[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647203":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":58,"centralContacts":63,"locations":70,"responsibleParty":85,"collaborators":68,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":68,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":68,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":68,"overallStatus":106,"whyStopped":68,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Vigonvita Life Sciences","INDUSTRY",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"VV119 capsules","EXPERIMENTAL","Capsule, 2 mg\u002F4 mg \u002F6 mg, administered orally once daily for 6 consecutive weeks",[13,14,15],"Drug: VV119 2mg","Drug: VV119 4mg","Drug: VV119 6mg",{"label":17,"type":18,"description":19,"interventionNames":20},"Active Comparator","ACTIVE_COMPARATOR","Tablet, 20 mg , administered orally once daily for 6 consecutive weeks",[21],"Drug: Aripiprazole tablet",{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","PLACEBO_COMPARATOR","Capsule\u002FTablet, administered orally once daily for 6 consecutive weeks",[27],"Drug: Placebo",[29,36,42,48,53],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","VV119 2mg","VV119 capsules 1 capsule (2mg\u002Fcapsule) + VV119 capsules placebo 2 capsules + aripiprazole tablet placebo 2 tablets",[9],[35],"Low-dose group",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"VV119 4mg","VV119 capsules 2 capsules (2mg\u002Fcapsule) + VV119 capsules placebo 1 capsules + aripiprazole tablet placebo 2 tablets",[9],[41],"Medium-dose group",{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"VV119 6mg","VV119 capsule 3 capsules (2mg\u002Fcapsule) + aripiprazole tablet placebo 2 tablets",[9],[47],"High-dose group",{"type":30,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Aripiprazole tablet","VV119 capsule placebo 3 capsules (2mg\u002Fcapsule) + aripiprazole tablet 2 tablets",[17],[17],{"type":30,"name":23,"description":54,"armGroupLabels":55,"otherNames":56},"VV119 capsule placebo 3 capsules (2mg\u002Fcapsule) + aripiprazole tablet placebo 2 tablets",[23],[57],"Placebo Comparator",[59],{"name":60,"affiliation":61,"role":62},"Wang Gang","Beijing Anding Hospital of Capital Medical University","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":68,"email":69},"Duan Huaqing","CONTACT","+86-18061926005",null,"huaqing.duan@vigonvita.cn",[71],{"facility":61,"status":68,"city":72,"state":73,"zip":68,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Beijing","Beijing Municipality","China","CN",{"type":77,"coordinates":78},"Point",[79,80],116.39723,39.9075,{"lat":80,"lon":79},[83],{"name":84,"role":66,"phone":68,"phoneExt":68,"email":68},"Dong Fang",{"type":86,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR","100647203","phase-2-evaluating-safety-and-efficacy-of-vv119-in-acute-schizophrenia-adults-100647203",false,"NCT07703956","Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults","A Phase 2,Multicenter, Randomized, Double-blind, Placebo and Active Comparator Parallel-controlled Study to Evaluate the Safety and Efficacy of VV119 in Adults With Acute Schizophrenia","Inclusion Criteria:\n\n1. Male or female participants, 18-65 years,inclusive, at screening.\n2. Body Mass Index of 18.5 to 35.0kg\u002Fm2 , and body weight no less than 50.0kg (males), body weight no less than 45.0kg (females).\n3. Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI).\n4. Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening:a.Participans who have been recently hospitalized or who would benefit from hospitalization for an acute exacerbation or relapse of schizophrenia;b.If hospitalized at screening, the participant's current admission for acute exacerbation shall be ≤2 weeks.\n5. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening,Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening:\n\n   Item 1 (P1; delusions) Item 2 (P2; conceptual disorganization) Item 3 (P3; hallucinatory behavior) Item 6 (P6; suspiciousness\u002Fpersecution).\n6. WOCBP and male participants and their partners shall use medically approved effective contraception throughout treatment and for 3 months after the final study drug dose, such as intrauterine devices, contraceptive pills, or condoms.\n7. Participants who are able to understand and follow study plans and instructions; Participants who have voluntarily decided to participate in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Any primary DSM-5 disorder other than schizophrenia.\n2. Investigator-assessed treatment-resistant schizophrenia: participants who failed adequate sequential monotherapy with ≥2 structurally distinct, potent antipsychotics for positive symptoms,Each drug was given at ≥600 mg\u002Fday chlorpromazine equivalents for ≥6 consecutive weeks with poor efficacy.\n3. Subjects with a \\>20% reduction in total PANSS score from screening to baseline. Reduction rate = (Screening total PANSS score - Baseline total PANSS score) \u002F (Screening total PANSS score - 30).\n4. Per investigator assessment via the Columbia-Suicide Severity Rating Scale (C-SSRS), participants with suicidal risk\u002Fintent in the 6 months before screening (answered \"Yes\" to C-SSRS Ideation Item 4 or 5) or any actual suicidal behavior within 12 months prior are excluded. Non-suicidal self-injury in the past year is not exclusionary, though participants with substantial current self-harm risk per clinical judgment will still be excluded.\n5. Electroconvulsive therapy (ECT) within 3 months before screening.\n6. Chronic clozapine use prior to screening.\n7. Discontinuation of short\u002Fintermediate-acting antipsychotics or other psychoactive agents (antidepressants, mood stabilizers, antiepileptics, etc.) for less than 5 half-lives or less than 1 week at randomization.\n8. Long-acting injectable antipsychotics (risperidone paliperidone palmitate, aripiprazole long-acting injectable, etc.) discontinued for less than 5 half-lives at randomization.\n9. Discontinuation of QT-prolonging and torsades de pointes (TdP)-inducing medications (levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, haloperidol, etc.) for less than 5 half-lives at randomization.\n10. Discontinuation of moderate\u002Fpotent CYP3A or CYP2D6 inhibitors\u002Finducers for less than 5 half-lives at randomization, or planned use of such agents throughout the study.\n11. Prior inadequate response to aripiprazole (≥20 mg\u002Fday for minimum 6 weeks).\n12. History or active epilepsy (febrile convulsions excluded).\n13. History or current presence of neuroleptic malignant syndrome (NMS).\n14. History or active malignancy of any type.\n15. History or active ocular disease: open\u002Fclosed-angle glaucoma, or acute bacterial\u002Fviral eye infection within 1 week pre-screening.\n16. History or active tardive dyskinesia.\n17. History of conditions\u002Fsurgeries altering drug ADME or conferring safety risks (gastrectomy, gastrointestinal anastomosis, bowel resection, urinary obstruction, dysuria, etc.).\n18. History of drug\u002Ffood allergies, or hypersensitivity to study drug, its components, or aripiprazole analogs.\n19. Pregnant or lactating female at screening\u002Fbaseline.\n20. History of alcohol\u002Fpsychoactive substance abuse\u002Fdependence (excluding caffeine, nicotine) within 1 year pre-screening, or positive urine drug\u002Falcohol screen at screening.\n21. Clinically significant abnormal vital signs\u002Fphysical exam findings at screening\u002Fbaseline per investigator judgment that may interfere with study participation.\n22. Orthostatic drop ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes of standing at screening.\n23. QTcF \\>450 ms (male) \u002F \\>470 ms (female) at screening\u002Fbaseline (Fridericia formula); or other clinically significant 12-lead ECG abnormalities interfering with study participation per investigator.\n24. Severe unstable medical illness (cardiac, hepatic, renal, hematologic, endocrine, neurologic, etc.) deemed ineligible by investigator.\n25. Elevated ALT\u002FAST \\>1.5×ULN, Cr \\>1.2×ULN, TBIL \\>1.5×ULN, or other clinically significant lab abnormalities at screening\u002Fbaseline per investigator assessment.\n26. Positive HBsAg, HCV-Ab, HIV-Ab or TP-Ab at screening.\n27. Participation in another interventional trial with investigational product\u002Fdevice within 3 months pre-screening, or ongoing trial enrollment.\n28. Other exclusion criteria per investigator discretion .","ALL","18 Years","65 Years",{"count":98,"type":99},500,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This will be a multicenter, randomized, double-blind, placebo and active comparator parallel-controlled study designed to assess the safety and efficacy of VV119 (2.0 to 6.0 mg) for the treatment of adult participants diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase.",[105],"Schizophrenia","NOT_YET_RECRUITING","2026-07-12",{"date":109,"type":110},"2026-07-15","ACTUAL",{"date":112,"type":99},"2026-07-31",{"date":114,"type":99},"2027-12-31",{"name":5,"class":6},1]