[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658818":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":32,"interventions":49,"overallOfficials":60,"centralContacts":64,"locations":20,"responsibleParty":70,"collaborators":20,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":20,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":20,"enrollmentInfo":81,"targetDuration":20,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":20,"overallStatus":90,"whyStopped":20,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":20},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline to End of Week 6 in Hamilton Anxiety Rating (HAM-A) Scale 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 anxiety.","Baseline, Week 6",[14,17],{"measure":15,"description":16,"timeFrame":12},"Change from Baseline to the End of Week 6 in Clinical Global Impression-Severity (CGI-S) Anxiety 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 participant at this time? CGI-S 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 participants. Here, higher score indicates higher symptom severity.",{"measure":18,"description":11,"timeFrame":19},"Change from Baseline to the End of Week 1 in HAM-A Total Score","Baseline, Week 1",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"QUADRUPLE",[28,29,30,31],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[33,39,43],{"label":34,"type":35,"description":36,"interventionNames":37},"JNJ-99245354: Dose 1","EXPERIMENTAL","Participants will receive JNJ-99245354 dose 1 as an adjunctive therapy once daily for up to 6 weeks in the double blind (DB) period. Eligible participants can enter the open-label (OL) period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks.",[38],"Drug: JNJ-99245354",{"label":40,"type":35,"description":41,"interventionNames":42},"JNJ-99245354: Dose 2","Participants will receive JNJ-99245354 dose 2 as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks.",[38],{"label":44,"type":45,"description":46,"interventionNames":47},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks.",[38,48],"Drug: Placebo",[50,57],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","JNJ-99245354","JNJ-99245354 will be administered sublingually.",[34,40,44],[56],"ITI-1284",{"type":51,"name":44,"description":58,"armGroupLabels":59,"otherNames":20},"Placebo will be administered sublingually.",[44],[61],{"name":62,"affiliation":5,"role":63},"Intra-Cellular Therapies, Inc. Clinical Trial","STUDY_DIRECTOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":20,"email":69},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",{"type":71,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100658818","phase-3-a-study-of-jnj-99245354-iti-1284-as-an-adjunctive-treatment-in-participants-with-generalized-anxiety-disorder-gad-who-have-an-inadequate-response-to-gad-treatment-100658818",false,"NCT07856420","A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment","A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)","Inclusion criteria:\n\n* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline\n* Medically stable on the basis of clinical laboratory tests performed at screening\n* History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial\n* Body mass index (BMI) within the range 19-40 kilogram per meter squared (kg\u002Fm\\^2) (inclusive)\n\nExclusion criteria:\n\n* Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) text revision (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 (except simple phobias and social anxiety disorder); b. moderate or severe alcohol or substance use disorders (excluding nicotine); d. moderate or severe major depressive disorder; e. any other psychiatric condition (except for mild major depressive disorder \\[MDD\\]) that has been the main focus of treatment\n* Montgomery-asberg depression rating scale (MADRS) total score greater than (\\>)18 at screening or baseline\n* Lifetime history of inadequate response to \\>3 of the approved treatments for GAD at an adequate dose and for an adequate duration\n* The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline","ALL","18 Years",{"count":82,"type":83},705,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).",[89],"Generalized Anxiety Disorder","NOT_YET_RECRUITING","2026-09-28",{"date":93,"type":94},"2026-10-02","ACTUAL",{"date":96,"type":83},"2026-09-30",{"date":98,"type":83},"2030-09-28",{"name":5,"class":6}]