Study of Monthly Subcutaneous Cariprazine Depot Injection for Treatment of Schizophrenia, Bipolar I Disorder, and Major Depressive Disorder in Adults Aged 18 to 64

What this Trial Is About

Researchers are evaluating the pharmacokinetics, safety, tolerability, and efficacy of a once-a-month, long-acting subcutaneous injection of Cariprazine Depot in adults eligible for oral Cariprazine treatment. This study involves subjects diagnosed with schizophrenia, bipolar I disorder, or major depressive disorder, focusing on those who are clinically stable or antipsychotic-naive, depending on the cohort. The research is conducted as an open-label, multi-center Phase IIIa trial sponsored by Mapi Pharma Ltd. Participants will receive escalating doses of Cariprazine Depot across three cohorts. Cohorts 1 and 2 receive single doses of 22 mg or 44 mg, respectively, while cohort 3 receives three monthly doses of the maximum tolerated dose MTD. Additionally, oral Cariprazine at 3 mgday is administered for three months for comparison. The study is non-randomized and open-label, with no masking, to assess dose effects and treatment responses. During the study, participants will be monitored for adverse events, injection site reactions, and plasma levels of Cariprazine and its metabolites over 22 to 24 weeks. The efficacy in cohort 3 will be evaluated using symptom scores such as the Positive and Negative Symptom Score PANSS and Clinical Global Impression Scale CGI. Safety and tolerability assessments are conducted throughout, with the study duration extending up to 24 weeks per participant.

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