Status:
RECRUITING
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
Lead Sponsor:
Mapi Pharma Ltd.
Conditions:
Major Depressive Disorder (MDD)
Bipolar 1 Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
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 eli...
Eligibility Criteria
Inclusion
- Key
- 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).
- 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).
- Key
Exclusion
- Subjects with schizophrenia with PANSS item scores of \> 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 3 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07185815
Start Date
August 1 2025
End Date
June 3 2027
Last Update
December 3 2025
Active Locations (3)
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1
Clinical Research Center
Ness Ziona, Israel, 741000
2
Israeli Medical Center for Alzheimer
Ramat Gan, Israel, 56621
3
Tel Aviv, Israel
Tel Aviv, Israel, 6423906