SchizophreniaPhase 1/2NCT07185815
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
A Phase 1/2 study testing Cariprazine Depot, Cariprazine Depot MTD and Oral Cariprazine 3 mg/day in people with Schizophrenia and Bipolar I Disorder, run by Mapi Pharma Ltd. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- What is being tested?
- Cariprazine Depot, Cariprazine Depot MTD and Oral Cariprazine 3 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Aug 2025to 3 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Israel4 sites, 4 recruiting
- Recruiting
Mapi Pharma Investigational Site IL-004
Beersheba, 8461144
Clinical Research Center
- Recruiting
Mapi Pharma Investigational Site IL-003
Ness Ziona, 741000
Clinical Research Center
- Recruiting
Mapi Pharma Investigational Site IL-005
Ramat Gan, 56621
Clinical Research Center
- Recruiting
Mapi Pharma Investigational Site IL-001
Tel Aviv, 6423906
Clinical Research Center
India2 sites, 2 recruiting
- Recruiting
Mapi Pharma Investigational Site IN-101
Ahmedabad, 380008
Clinical Research Center
- Recruiting
Mapi Pharma Investigational Site IN-102
Ahmedabad, 380016
Clinical Research Center
About this study
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.
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
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- Being tested
- Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day
- Keywords
- Long acting injection, LAI, Subcutaneous, SC, Cariprazine, Cariprazine Depot
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cariprazine DepotDrug
One single dose of 22 mg
Cariprazine DepotDrug
One single dose of 44 mg
Cariprazine Depot MTDDrug
Three monthly doses of MTD (maximum tolerated dose)
Oral Cariprazine 3 mg/dayDrug
Oral Cariprazine 3 mg/day for three months
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: Cariprazine Depot |
| Cohort 2 | Experimental | Not described Receives: Drug: Cariprazine Depot |
| Cohort 3 | Experimental | Not described Receives: Drug: Cariprazine Depot MTD; Drug: Oral Cariprazine 3 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, rate of adverse events (AEs)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Through study completion, up to 24 weeks for each subject in the 3rd cohort
Efficacy - Cohort 3: Clinical Global Impression Scale (CGI)
Measured: Through study completion, up to 24 weeks for each subject in the 3rd cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mapi Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185815
- Sponsor's protocol ID
- Cariprazine Depot I/IIa - 001
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07185815
- Acronym / sponsor ID
- Cariprazine Depot I/IIa - 001
- Conditions
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- Keywords
- Long acting injection, LAI, Subcutaneous, SC, Cariprazine, Cariprazine Depot
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mapi Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cariprazine DepotOne single dose of 22 mg | Drug | Cohort 1 |
| Cariprazine DepotOne single dose of 44 mg | Drug | Cohort 2 |
| Cariprazine Depot MTDThree monthly doses of MTD (maximum tolerated dose) | Drug | Cohort 3 |
| Oral Cariprazine 3 mg/dayOral Cariprazine 3 mg/day for three months | Drug | Cohort 3 |
Primary outcome
Safety, rate of adverse events (AEs)
Time frame: 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)
Time frame: 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
3 secondary outcomes
Tolerability - Incidence and severity of injection site reactions
Time frame: 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)
Time frame: Through study completion, up to 24 weeks for each subject in the 3rd cohort
Efficacy - Cohort 3: Clinical Global Impression Scale (CGI)
Time frame: Through study completion, up to 24 weeks for each subject in the 3rd cohort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cariprazine Depot, Cariprazine Depot MTD and Oral Cariprazine 3 mg/day in people with Schizophrenia and Bipolar I Disorder, run by Mapi Pharma Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Weiser, Prof. (97236973776, CarD@mapi-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, rate of adverse events (AEs) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.