[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607227":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":39,"locations":45,"responsibleParty":116,"collaborators":11,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":11,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":11,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":140,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Mapi Pharma Ltd.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL",null,[13],"Drug: Cariprazine Depot",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Cohort 3",[20,21],"Drug: Cariprazine Depot MTD","Drug: Oral Cariprazine 3 mg\u002Fday",[23,28,31,35],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","Cariprazine Depot","One single dose of 22 mg",[9],{"type":24,"name":25,"description":29,"armGroupLabels":30,"otherNames":11},"One single dose of 44 mg",[15],{"type":24,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Cariprazine Depot MTD","Three monthly doses of MTD (maximum tolerated dose)",[18],{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Oral Cariprazine 3 mg\u002Fday","Oral Cariprazine 3 mg\u002Fday for three months",[18],[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Mark Weiser, Prof.","CONTACT","97236973776","CarD@mapi-pharma.com",[46,62,70,83,94,105],{"facility":47,"status":48,"city":49,"state":11,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Mapi Pharma Investigational Site IN-101","RECRUITING","Ahmedabad","380008","India","IN",{"type":54,"coordinates":55},"Point",[56,57],72.58727,23.02579,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":11,"phoneExt":11,"email":11},"Clinical Research Center",{"facility":63,"status":48,"city":49,"state":11,"zip":64,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Mapi Pharma Investigational Site IN-102","380016",{"type":54,"coordinates":66},[56,57],{"lat":57,"lon":56},[69],{"name":61,"role":42,"phone":11,"phoneExt":11,"email":11},{"facility":71,"status":48,"city":72,"state":11,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Mapi Pharma Investigational Site IL-004","Beersheba","8461144","Israel","IL",{"type":54,"coordinates":77},[78,79],34.7913,31.25181,{"lat":79,"lon":78},[82],{"name":61,"role":42,"phone":11,"phoneExt":11,"email":11},{"facility":84,"status":48,"city":85,"state":11,"zip":86,"country":74,"countryCode":75,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Mapi Pharma Investigational Site IL-003","Ness Ziona","741000",{"type":54,"coordinates":88},[89,90],34.79868,31.92933,{"lat":90,"lon":89},[93],{"name":61,"role":42,"phone":11,"phoneExt":11,"email":11},{"facility":95,"status":48,"city":96,"state":11,"zip":97,"country":74,"countryCode":75,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Mapi Pharma Investigational Site IL-005","Ramat Gan","56621",{"type":54,"coordinates":99},[100,101],34.81065,32.08227,{"lat":101,"lon":100},[104],{"name":61,"role":42,"phone":11,"phoneExt":11,"email":11},{"facility":106,"status":48,"city":107,"state":11,"zip":108,"country":74,"countryCode":75,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Mapi Pharma Investigational Site IL-001","Tel Aviv","6423906",{"type":54,"coordinates":110},[111,112],34.78057,32.08088,{"lat":112,"lon":111},[115],{"name":61,"role":42,"phone":11,"phoneExt":11,"email":11},{"type":117,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607227","phase-1-pharmacokinetics-safety-tolerability-and-efficacy-of-a-subcutaneous-long-acting-injection-of-cariprazine-cariprazine-depot-in-subjects-eligible-for-treatment-with-oral-cariprazine-100607227",false,"NCT07185815","Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine","A Prospective, Dose Escalating, Open Label, Multi-center, Phase I\u002FIIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.","Key Inclusion Criteria:\n\n* Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).\n* Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic\u002Fs or antidepressant\u002Fs other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg\u002Fday, with CGI-S score of 1-4.\n* Men and women aged 18-64 years (inclusive).\n* Body mass index (BMI) 18.5-35.\n* Able to sign an informed consent form.\n* Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only).\n\nKey Exclusion Criteria:\n\n* Subjects with schizophrenia with PANSS item scores of \\> 4 on any of the following: P4 Excitement\u002FHyperactivity; P6 Suspiciousness\u002Fpersecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.\n* Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.\n* Use of an investigational drug, and\u002For participation in clinical studies with an investigational product within 3 months prior to screening.\n* History or current cardiovascular or cerebrovascular disease.\n* History of seizures or conditions that lower the seizure threshold.\n* Use of concomitant administration of strong or moderate CYP3A4 inhibitors.\n* Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.\n* Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years.\n* Subjects with a history of orthostatic hypotension and\u002For syncope.\n* Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).\n* Subjects with CGI-S score of 5-7.\n* Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.\n* For cohort 3 only: Subjects treated with oral Clozapine.","ALL","18 Years","64 Years",{"count":129,"type":130},24,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE1","PHASE2","The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.",[137,138,139],"Schizophrenia","Bipolar I Disorder","Major Depressive Disorder",[141,142,143,144,145,25],"Long acting injection","LAI","Subcutaneous","SC","Cariprazine","2026-04-27",{"date":148,"type":149},"2026-05-01","ACTUAL",{"date":151,"type":149},"2025-08-01",{"date":153,"type":130},"2027-06-03",{"name":5,"class":6},6]