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

NCT07185815 | Recruiting Phase 1

• 1 other identifier: Cariprazine Depot I/IIa - 001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 6

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 eligible for treatment with oral Cariprazine.

Conditions

Bipolar I Disorder; Major Depressive Disorder; Schizophrenia

Keywords

Long acting injection; LAI; Subcutaneous; SC; Cariprazine; Cariprazine Depot

Outcome Measures

Primary Outcomes (2)

• Safety, rate of adverse events (AEs)

  Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort

• Plasma concentration of cariprazine and its active metabolites (DCAR, DDCAR)

  Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort

Secondary Outcomes (3)

• Tolerability - Incidence and severity of injection site reactions

  Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort

• Efficacy - Cohort 3: Positive and Negative Symptom Score (PANSS)

  Through study completion, up to 24 weeks for each subject in the 3rd cohort

• Efficacy - Cohort 3: Clinical Global Impression Scale (CGI)

  Through study completion, up to 24 weeks for each subject in the 3rd cohort

Study Arms (3)

Cohort 1

EXPERIMENTAL

Drug: Cariprazine Depot

Cohort 2

EXPERIMENTAL

Drug: Cariprazine Depot

Cohort 3

EXPERIMENTAL

Drug: Cariprazine Depot MTD; Drug: Oral Cariprazine 3 mg/day

Interventions

Cariprazine Depot DRUG

One single dose of 22 mg

Cohort 1

Cariprazine Depot MTD DRUG

Three monthly doses of MTD (maximum tolerated dose)

Cohort 3

Oral Cariprazine 3 mg/day DRUG

Oral Cariprazine 3 mg/day for three months

Cohort 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 1-4.
• Men and women aged 18-64 years (inclusive).
• Body mass index (BMI) 18.5-35.
• Able to sign an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mapi Pharma Ltd.: lead

Study Sites (6)

Mapi Pharma Investigational Site IN-101

Ahmedabad, 380008, India

RECRUITING

Mapi Pharma Investigational Site IN-102

Ahmedabad, 380016, India

RECRUITING

Mapi Pharma Investigational Site IL-004

Beersheba, 8461144, Israel

RECRUITING

Mapi Pharma Investigational Site IL-003

Ness Ziona, 741000, Israel

RECRUITING

Mapi Pharma Investigational Site IL-005

Ramat Gan, 56621, Israel

RECRUITING

Mapi Pharma Investigational Site IL-001

Tel Aviv, 6423906, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Central Study Contacts

Mark Weiser, Prof.

CONTACT

97236973776; CarD@mapi-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 3, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4); IN (2)