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

Recruiting now · Phase 1/Phase 2

Conditions studied: Schizophrenia, Bipolar I Disorder, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT07185815

Run by

Mapi Pharma Ltd.

People needed

24

Starts

2025-08-01

Expected to finish

2027-06-03

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Mapi Pharma Investigational Site IN-101 — Ahmedabad, India (enrolling)
• Mapi Pharma Investigational Site IN-102 — Ahmedabad, India (enrolling)
• Mapi Pharma Investigational Site IL-004 — Beersheba, Israel (enrolling)
• Mapi Pharma Investigational Site IL-003 — Ness Ziona, Israel (enrolling)
• Mapi Pharma Investigational Site IL-005 — Ramat Gan, Israel (enrolling)
• Mapi Pharma Investigational Site IL-001 — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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