Идёт набор NCT07185815

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

Фаза I / Фаза II С лечением Schizophrenia Bipolar I Disorder Major Depressive Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cariprazine Depot, Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day.
Кому может быть актуально: Состояния в реестре: Schizophrenia, Bipolar I Disorder, Major Depressive Disorder. Базовые параметры: 18 лет — 64 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Индия, Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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.

Обзор

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.

Вмешательства

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

Первичные конечные точки

Safety, rate of adverse events (AEs) [Срок оценки: 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) [Срок оценки: 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]

Вторичные конечные точки (3)

Tolerability - Incidence and severity of injection site reactions [Срок оценки: 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) [Срок оценки: Through study completion, up to 24 weeks for each subject in the 3rd cohort]
Efficacy - Cohort 3: Clinical Global Impression Scale (CGI) [Срок оценки: Through study completion, up to 24 weeks for each subject in the 3rd cohort]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет