type":22},"2030-12-31",{"name":43,"class":44},"University of Texas at Austin","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100595551","neuro-computational-study-of-thymic-fluctuations-in-mood-disorders-100595551","NCT07033923","Neuro-computational Study of Thymic Fluctuations in Mood Disorders","Neuro-computational Study of Thymic Fluctuations in Mood Disorders - MOODELING","MOODELING","Inclusion Criteria:\n\nCommon between groups (DD, BD, control and GP):\n\n* Having given informed and written consent\n* Being covered by social security\n\nFor patients with depressive disorder (DD):\n\n* Having been diagnosed with characterized depressive episode (F32, F33, F34) according to the ICD-10, by a psychiatrist, or having presented this diagnosis during the past 12 months\n\nFor patients with bipolar disorder (BD):\n\n* Presenting a diagnosis of bipolar mood disorder (F31) according to ICD-10, by a psychiatrist\n* Having presented a mood episode (F31.0 - F31.6) diagnosed during the past 12 months by a psychiatrist\n\nExclusion Criteria:\n\nCommon between groups (DD, BD, control and GP):\n\n* Inability to carry out daily monitoring on mobile application for 12 months\n* legal protection measure (guardianship or curatorship)\n\nFor control group:\n\n* Current diagnosis of psychiatric disorder in ICD-10 (F20-F98) or prescription of psychotropic treatment\n* History of depression (F32)\n* Syndrome of dependence on a psychoactive substance other than tobacco\n* Neurological history (in particular history of stroke, coma, epilepsy, neuro- inflammatory, or neuro-degenerative disease)\n* Inability to carry out daily monitoring on mobile application for 12 months\n\nFor patients and healthy volunteers for whom an MRI (without injection of contrast agent) is proposed\n\n* Contraindication to MRI: cardiac pacemaker not compatible with MRI, heart valve implant, implant or metallic foreign body\n* Pregnant woman (at the time of MRI)",true,"18 Years",{"count":57,"type":22},588,[59],"NA","Depression and bipolar disorder are frequent, debilitating conditions. Both are thought to be primarily caused by an impaired regulation of mood, which is why they are sometimes referred to as \"mood disorders\". However, the biological basis of mood remains poorly understood, which is a major limitation for the development of new treatments.\n\nRecent work that combines neuroscience with mathematical models are promising to better understand mood and to link it to its biological basis, but they don't have any medical application yet. Can these models describe mood in a way that is relevant to mood disorders, and help doctors and psychologists predict subsequent clinical evolution? With the objective of extending this framework to real-life fluctuations and to assess its clinical relevance, this study will combine a neuroimaging session with a smartphone-based, longitudinal follow-up. Three groups of 96 subjects each will be recruited: depressive disorder, bipolar disorder and healthy controls. They will have their mood fluctuations assessed first in the lab (in the neuroimaging experiment), then in their daily lives (by providing a few ratings and choices every day on the smartphone app).\n\nThis study will allow to better understand the differences in how patients' mood reacts to daily events, as compared to people who don't suffer from depression or bipolar disorder. The combination of the two steps will allow to assess whether a short neuroimaging evaluation can be useful to predict subsequent clinical evolution during the following months.\n\nThe investigators wanted to add two optional ancillary studies. The first uses a mobile application for implicit, passive, and longitudinal mood assessments through emotion tracking. Indeed, it seems relevant to add this type of evaluation alongside explicit assessments to more accurately detect mood fluctuations.\n\nThe second study uses a mobile application that allows voice recordings. The analysis of these vocal parameters will help to characterize a specific linguistic and vocal profile within the three groups, as well as to identify specific symptoms of conditions such as depression and bipolar disorder.\n\nThese ancillary studies will be offered to both patients and the control group.",[32,62,31,63],"Bipolar Disorder","Mood Disorders",[65,66,67,68,69,70,71,72,73],"cognitive neuroscience","patient-specific modelling","psychiatry","mood disorders","affective disorders","computational modelling","computational psychiatry","prognosis","predictive medicine","2025-06-13",{"date":76,"type":37},"2025-06-24",{"date":78,"type":37},"2024-07-18",{"date":80,"type":22},"2029-07-18",{"name":82,"class":44},"Centre Hospitalier St Anne",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100488554","phase-2-osu6162-as-add-on-in-ssrisnri-resistant-depression-100488554","NCT05641623","OSU6162 as add-on in SSRI\u002FSNRI-resistant Depression","OSU6162 as add-on in SSRI\u002FSNRI-resistant Depression (ODEN): a Double-blind, Placebo-controlled Evaluation of Efficacy and Safety","ODEN","Inclusion Criteria\n\nIn order to be included in the study, subjects must meet the following criteria:\n\n1. Signed informed consent.\n2. Age: 25-65 on the day of screening.\n3. Meeting DSM-5 criteria for major depressive disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI).\n4. A symptom-free period preceding the current episode within the past two years confirmed at interview.\n5. Not significantly improved, as judged by both doctor and patient, after having been treated with one of the following SSRIs\u002FSNRIs: citalopram, escitalopram, paroxetine, sertraline, fluoxetine, duloxetine, or venlafaxine for at least 6 weeks.\n6. Displaying a sum score of MADRS ≥22.\n7. In women of childbearing potential (WOCBP): negative result of a pregnancy test and a method of contraception with a failure rate of less than 1 %. Contraception must be used during the treatment and follow-up period. Acceptable forms of contraception are:\n\n   1. Use of combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\n      * oral\n      * intravaginal\n      * transdermal\n   2. progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n      * oral\n      * injectable\n      * implantable\n   3. Placement of intrauterine device (IUD) or intrauterine hormone releasing system (IUS)\n   4. Bilateral tubal occlusion or ligation\n   5. Vasectomised partner (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate and provided that male partner is the sole sexual partner of the WOCBP trial participant).\n   6. Sexual abstinence.\n8. Male patients must agree to use condoms during the study and for 2 weeks after the end of the study\u002Flast dose of IMP, unless their partner is using a highly efficient method of contraception, as described above.\n\nExclusion criteria\n\nSubjects must not be included in the study if any of the following criteria are met:\n\n1. Meeting MINI criteria at interview for suicidality, manic episode, hypomanic episode, bipolar I, bipolar II, bipolar unspecified, bipolar I with psychotic symptoms, panic disorder (current), agoraphobia, posttraumatic stress disorder, alcohol dependency, alcohol abuse, substance dependency (non-alcoholic), substance abuse (non-alcoholic), psychotic disorders, mood disorders with psychotic features, anorexia nervosa, bulimia nervosa, anorexia nervosa binge eating \u002F purging type, or antisocial personality disorder.\n\n   Meeting MINI criteria at interview for generalised anxiety disorder, obsessive compulsive disorder or social anxiety (social phobia), unless the present symptoms can predominantly be attributed to a diagnosis of major depressive disorder.\n2. A history of substance\u002Falcohol abuse within 2 years prior to screening.\n3. A previous diagnosis of a personality disorder, autism spectrum disorder, attention-deficit\u002Fhyperactivity disorder, or intellectual disability.\n4. Any other previously diagnosed or suspected CNS disorder that according to the investigator renders the patient unsuitable for participation in the trial.\n5. Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc.\n6. Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial.\n7. Any signs or symptoms of somatic illness resulting from assessment of vital signs, physical examination, clinical laboratory tests, and 12-lead ECG that according to the investigator renders the patient unsuitable for participation for safety reasons, including a QTc-time on ECG exceeding 450 ms in men and 460 ms in women.\n8. Any change in dosage of said SSRI\u002FSNRI within 4 weeks prior to screening or at any time during the course of the trial.\n9. Treatment with any other psychoactive drug than said SSRI\u002FSNRI with the exception of using mirtazapine up to 15 mg for sleep, occasional use of benzodiazepines and benzodiazepine-like anxiolytics or hypnotics and occasional use of antihistaminergic sedatives (without anti-dopaminergic effects) within 4 weeks prior to screening and at any time during the course of the trial.\n10. Patients who are receiving concomitant therapy with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazole, itraconazole, telithromycin, clarithromycin, protease inhibitors, quinidine, and terbinafine).\n11. Ongoing treatment with drugs with a narrow therapeutic window where either lower or higher serum levels are potentially harmful (including but not limited to warfarin along with other anticoagulants, digoxin along with other antiarrythmics, anticonvulsants prescribed for treatment of epilepsy, cyclosporine, immunosuppressants, and lithium).\n12. Current treatment with any prescribed or OTC drug that according to the investigator renders the subject unsuitable for participation in the trial.\n13. Previous intake of OSU6162.\n14. Current participation in another clinical trial.\n15. Nursing women.","25 Years",{"count":94,"type":22},180,[25],"This is a randomised, placebo-controlled, parallel-group trial comparing OSU6162 at flexible dosage with placebo as add-on to treatment with an SSRI\u002FSNRI in patients with depression that have not responded to treatment with an SSRI\u002FSNRI per se for at least 6 weeks. The study will last for 6 weeks, after which those not having responded will leave the trial and those having responded will be offered to continue treatment without unblinding for another 4 weeks. Optional Substudy 1 and 2: Baseline and treatment-associated change in reward-related striatal activity per fMRI-assessment. (Substudy 1).\n\nBrain signal variability per fMRI-assessment. (Substudy 1). Probabilistic Reward Task (PRT). (Substudy 2).\n\nWhile assessment of the efficacy and safety of OSU6162 is the main objective of this study, possible differences between the two treatment groups with respect to a number of biomarkers in serum will also be explored.\n\nMulticenter trial: Multiple sites four Gothenburg, Lund, Stockholm and Uppsala.",[32,98,99,100,101,31],"Depressive Disorder, Treatment-Resistant","Depressive Disorder","Depressive Episode","Recurrent Depressive Disorder",[103,104,105,106,107,108,109,110],"Antidepressant","drug therapy, combination","Dopamine Drugs","Dopamine","Selective Serotonin Reuptake Inhibitor","SNRI","SSRI","Serotonin and Norepinephrine Reuptake Inhibitors","2025-03-19",{"date":113,"type":37},"2025-03-24",{"date":115,"type":37},"2022-04-21",{"date":117,"type":22},"2026-08-31",{"name":119,"class":44},"Göteborg University",4]