[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654931":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":28,"interventions":35,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":85,"collaborators":21,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":21,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":21,"enrollmentInfo":96,"targetDuration":21,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":21,"overallStatus":53,"whyStopped":21,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Adverse Events (AEs)","An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.","Up to Week 52",[14,18],{"measure":15,"description":16,"timeFrame":17},"Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score","The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM A total score ranges from 0 to 56 where higher score indicates greater severity in symptoms.","Baseline up to Week 52",{"measure":19,"description":20,"timeFrame":17},"Change from Baseline in Clinical Global Impression-Severity (CGI S) Score","The CGI-S scale is a standardized assessment tool that the clinician can use to rate the overall severity of illness. The CGI-S asks the clinician: \"Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. Higher scores indicate worse outcome.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"NA","SINGLE_GROUP","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE",[29],{"label":30,"type":31,"description":32,"interventionNames":33},"ITI-1284","EXPERIMENTAL","Participants from acute ITI-1284 GAD studies (Study ITI-1284-301 \\[NCT06480383\\] and Study ITI-1284-302 \\[NCT06701903\\]) (\"roll-over participants\") who meet all eligibility criteria will directly enter this study at the completion of Week 6 of the double-blind treatment period of the lead-in studies (Study ITI-1284-301 and Study ITI-1284-302). Roll-over participants will continue with their assigned monotherapy treatment of ITI-1284 or GAD-approved treatment along with ITI-1284 from the lead-in studies during this open label study. De novo participants who meet all eligibility criteria will either receive ITI-1284 monotherapy or ITI-1284 along with GAD approved treatment for up to 52 weeks.",[34],"Drug: ITI-1284",[36],{"type":37,"name":30,"description":38,"armGroupLabels":39,"otherNames":21},"DRUG","ITI-1284 will be administered sublingually.",[30],[41],{"name":42,"affiliation":5,"role":43},"Intra-Cellular Therapies, Inc. Clinical Trial","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":21,"email":49},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[51,65,75],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":21},"CalNeuro Research","RECRUITING","Los Angeles","California","90025","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-118.24368,34.05223,{"lat":63,"lon":62},{"facility":66,"status":53,"city":67,"state":68,"zip":69,"country":57,"countryCode":58,"cosmosGeoPoint":70,"geoPoint":74,"contacts":21},"Sunshine Medical Research Studies Inc","Miami","Florida","33186",{"type":60,"coordinates":71},[72,73],-80.19366,25.77427,{"lat":73,"lon":72},{"facility":76,"status":53,"city":77,"state":78,"zip":79,"country":57,"countryCode":58,"cosmosGeoPoint":80,"geoPoint":84,"contacts":21},"SPRI Clinical Trials, LLC","Brooklyn","New York","11235",{"type":60,"coordinates":81},[82,83],-73.94958,40.6501,{"lat":83,"lon":82},{"type":86,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100654931","phase-3-a-study-to-asses-safety-and-tolerability-of-iti-1284-given-alone-or-as-an-additional-treatment-in-participants-with-generalized-anxiety-disorder-gad-100654931",false,"NCT07807865","A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)","An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment","Inclusion criteria for Roll-over participants:\n\n* Provide written informed consent before the initiation of any study specific procedures\n* Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study\n* Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males\n* Ability to follow study instructions and likely to complete all required visits\n* In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)\n* If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study\n\nInclusion criteria for De-novo participants:\n\n* Provide written informed consent before the initiation of any study-specific procedures\n* Male or female participants greater than or equal to (\\>=) 18 years of age\n* Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg\u002Fm\\^2), inclusive\n* At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (GAD) (current GAD) as confirmed by the investigator or sponsor-approved rater using the structured clinical interview for DSM-5, clinical trials version (SCID 5-CT)\n* Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study\n\nExclusion criteria for Roll-over participants\n\n* In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her\u002Fhis participation in the study or is considered to be an imminent danger to her\u002Fhimself or others, and\u002For: a. At baseline, the participant scores \"yes\" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) \"Since Last Visit\" version; b. At baseline, the participant scores \\>= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator\n* The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline\n* Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study\n* The participant has any other condition that may be detrimental to the participant if they participate in the study\n* In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study\n\nExclusion criteria for De-novo participants\n\n* Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder\n* Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)\n* MADRS total score greater than (\\>) 18 at screening or baseline\n* The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time\n* The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients","ALL","18 Years",{"count":97,"type":98},900,"ESTIMATED","INTERVENTIONAL",[101],"PHASE3","The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.",[104],"Generalized Anxiety Disorder","2026-09-24",{"date":107,"type":108},"2026-09-29","ACTUAL",{"date":110,"type":108},"2026-09-03",{"date":112,"type":98},"2030-03-04",{"name":5,"class":6},3]