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Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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/IIa 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.

NCT07185815•Mapi Pharma Ltd.

View on ClinicalTrials.gov

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 eligible for treatment with oral Cariprazine.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).

Exclusion Criteria

•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).
+3 more criteria

Locations (3)

Clinical Research Center

Ness Ziona, Israel

Israeli Medical Center for Alzheimer

Ramat Gan, Israel

Tel Aviv, Israel

Key Dates

Start Date

August 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

June 3, 2027

Last Updated

December 3, 2025

Enrollment

ESTIMATED participants

Conditions

Major Depressive Disorder (MDD)Bipolar 1 DisorderSchizophrenia

Interventions

Cariprazine Depot

DRUG

Cariprazine Depot

DRUG

Cariprazine Depot MTD

DRUG

Oral Cariprazine 3 mg/day

DRUG

Contacts

Mark Weiser, Prof.

CONTACT

97236973776 CarD@mapi-pharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

Inclusion Criteria

Exclusion Criteria

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