Monthly subcutaneous long-acting cariprazine injection for adults with schizophrenia, bipolar I disorder, or major depressive disorder.

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.

This will test a once-a-month subcutaneous long-acting form of cariprazine for adults with schizophrenia, bipolar I disorder, or major depressive disorder who are eligible for the oral medication.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Mapi Pharma Ltd. (Industry-sponsored)
• Locations: 6 sites (Ahmedabad and 5 other locations)
• Trial ID: NCT07185815 on ClinicalTrials.gov

What this trial studies

This phase 1/2 trial uses dose-escalating monthly subcutaneous injections of a long-acting cariprazine formulation to measure pharmacokinetics, safety, and tolerability across cohorts and to test efficacy in a dedicated efficacy cohort. Early cohorts focus on PK and safety/tolerability, while cohort 3 enrolls adults with schizophrenia to examine clinical effect. Eligible participants are adults 18–64 years with BMI 18.5–35 who are appropriate candidates for oral cariprazine 3 mg/day; some cohorts require clinical stability on other psychotropic medications and the schizophrenia cohort may include antipsychotic-naïve or previously treated patients. The sponsor is Mapi Pharma and study sites are located in India (Ahmedabad) and Israel (Beersheba).

Who should consider this trial

Good fit: Adults aged 18–64 with schizophrenia, bipolar I disorder, or major depressive disorder who are eligible for oral cariprazine 3 mg/day, have BMI 18.5–35, and meet the trial's stability or schizophrenia-specific cohort criteria are the intended candidates.

Not a fit: Patients with unstable or severe illness (for example high PANSS item scores), major medical comorbidities, who fall outside the age or BMI ranges, or who are not eligible for cariprazine 3 mg/day are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, a monthly injectable cariprazine could reduce the need for daily pills and improve adherence and symptom stability for people who respond to cariprazine.

How similar studies have performed: Long-acting injectable formulations of other antipsychotics have improved adherence and reduced relapse in prior work, but a subcutaneous long-acting depot of cariprazine is novel and currently has limited clinical data.

Eligibility criteria

Key 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 1-4.
* 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 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).
* 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.

Where this trial is running

Ahmedabad and 5 other locations

• Mapi Pharma Investigational Site IN-101 — Ahmedabad, India (Recruiting)
• Mapi Pharma Investigational Site IN-102 — Ahmedabad, India (Recruiting)
• Mapi Pharma Investigational Site IL-004 — Beersheba, Israel (Recruiting)
• Mapi Pharma Investigational Site IL-003 — Ness Ziona, Israel (Recruiting)
• Mapi Pharma Investigational Site IL-005 — Ramat Gan, Israel (Recruiting)
• Mapi Pharma Investigational Site IL-001 — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Mark Weiser, Prof.

Conditions Schizophrenia; Bipolar I Disorder; Major Depressive Disorder; Long acting injection; LAI; Subcutaneous; SC; Cariprazine