Menu
Recruiting NCT07185815

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

Phase I / Phase II Interventional Schizophrenia Bipolar I Disorder Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cariprazine Depot, Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day.
Who it may be relevant to
Registry conditions: Schizophrenia, Bipolar I Disorder, Major Depressive Disorder. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Drug Cariprazine Depot
    One single dose of 22 mg
  • Drug Cariprazine Depot
    One single dose of 44 mg
  • Drug Cariprazine Depot MTD
    Three monthly doses of MTD (maximum tolerated dose)
  • Drug Oral Cariprazine 3 mg/day
    Oral Cariprazine 3 mg/day for three months

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 4 centers
  • Mapi Pharma Investigational Site IL-004 — Beersheba
  • Mapi Pharma Investigational Site IL-003 — Ness Ziona
  • Mapi Pharma Investigational Site IL-005 — Ramat Gan
  • Mapi Pharma Investigational Site IL-001 — Tel Aviv
India · 2 centers
  • Mapi Pharma Investigational Site IN-101 — Ahmedabad
  • Mapi Pharma Investigational Site IN-102 — Ahmedabad

Identifiers

NCT: NCT07185815 · Cariprazine Depot I/IIa - 001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗