[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471776":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":57,"collaborators":60,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":24,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":24,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Negative ion therapy","ACTIVE_COMPARATOR","High density negative ions at 3.4 trillion ions per second with no detectable ozone, used for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am.",[13],"Device: Negative ion therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Light therapy","4000 Kelvin white fluorescent light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter, used for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am.",[18],"Device: Light therapy",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Negative ion generator",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Fluorescent light box",[15],[29],{"name":30,"affiliation":5,"role":31},"Raymond W Lam, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Vanessa Evans, BSc","CONTACT","604-822-8102","vanessa.evans@ubc.ca",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Djavad Mowafaghian Centre for Brain Health","RECRUITING","Vancouver","British Columbia","V6T 2A1","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-123.11934,49.24966,{"lat":51,"lon":50},[54,56],{"name":55,"role":35,"phone":36,"phoneExt":24,"email":37},"Vanessa Evans",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"type":31,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Raymond Lam","Principal Investigator",[61,63,65,68,70,72],{"name":62,"class":6},"University of Toronto",{"name":64,"class":6},"Université de Montréal",{"name":66,"class":67},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":69,"class":6},"McMaster University",{"name":71,"class":6},"Ontario Brain Institute",{"name":73,"class":6},"Centre for Addiction and Mental Health","100471776","light-and-ion-maintenance-in-treatment-for-depression-limit-d-feasibility-study-100471776",false,"NCT05423275","Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study","Inclusion Criteria:\n\n* Diagnostic and Statistical Manual (DSM-5) criteria for MDD, as determined by the Structured Clinical Interview for DSM-5 (SCID).\n* Taking a first-line antidepressant at approved doses (Table 1), with dose unchanged in the past month.\n* Participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;\n* In remission as defined by score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) at both the screening visit and baseline visit, at least 2 weeks apart.\n* Willing and able to complete self-report and online assessments including sufficient fluency in English or French.\n\nExclusion Criteria:\n\n* Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime). Note that comorbid anxiety disorders (e.g., generalized anxiety disorder, social anxiety disorder) will not be excluded if the anxiety disorder is not the primary diagnosis.\n* Diagnosis of MDD with seasonal pattern (i.e., seasonal affective disorder, SAD) or with psychotic features (lifetime).\n* Significant personality disorder diagnosis \\[e.g., antisocial\\] by MINI and clinical assessment.\n* High suicidal risk, defined by clinician judgment.\n* History of alcohol or substance use disorder, with a severity of at least moderate or severe, within 6 months before screening.\n* Significant neurological disorders, head trauma, or other unstable medical conditions.\n* Regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers); Note - Stimulant medications for Attention-Deficit Hyperactivity Disorder are allowed if dose is stable in past month.\n* History of severe antidepressant discontinuation effects.\n* Retinal disease or other eye condition (e.g., macular degeneration) precluding the use of bright light treatment.\n* Use of photosensitizing medication (thioridazine, chloroquine, 8-methoxypsoralen) within 1 week of baseline visit.\n* Initiated formal psychotherapy (e.g., cognitive-behavioural therapy) within 3 months of Visit 1, or who plan to initiate psychotherapy during the study.\n* Continued use of any other evidence-based treatment for depression.","ALL","19 Years","65 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","Antidepressants are widely used as first-line treatments for major depressive disorder (MDD). Clinical guidelines recommend 6-24 months of \"maintenance\" antidepressant treatment, after patients achieve symptom remission, to prevent relapse but many people stop antidepressants too soon relapse into another depressive episode. We will test non-medication treatments, negative ion therapy and light therapy, to see they can substitute for antidepressants to prevent relapse. This is a \"feasibility\" study to see if participants use study treatments properly, before doing a larger, definitive trial. In this 28-week study, 100 participants with MDD who are in remission with antidepressants will be treated with light therapy or negative ion therapy (with half of devices active and half inactive) while slowly discontinuing the antidepressant, and monitored for relapse.",[91],"Major Depressive Disorder, Recurrent, in Remission",[93,94,95,96,97,98],"antidepressants","discontinuation","relapse prevention","light therapy","negative ions","depression","2024-12-04",{"date":101,"type":102},"2024-12-09","ACTUAL",{"date":104,"type":102},"2023-03-13",{"date":106,"type":85},"2027-06",{"name":5,"class":6},1]