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Aviv","6423906",{"type":53,"coordinates":108},[109,110],34.78057,32.08088,{"lat":110,"lon":109},[113],{"name":60,"role":42,"phone":11,"phoneExt":11,"email":11},{"type":115,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":126,"type":127},24,"ESTIMATED","INTERVENTIONAL",[130,131],"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.",[134,135,136],"Schizophrenia","Bipolar I Disorder","Major Depressive Disorder",[138,139,140,141,142,25],"Long acting injection","LAI","Subcutaneous","SC","Cariprazine","2026-04-27",{"date":145,"type":146},"2026-05-01","ACTUAL",{"date":148,"type":146},"2025-08-01",{"date":150,"type":127},"2027-06-03",{"name":5,"class":6},6]