[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-unipolar\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-unipolar":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,63,101,129,156,180,213,236,261],{"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":4,"briefSummary":22,"conditions":23,"keywords":45,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100551600","natural-history-of-depression-bipolar-disorder-and-suicide-risk-100551600",false,"NCT06462196","Natural History of Depression, Bipolar Disorder and Suicide Risk","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","ALL","18 Years","120 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Behavioral Symptoms","Suicide","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Ketamine","Depression, Unipolar","Depressive Symptoms","Treatment Resistant Depression","Major Depressive Disorder","Depression, Bipolar",[46,25,43,47,48,49,42],"Neurobiology","Bipolar Disorder","Biomarkers","Suicide Risk","RECRUITING","2026-06-26",{"date":53,"type":54},"2026-06-29","ACTUAL",{"date":56,"type":54},"2024-09-09",{"date":58,"type":20},"2030-06-01",{"name":60,"class":61},"National Institute of Mental Health (NIMH)","NIH",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100596874","efficacy-of-a-personalized-response-based-transdiagnostic-intervention-for-emotional-disorders-delivered-via-the-internet-a-protocol-for-an-adaptive-randomized-controlled-trial-100596874","NCT07051148","Efficacy of a Personalized, Response-based Transdiagnostic Intervention for Emotional Disorders Delivered Via the Internet: A Protocol for an Adaptive Randomized Controlled Trial","Inclusion Criteria:\n\n* Spanish speakers\n* OASIS score +\u002F= 8\n* ODSIS score +\u002F= 7\n* Access to Internet\n* Email\n\nExclusion Criteria:\n\n* Severe mental disorder: schizophrenia\u002Fbipolar disorder\n* Active substance abuse\n* High suicide risk\n* Ongoing psychological\u002Fpharmacological treatment\n* Interfering physical illness","70 Years",{"count":71,"type":20},366,"INTERVENTIONAL",[74],"NA","This adaptive randomized controlled trial evaluates the efficacy of a transdiagnostic, internet-delivered psychological intervention for emotional disorders, tailored to patient´s early clinical response. 366 adults with clinically significant symptoms of depression and\u002For anxiety will begin a 12 module self-applied program. Based on sympton reduction after the first three modules, participants will be classified as early or late responders and randomized into different experimental arms. The main hypothesis is that a hybrid format (self-applied modules plus synchronous sessions with a therapist) will yield better outcomes for late responders. Outcomes include symptom reduction, emotional regulation and internet based therapheutic alliance.",[77,78,40],"Emotional Disorders","Anxiety",[80,81,82,83,77,84,85,86,87,88,89],"transdiagnostic","internet based therapy","anxiety","depression","adaptive intervention","blended treatment","digital interventions","personalization","personalized treatment","adaptive trial","NOT_YET_RECRUITING","2026-05-21",{"date":93,"type":54},"2026-05-27",{"date":95,"type":20},"2027-05-01",{"date":97,"type":20},"2030-07",{"name":99,"class":100},"Universitat Jaume I","OTHER",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":72,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":62},"100590925","adjunctive-bright-light-therapy-in-adolescents-with-depression-and-eveningness-100590925","NCT06973759","Adjunctive Bright Light Therapy in Adolescents With Depression and Eveningness","Bright Light Therapy for Adolescents With Depression and Eveningness - a Randomized, Placebo-controlled, Assessor-blinded Study","Inclusion Criteria:\n\n1. Chinese, aged 12-19 years old;\n2. Written informed assent\u002Fconsent of participation into the study is given by the participant and his\u002Fher parent or guardian (for those aged under 18), respectively;\n3. Having a DSM-5 diagnosis of unipolar non-seasonal depression as confirmed by the Chinese version of the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS) psychiatric interview, DSM-5 Seasonal specifier, AND having a score on Children's Depression Rating Scale (CDRS-R) at least 40;\n4. Being classified as evening chronotype according to the score on the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ), i.e. \\\u003C12.\n\nExclusion Criteria:\n\n1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, organic mental disorders, or intellectual disabilities;\n2. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by K-SADS;\n3. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;\n4. Initiation of or change in antidepressant medication within past 4 weeks;\n5. Having been or is currently receiving any structured psychotherapy;\n6. With hearing or speech deficit;\n7. Night shift worker;\n8. Trans-meridian flight across at least two time zones in the past 3 months and during the study;\n9. Presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.","12 Years","19 Years",{"count":111,"type":20},90,[74],"This study examines the efficacy of bright light therapy as a treatment for adolescents diagnosed with unipolar non-seasonal depression who exhibit an evening chronotype.",[40],[116,117,118,119],"Depression","Eveningness","Bright light therapy","Adolescents","2026-03-18",{"date":122,"type":54},"2026-03-19",{"date":124,"type":54},"2025-11-01",{"date":126,"type":20},"2028-06-30",{"name":128,"class":100},"Chinese University of Hong Kong",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":72,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100488436","fmri-neurofeedback-in-depression-100488436","NCT05640089","FMRI-neurofeedback in Depression","A Randomised Controlled Trial of FMRI-neurofeedback in Depression","Inclusion Criteria:\n\n* Diagnosis of a depressive disorder (ICD-10: F32 or F33)\n* Has been on stable antidepressant medication (single or combination treatment) for at least 4 weeks\n* Current depression (QIDS \\>= 17)\n* If required to meet recruitment targets the minimum entry score will be reduced QIDS \\>= 13 (i.e. still corresponding to a moderate level of depression)\n\nExclusion Criteria:\n\n* Exclusion criteria for MRI (e.g. cardiac pacemaker, certain metallic implants)\n* History of psychotic disorder bipolar disorder, or psychotic depression\n* Current use of illegal drugs (any in the last four weeks)\n* Current excessive alcohol consumption that interferes with daily functioning\n* History of neurological disease that could influence the fMRI signal and\u002For the anatomical alignment (e.g. territorial stroke, multiple sclerosis, brain tumour)",{"count":137,"type":20},120,[74],"Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction. The goal of this clinical trial is to compare fMRI-neurofeedback plus standard care with standard care in patients with depression.\n\nParticipants will either receive standard care, or standard care plus a fMRI neurofeedback training, consisting of 5 neurofeedback training sessions. Symptom severity will be assessed before, immediately after and 6 months after the intervention.",[40],[116,142,24,143,144,145],"Depressive Disorder","Mood Disorders","Mental Disorders","fMRI Neurofeedback","2025-03-20",{"date":148,"type":54},"2025-03-24",{"date":150,"type":54},"2023-01-25",{"date":152,"type":20},"2027-04-30",{"name":154,"class":100},"Maastricht University Medical Center",3,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":69,"enrollmentInfo":162,"targetDuration":4,"studyType":72,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":62},"100546279","intermittent-theta-burst-stimulation-for-major-depression-an-intensity-response-study-100546279","NCT06392867","Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study","Inclusion Criteria:\n\n* are aged between 18 and 70;\n* have a MDD diagnosis, single or recurrent episode, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria and confirmed by means of the Mini-International Neuropsychiatric Interview (MINI);\n* have a score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HDRS17) in their current episode;\n* have failed to have a clinically significant response to two or more standard antidepressant treatments during their current episode;\n* have received stable psychopharmacological treatment within 4 weeks prior to screening; and\n* have normal thyroid function, Complete Blood Count, electrolytes, and liver enzyme levels based on pre-study blood work.\n\nExclusion Criteria:\n\n* have a history of substance abuse or dependence in the past 3 months;\n* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;\n* show active suicidal intent (MADRS item 10 score \\>4);\n* are pregnant;\n* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;\n* have a metal implant or any other common MRI and TMS exclusion criteria;\n* take antiepileptic drugs or benzodiazepines corresponding to a dose of \\>1 mg lorazepam per day;\n* have had initiation or dose change of any psychotropic medication in the 4 weeks prior to screening or\n* have undergone TMS in the past.",{"count":163,"type":20},246,[74],"The United States Food and Drug Administration (FDA) approved intermittent theta-burst stimulation (iTBS) in 2018 as a form of repetitive transcranial magnetic stimulation (rTMS). Hospitals worldwide use it to treat major depressive disorder (MDD). It is safe, effective, even for depressed patients unable to respond to standard pharmacological treatment and is more efficient than standard rTMS. In accordance with the approved treatment protocol, patients experience considerable sensory discomfort at a stimulation intensity of 120% of their resting motor threshold (rMT). Antidepressant effects of iTBS are believed to be mediated by modulating prefrontal excitability. There is still a lack of evidence to support the choice of 120% rMT as the optimal stimulation intensity, and the presumed superiority of higher stimulation intensities over lower intensities has yet to be proven. This knowledge gap has clinical implications since more tolerated treatments may lead to greater adherence, resulting in improved outcomes.\n\nThe current study proposes a randomized, triple-arm, controlled trial to compare the efficacy of iTBS at 75% (iTBS75) and 120% (iTBS120) rMT with sham iTBS (SiTBS). Based on the following considerations, SiTBS was selected to be compared with iTBS75 and iTBS120: SiTBS will reveal placebo antidepressant effects and serve as a control. iTBS75 is selected because iTBS at 80% aMT exhibits significant excitatory effects on the motor cortex and corresponds to approximately 70% rMT. There is however, a distance of about 12.7mm between the coil and the motor cortex, whereas 14.4mm separates the coil from the dorsolateral prefrontal cortex (DLPFC). Accordingly, a resting motor threshold of 70% at the motor cortex corresponds to a distance-adjusted rMT of 75% at the DLPFC. Lastly, iTBS120 is chosen as the standard stimulation intensity in current iTBS depression trials.\n\nIt is our intention to investigate the potential antidepressant effects of iTBS treatment at a much lower stimulation intensity than the one currently employed by most centers in the United States and approved in these centers. Thus, our study can contribute to establishing a treatment regimen with increased adherence and lower withdrawal rates.",[40],[168,43,169,170],"Transcranial magnetic stimulation, TMS","iTBS","TMS treatment for depression","2025-03-11",{"date":173,"type":54},"2025-03-14",{"date":175,"type":54},"2024-01-08",{"date":177,"type":20},"2026-10-26",{"name":179,"class":100},"The Hong Kong Polytechnic University",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":72,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100512937","bioclock-bright-light-therapy-for-depressive-disorders-100512937","NCT05958940","BioClock: Bright Light Therapy for Depressive Disorders","BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 65.\n* Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)\n* A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)\n* Sufficient knowledge of Dutch or English language to fill in questionnaires\n* Provided Informed consent\n\nExclusion Criteria:\n\n* A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)\n* Current psychotic episode (as assessed with the M.I.N.I.)\n* Prominent active suicidality (score 10 or higher on the M.I.N.I. module)\n* Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry\n* participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,\n* Use of melatonin or agomelatine in the last month\n* Current use of antibiotics\n* Current use of light sensitivity increasing medication\n* Travelled across more than 1 time zone during past month or during the treatment\n* Travelled to sunny holiday locations\u002Fwinter sports during past month\n* pre-existing eye and skin disorders (retinitis pigmentosa, porphyria, chronic actinic dermatitis and sun-induced urticaria)\n* Systemic disorders with potential retinal involvement (rheumatoid arthritis and systemic lupus erythematosus)\n* Suffering from colour blindness (assessed by Ishihara colour plates)\n* Participated in night shift work in the last three months\n* (Retinal) blindness, severe cataract and glaucoma\n* Light-induced migraine or epilepsy\n* Pregnancy, or parents with a child younger than 18 months old","65 Years",{"count":189,"type":20},231,[74],"Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.\n\nThis clinical trial has three main goals:\n\n* Optimize the administration of BLT for patients with depressive episodes.\n* Gain a deeper understanding of the treatment mechanisms.\n* Determine which patients benefit the most from the treatment.\n\nThe specific objectives are as follows:\n\n* Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT.\n* Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes.\n* Identify patient characteristics and behaviours that can predict treatment outcomes.\n* Develop a brain model to better understand the impact of BLT on the brain.\n\nIn this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups:\n\n* Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands.\n* LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day.\n* LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light.\n\nThe study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.",[40,44],[116,194,195,196,197,198,199,200,201,202],"Bright Light Therapy","Chronotherapy","Circadian Rhythm","Sleep","Life Style","Ecological Momentary Assessment","Actigraphy","Dim light melatonin onset","Response predictors","2025-01-07",{"date":205,"type":54},"2025-01-09",{"date":207,"type":54},"2024-02-08",{"date":209,"type":20},"2026-12",{"name":211,"class":100},"Universiteit Leiden",2,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":15,"minAge":220,"maxAge":187,"enrollmentInfo":221,"targetDuration":4,"studyType":72,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":62},"100557174","the-cerebral-and-cognitive-changes-after-intermittent-theta-burst-stimulation-itbs-treatment-for-depression-100557174","NCT06534684","The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression","The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial","Inclusion criteria:\n\n* Patients must meet the diagnostic criteria of at least a moderate depression\n* The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years\n* Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS\n* Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI\n\nExclusion criteria:\n\n* The current depressive episode is in the mild range\n* The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and\u002For electroconvulsive therapy,\n* The current depressive episode is clearly triggered by grief or a recent major stressful life event\n* Bipolar disorder\n* Borderline personality disorder\n* Psychotic symptoms\n* Alcohol or substance abuse\u002Faddiction in the last 6 months\n* Current eating disorders\n* Obsessive- compulsive disorders\n* Post-traumatic stress disorder\n* A life-time medical history of seizure\n* Neurological or neurosurgical pathologies\n* Cardiac or systemic disease\n* Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.)\n* Autism\n* Pregnancy\n* Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability","22 Years",{"count":222,"type":20},50,[74],"The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.",[40,226],"Depression Moderate","2024-08-01",{"date":229,"type":54},"2024-08-02",{"date":231,"type":54},"2024-02-12",{"date":233,"type":20},"2029-02-12",{"name":235,"class":100},"University Hospital of North Norway",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":72,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":62},"100523191","effects-of-cbt-and-blt-in-youth-with-unipolar-depression-and-evening-chronotype-100523191","NCT06092411","Effects of CBT and BLT in Youth With Unipolar Depression and Evening Chronotype","Effects of Cognitive Behavioural Therapy and Bright Light Therapy in Youth With Unipolar Depression and Evening Chronotype: An Assessor-blind Parallel-group Randomised Controlled Trial","DELAY","Inclusion Criteria:\n\n1. Chinese aged 12-20 years old.\n2. Written informed consent of participation into the study is given by the participant and his\u002Fher parent or guardian (for those aged under 18).\n3. Being able to comply with the study protocol.\n4. Having a DSM-5 diagnosis of depressive disorders.\n5. Having a score of ≥ 40 on Children's Depression Rating Scale (CDRS-R).\n6. Having a score of ≤ 41 on Horne-Östberg Morning-Eveningness Questionnaire (MEQ; classified as evening chronotype).\n7. Having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, and 12:00pm or later for 15-20 years at least 3 nights per week in the past 3 months.\n\nExclusion Criteria:\n\n1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities.\n2. Initiation of and change of medication that may interfere with circadian rhythm within past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).\n3. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt).\n4. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study.\n5. Initiation of or change in antidepressant medication within past 3 months.\n6. Having been or is currently receiving any structured psychotherapy.\n7. With hearing or speech deficit.\n8. Night shift worker.\n9. Trans-meridian flight in the past 1 month and during intervention.\n10. Presence of an eye disease (e.g., retinal blindness, severe cataract, glaucoma).","20 Years",{"count":246,"type":20},162,[74],"The goal of this prospective randomised controlled trial is to examine the effects of cognitive behavioural therapy and bright light therapy in youths with unipolar depression and evening chronotype. The main questions it aims to answer are:\n\n1. What is the efficacy of CBT-D and CBT-D plus bright light therapy in reducing depression severity in adolescents with depression and eveningness?\n2. What are the effects of CBT-D and CBT-D plus bright light therapy on the subjective and objective sleep and circadian measures, as well as the quality of life, daytime symptoms, and functioning (e.g., sleepiness, fatigue)?\n\nParticipants will participate in 8 weekly group sessions of CBT-D intervention based on the well-established CBT elements for treating depression. Concurrently participants will also be asked to wear a portable light device at home for 30 minutes daily for seven weeks, starting from the second week of the group intervention. Participants in the CBT-D only group will receive a placebo light via the device, whereas participants in the CBT-D plus light therapy group will receive the active bright light via the device.",[40,117],[116,117,119,194,251],"Cognitive Behavioural Therapy","2024-04-17",{"date":254,"type":54},"2024-04-22",{"date":256,"type":54},"2023-10-31",{"date":258,"type":20},"2026-10-20",{"name":260,"class":100},"The University of Hong Kong",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":15,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":72,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":62},"100440174","integrated-tele-behavioral-activation-and-fall-prevention-for-low-income-homebound-seniors-with-depression-100440174","NCT05011864","Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression","Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Older Adults With Depression","TBF","Inclusion Criteria:\n\n* Age 50+\n* English or Spanish proficiency\n* 24-item Hamilton Rating Scale for Depression score \\> 15\n* 12-item Fall Risk Questionnaire score \\>4\n\nExclusion Criteria:\n\n* Recently (\\\u003C 4 weeks) initiated or modified antidepressant pharmacotherapy\n* High suicide risk\n* Probable dementia\n* Bipolar disorder\n* Substance use\u002Fmisuse\n* Current participation in any psychotherapy or FP program\n* Bedbound status","50 Years","100 Years",{"count":272,"type":20},320,[74],"This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor\u002Fcoach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.",[40,276],"Fall","2024-01-07",{"date":279,"type":54},"2024-01-09",{"date":281,"type":54},"2021-11-01",{"date":283,"type":20},"2026-12-31",{"name":285,"class":100},"University of Texas at Austin"]