Clinical Trial

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

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-09-15; most recent amendment 2026-04-27.
Trial Details
NCT Number NCT07185815
Lead Sponsor Mapi Pharma Ltd.
Conditions Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
Enrollment 24 participants
Start Date 2025-08-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-01