Actively Recruiting
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
Led by Mapi Pharma Ltd. · Updated on 2026-05-01
24
Participants Needed
6
Research Sites
95 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official Title
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 64 years (inclusive)
- Meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder, or major depressive disorder (for cohorts 1 and 2)
- Clinically stable with no deterioration and on a stable dose of oral antipsychotic or antidepressant medication other than Cariprazine for at least 4 weeks prior to screening
- Eligible for treatment with oral Cariprazine 3 mg/day, with a Clinical Global Impression-Severity (CGI-S) score of 1 to 4
- Body mass index (BMI) between 18.5 and 35
- Able to sign an informed consent form
- Adult subjects with current diagnosis of schizophrenia, naïve to or treated with antipsychotics (for cohort 3)
You will not qualify if you...
- Schizophrenia subjects with Positive and Negative Syndrome Scale (PANSS) item scores greater than 4 on P4 Excitement/Hyperactivity, P6 Suspiciousness/Persecution, P7 Hostility, G8 Uncooperativeness, or G14 Poor Impulse Control
- Subjects with schizoaffective disorder, delirium, dementia, amnestic or other cognitive disorders, or severe personality disorders
- Use of investigational drugs or participation in clinical studies with investigational products within 3 months prior to screening
- History or current cardiovascular or cerebrovascular disease
- History of seizures or conditions lowering seizure threshold
- Use of strong or moderate CYP3A4 inhibitors or inducers
- Subjects with suicidal thoughts or behaviors, history of suicidal ideation in the past year, or suicide attempt in the past 5 years
- History of orthostatic hypotension 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 to 7
- Subjects previously treated with partial D2 agonists aripiprazole and brexipiprazole who suffered clinically relevant akathisia
- For cohort 3 only: subjects treated with oral Clozapine
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Mapi Pharma Investigational Site IN-101
Ahmedabad, India, 380008
Actively Recruiting
2
Mapi Pharma Investigational Site IN-102
Ahmedabad, India, 380016
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3
Mapi Pharma Investigational Site IL-004
Beersheba, Israel, 8461144
Actively Recruiting
4
Mapi Pharma Investigational Site IL-003
Ness Ziona, Israel, 741000
Actively Recruiting
5
Mapi Pharma Investigational Site IL-005
Ramat Gan, Israel, 56621
Actively Recruiting
6
Mapi Pharma Investigational Site IL-001
Tel Aviv, Israel, 6423906
Actively Recruiting
Research Team
M
Mark Weiser, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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