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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: CarD@mapi-pharma.com
• Phone: 97236973776

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venous Tourniquet with Low-Dose Sugammadex vs Arterial Tourniquet for Seizure Monitoring During ECT

  40 patients undergoing ECT will have a venous tourniquet on one arm and an arterial tourniquet on the other to see which method better reveals motor seizures.

  Recruiting Medipol University · Istanbul · NCT07534475

• À deux, c'est mieux — group program to improve romantic relationships for young adults with severe mental illness

  This program will try a 12-week, small-group course to help single adults with severe mental illness build skills for dating, communication, and closer social relationships.

  Recruiting at 2 sites Centre hospitalier de Ville-Evrard, France · Épinay-sur-Seine, Île-de-France Region and 1 other locations · NCT07316803

• Valbenazine for adults with tardive dyskinesia who remain symptomatic on or after a VMAT2 inhibitor

  This trial will test whether valbenazine reduces involuntary movements in adults with tardive dyskinesia who still have symptoms while taking or after stopping a VMAT2 inhibitor.

  Recruiting at 19 sites Phase 4 Neurocrine Biosciences · Bryant, Arkansas and 18 other locations · NCT07105111

• Enhancing Veteran-Clinician Collaboration in VA Care for Serious Mental Illness

  This study tests a 10-session group program to help Veterans with serious mental illness collaborate better with their clinicians and care teams.

  Recruiting VA Office of Research and Development · San Diego, California and 2 other locations · NCT06898879

• Peer-delivered illness self-management program for college students with serious mental illnesses

  This study tests if a peer-led program called Taking Action can help college students with serious mental illnesses manage their condition better and improve their academic performance.

  Recruiting Temple University · Philadelphia, Pennsylvania · NCT06700902

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.