Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
NCT ID: NCT07185815
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2025-08-01
2027-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Cariprazine Depot
One single dose of 22 mg
Cohort 2
Cariprazine Depot
One single dose of 44 mg
Cohort 3
Cariprazine Depot MTD
Three monthly doses of MTD (maximum tolerated dose)
Oral Cariprazine 3 mg/day
Oral Cariprazine 3 mg/day for three months
Interventions
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Cariprazine Depot
One single dose of 22 mg
Cariprazine Depot
One single dose of 44 mg
Cariprazine Depot MTD
Three monthly doses of MTD (maximum tolerated dose)
Oral Cariprazine 3 mg/day
Oral Cariprazine 3 mg/day for three months
Eligibility Criteria
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Inclusion Criteria
* 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/s or antidepressant/s other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg/day, with CGI-S score of 0-4.
* Men and women aged 18-64 years (inclusive).
* Body mass index (BMI) 18.5-35.
* Able to sign an informed consent form.
* 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).
Exclusion Criteria
* Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.
* Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening.
* History or current cardiovascular or cerebrovascular disease.
* History of seizures or conditions that lower the seizure threshold.
* Use of concomitant administration of strong or moderate CYP3A4 inhibitors.
* Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.
* 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.
* Subjects with a history of orthostatic hypotension and/or syncope.
* Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).
* Subjects with CGI-S score of 5-7.
* Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.
* For cohort 3 only: Subjects treated with oral Clozapine.
18 Years
64 Years
ALL
No
Sponsors
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Mapi Pharma Ltd.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center
Ness Ziona, , Israel
Israeli Medical Center for Alzheimer
Ramat Gan, , Israel
Tel Aviv, Israel
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Clinical Research Center
Role: primary
Clinical Research Center
Role: primary
Clinical Research Center
Role: primary
Other Identifiers
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Cariprazine Depot I/IIa - 001
Identifier Type: -
Identifier Source: org_study_id
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