Taking people in IsraelPhase 1/2
Tests a monthly injection of cariprazine in adults with schizophrenia, bipolar I, or depression
Tests a once-monthly cariprazine injection in adults with schizophrenia, bipolar I, or depression.
Key facts
- Who runs it
- Mapi Pharma Ltd.
- Where
- Beersheba, Ness Ziona, Ramat Gan, and Tel Aviv, IsraelSee the 4 sitesAlso in 1 other country, 2 sites
- Trial code
- Registry title
- Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 24 people, planned
- Started
- 1 Aug 2025
- Expected to end
- 3 Jun 2027
- Type of study
- Interventional, 3 groups
- Treatments tested
- Cariprazine Depot
- Cariprazine Depot MTD
- Oral Cariprazine 3 mg/day
- Record updated
- 1 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-64 with schizophrenia, bipolar I disorder or major depressive disorder who are clinically stable. It tests a monthly long-acting cariprazine injection under the skin.
- Age
- 18 to 64 years (inclusive)
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia, bipolar I disorder or major depressive disorder (cohorts 1 and 2); schizophrenia only (cohort 3). Clinically stable, with a CGI-S score of 1-4.
- Earlier treatment
- Stable dose of an oral antipsychotic or antidepressant other than cariprazine for at least 4 weeks before screening. People who are clinically stable on oral cariprazine cannot join cohorts 1-2. Cohort 3 can include people not yet treated with antipsychotics.
- Biomarker or test result
- Body mass index (BMI) of 18.5-35. No gene or marker test is asked for.
Main reasons for not taking part
- Schizoaffective disorder, delirium, dementia or other cognitive disorders, or severe personality disorders
- Past or current heart or brain blood vessel disease
- History of seizures or conditions that lower the seizure threshold
- Recent suicidal thoughts or behaviors (past year), or a suicide attempt in the past 5 years
- Use of strong or moderate CYP3A4 inhibitors or inducers
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening
- Use of concomitant administration of strong or moderate CYP3A4 inhibitors
- Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated
- 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
- Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders
- History or current cardiovascular or cerebrovascular disease
- History of seizures or conditions that lower the seizure threshold
- 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 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 clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only)
- Subjects with CGI-S score of 5-7
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Israel
Also in 1 other country, 2 sites
- Mapi Pharma Investigational Site IL-004Beersheba, IsraelContact: Clinical Research CenterTaking people
- Mapi Pharma Investigational Site IL-003Ness Ziona, IsraelContact: Clinical Research CenterTaking people
- Mapi Pharma Investigational Site IL-005Ramat Gan, IsraelContact: Clinical Research CenterTaking people
- Mapi Pharma Investigational Site IL-001Tel Aviv, IsraelContact: Clinical Research CenterTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Cohort 1Treatment being tested
Treatment: Cariprazine Depot
- Cohort 2Treatment being tested
Treatment: Cariprazine Depot
- Cohort 3Treatment being tested
Treatment: Cariprazine Depot MTD and Oral Cariprazine 3 mg/day
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Plain-language title
- Tests a monthly injection of cariprazine in adults with schizophrenia, bipolar I, or depressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07185815, who can take part
- Record updated
- 1 May 2026