[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650628":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":52,"collaborators":54,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":87,"whyStopped":21,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Northumbria University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Group Assignment","EXPERIMENTAL","All participants will complete a no-lithium condition (control) followed by a lithium condition (intervention). During both conditions, visual and non-visual responses to controlled light exposure are assessed.",[13,14],"Drug: Lithium carbonate (Priadel)","Other: Controlled light exposure",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Lithium carbonate (Priadel)","Oral lithium carbonate 600 mg daily for 7 days prior to the second laboratory assessment (and for both days while in the laboratory)",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Controlled light exposure","Participants undergo 90-minute dim light (\\\u003C1 lux) and light exposure (100-850 lux) conditions during laboratory assessments to evaluate visual and non-visual responses to light.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Nayantara Santhi","CONTACT","0191 227 4055","nayantara.santhi@northumbria.ac.uk",{"name":33,"role":29,"phone":34,"phoneExt":21,"email":35},"Saranea Ganesan","+447587590262","saranea.g@northumbria.ac.uk",[37],{"facility":5,"status":21,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Newcastle upon Tyne","Tyne & Wear","NE1 8SG","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-1.61396,54.97328,{"lat":47,"lon":46},[50,51],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},{"name":33,"role":29,"phone":34,"phoneExt":21,"email":35},{"type":53,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[55,57],{"name":56,"class":6},"Newcastle University",{"name":58,"class":6},"Northumberland, Tyne and Wear NHS Foundation Trust","100650628","examining-lithiums-mechanism-in-bipolar-disorder-100650628",false,"NCT07750925","Examining Lithium's Mechanism in Bipolar Disorder","Investigating the Acute Effect of Lithium on Visual and Non-visual Responses to Light in Healthy Individuals","HELIOS-BD 2","Inclusion Criteria:\n\n* Aged between 18 and 40 years old\n* Fluent in English (both spoken and written)\n* Sleep duration between 6.5 and 9 hours daily\n* Have a regular normal sleep schedule with bedtime (weekdays) between 21:30 and 01:00.\n* BMI between 18 and 28kg\u002Fm2\n* Currently enrolled and registered with a general practitioner\n* Female participants only: should use effective contraception or refrain from engaging in sexual activity that could result in pregnancy during participation in the study.\n\nExclusion Criteria:\n\n* History of psychiatric or neurological disorders\n* First-degree family history of psychosis or severe mood disorder\n* Current or past suicidal ideation or self-harm\n* Current, chronic infections or diseases.\n* Life-threatening allergies, specifically a nut allergy.\n* Known visual disorders e.g., colour blindness, glaucoma, cataracts, diabetic retinopathy.\n* Known medical conditions that could affect the conduct of the study including\n\n  * sleep disorders\n  * cancer\n  * diabetes\n  * anaemia\n  * epilepsy\n  * psoriasis\n  * thyroid disorders\n  * kidney disease\n  * severe eczema\n  * anemia\n  * migraines\n* Taking any long-term or regular medications other than oral contraceptives (e.g., antidepressants, diuretics (water-tablets), pain killers or anti-inflammatory drugs (such as ibuprofen) or medications for high blood pressure).\n* Have donated blood in the past 1 month\n* Regular or recent recreational drug use\n* Chronic alcohol addiction\u002Fmisuse\n* Known contraindication to magnetic resonance imaging such as pacemaker or metal implants, recent surgery, severe claustrophobia and\u002For recent head or neck tattoos.\n* A current smoker (including use of cigarettes, vapes, and\u002For cigars).\n* Planning to travel across time zones at any point in time during the conduct of the study or have travelled across time zones within 1 month prior to enrolment.\n* Currently work night shifts\n* Been a shift worker in the past 3 months.\n* Current enrolment in any other interventional studies\n* Enrolment in any other interventional studies in the 1 month prior to the start of participation in this study",true,"ALL","18 Years","40 Years",{"count":72,"type":73},45,"ESTIMATED","INTERVENTIONAL",[76],"NA","The primary objective of the current study is to examine the acute effect of lithium on the visual and non-visual responses to light in a sample of healthy participants. Our experiments will investigate the effects of lithium on light sensitivity at the level of the retina as well as central visual and non-visual pathways.\n\nOur primary hypothesis is that the administration of lithium to healthy volunteers will reduce the magnitude of a range of non-visual responses to light including melatonin suppression, alertness, performance, mood and electrophysiology in a manner that is dependent of the amount of lithium in the brain. To better understand the postulated effects of lithium on light sensitivity and to examine its relationship at the level of the retina, we will assess the visual and non-visual responses to light, as well as the distribution of lithium in the brain using a non-invasive imaging technique. In addition to that, we also aim to examine the impact of both lithium and light on a molecular level through whole blood transcriptome sequencing.",[79,80],"Healthy","Bipolar",[82,83,84,85,86],"Circadian Rhythms","Performance","Mood","Lithium","Light sensitivity","NOT_YET_RECRUITING","2026-08-03",{"date":90,"type":91},"2026-08-06","ACTUAL",{"date":93,"type":73},"2026-08-01",{"date":95,"type":73},"2029-04-30",{"name":5,"class":6},1]