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Tests treatment safety and results for Schizophrenia
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
ClinicalTrials.gov ID: NCT07185815
What this study is testing
What is Cariprazine Depot?
Cariprazine Depot is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- people who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to...
- Clinically stable people (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than...
- Men and women aged 18-64 years (inclusive).
- Body mass index (BMI) 18.5-35.
- Able to sign an informed consent form.
You likely can't join if
- people with schizophrenia with PANSS item scores of \> 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7...
- people 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.
See the full eligibility criteria
- people 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 people (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...
- Men and women aged 18-64 years (inclusive).
- Body mass index (BMI) 18.5-35.
- Able to sign an informed consent form.
- Adult people 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
- people 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.
- people 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.
- people 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.
- people with a history of orthostatic hypotension and/or syncope.
- people clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).
- people with CGI-S score of 5-7.
- people previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.
- For cohort 3 only: people treated with oral Clozapine.
The study team makes the final eligibility decision.
Where it's taking place
- Ahmedabad, India
- Beersheba, Israel
- Ness Ziona, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahmedabad, India; Beersheba, Israel; Ness Ziona, Israel; Ramat Gan, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.