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 Phase 2 Interventional Study
Schizophrenia Bipolar I Disorder Major Depressive Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Mapi Pharma Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Key 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 antips…
Contacts

Mark Weiser, Prof.

97236973776

CarD@mapi-pharma.com

CONTACT