[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474404":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":48,"slug":20,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemp-Derived Cannabidiol Solution","EXPERIMENTAL","Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks",[13],"Drug: Cannabidiol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Cannabidiol","Custom formulation of a hemp-derived, high-CBD product that contains no THC.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rosemary Smith, B.S.","CONTACT","617-855-3338","CBDstudy@mclean.harvard.edu",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-71.17867,42.39593,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Staci Gruber, Ph.D.","Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core","100474404",false,"NCT05457465","Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder","Inclusion Criteria:\n\n* Provides informed consent\n* Between the ages of 18-65\n* Fluent in English\n* Meets DSM-5 criteria for bipolar disorder (type I or II)\n* Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)\n* On a stable pharmacotherapeutic regimen\n\nExclusion Criteria:\n\n* Not fluent in English\n* Estimated IQ \\\u003C75\n* Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)\n* Endorsement of suicidality\n* Experiencing acute manic episode\n* Experiencing acute depressive episode\n* History of head injury\u002Floss of consciousness \\>5 minutes\n* Current regular use of cannabinoid products\n* Pregnant or breastfeeding\n* Presence of serious medical illness or neurological disorder\n* Allergy to palm oil\n* Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis\n* Currently enrolled in another clinical trial that involves a treatment\n* Elevated LFTs at screening visit","ALL","18 Years","65 Years",{"count":57,"type":58},25,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.",[64],"Bipolar Disorder",[17],"2026-03-24",{"date":68,"type":69},"2026-03-30","ACTUAL",{"date":71,"type":69},"2023-06-01",{"date":73,"type":58},"2026-12",{"name":5,"class":6},1]