[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05457465":3,"trial-entities:NCT05457465":94,"trial-summary:NCT05457465":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":70,"locations":73,"central_contacts":89,"overall_officials":91,"references":92,"see_also_links":93},"NCT05457465","2022P000825","Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder","RECRUITING","2026-12","2026-03","2026-03-30","2023-06-01","Mclean Hospital","OTHER",false,"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.","This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suffer from anxiety.\n\nThis investigation consists of a four-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, potentially eligible participants will come to the hospital for a screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, a urine screen, and a blood draw. Eligible participants will return for a baseline visit consisting of additional clinical and quality of life questionnaires, a brief cognitive assessment, and a buccal swab for genetic analysis. Participants will be given study product to use for the duration of the study, and will be instructed to self-administer the solution under the tongue twice daily for four weeks. Throughout the treatment period, participants will complete short in-person or remote visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments.",[18],"Bipolar Disorder",[20],"Cannabidiol","INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},25,"ESTIMATED",[29],{"type":30,"name":20,"description":31,"armGroupLabels":32},"DRUG","Custom formulation of a hemp-derived, high-CBD product that contains no THC.",[33],"Hemp-Derived Cannabidiol Solution",[35],{"measure":36,"description":37,"timeFrame":38},"Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)","Anxiety will be assessed using a number of self-report and administered clinical ratings scales: the primary outcome measure will be the Beck Anxiety Inventory (BAI), which is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 (not at all) to 3 (severely). The total score ranges from 0 (no anxiety) to 63 (severe anxiety).","4 weeks",[40],{"measure":41,"description":42,"timeFrame":38},"Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)","Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), which is a 21-item self-report measure used to rate symptoms of depression on a scale of 0 (none) to 3 (very much). The total score ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).","ALL","18 Years","65 Years",{"inclusion":47,"exclusion":54,"raw_text":69},[48,49,50,51,52,53],"Provides informed consent","Between the ages of 18-65","Fluent in English","Meets DSM-5 criteria for bipolar disorder (type I or II)","Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)","On a stable pharmacotherapeutic regimen",[55,56,57,58,59,60,61,62,63,64,65,66,67,68],"Not fluent in English","Estimated IQ \\\u003C75","Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)","Endorsement of suicidality","Experiencing acute manic episode","Experiencing acute depressive episode","History of head injury\u002Floss of consciousness \\>5 minutes","Current regular use of cannabinoid products","Pregnant or breastfeeding","Presence of serious medical illness or neurological disorder","Allergy to palm oil","Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis","Currently enrolled in another clinical trial that involves a treatment","Elevated LFTs at screening visit","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",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"McLean Hospital","Belmont","Massachusetts","02478","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Rosemary Smith, B.S.","CONTACT","617-855-3338","CBDstudy@mclean.harvard.edu",{"lat":87,"lon":88},42.39593,-71.17867,[90],{"name":82,"role":83,"phone":84,"email":85},[],[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[18],[],{"nct_id":4,"found":98,"summary":99,"prompt_version":109},true,{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an open-label study, meaning both you and the researchers will know you are receiving Cannabidiol. It plans to enroll 25 participants.","completed","Cannabidiol for Anxiety and Depression in Bipolar Disorder","This study is looking at whether a custom-made, high-CBD product called Cannabidiol, which contains no THC, can help people with bipolar disorder (type I or II) who also experience anxiety. Researchers want to see if taking Cannabidiol for four weeks can reduce anxiety levels. You might be able to join if you are 18-65 years old, speak English, have bipolar disorder, experience at least moderate anxiety, and are already on stable medication for your condition. The main goal is to measure changes in your self-reported anxiety after four weeks of taking Cannabidiol. This is a small, early-stage study with 25 participants, and its current status is unclear.","The primary outcome is measured at 4 weeks, which is the duration of the intervention.",107,"You will have a phone pre-screening, followed by a screening visit at the hospital for interviews, questionnaires, a urine test, and a blood draw. If eligible, you'll return for a baseline visit with more questionnaires, a cognitive test, and a cheek swab, then take Cannabidiol for four weeks.","Not stated in the trial record.",[20],"v2"]