Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia

Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment

Timeline

Start

2018-04-27

Primary completion

2020-09-30

Completion

2020-12-03

Publications

• Kane JM, Tohami O, Franzenburg KR, Suett M, Sharon N, Merenlender-Wagner A, Eshet R, Harary E, Correll CU. Effects of Long-Term Treatment with TV-46000 on Symptom Improvement Over Time in Stabilized Patients with Schizophrenia. CNS Drugs. 2026 Feb;40(2):247-267. doi: 10.1007/s40263-025-01240-1. Epub 2025 Nov 21.
• Correll CU, Knebel H, Harary E, Eshet R, Tohami O, Suett M, Sharon N, Franzenburg KR, Kane JM. Safety Outcomes with the Long-Acting Subcutaneous Antipsychotic TV-46000 in Schizophrenia: A Post Hoc Analysis of Behavioral, Neuromotor, Endocrine, and Cardiometabolic Outcomes from Two Phase 3 Studies. CNS Drugs. 2025 Nov;39(11):1139-1156. doi: 10.1007/s40263-025-01197-1. Epub 2025 Jul 29.
• Kane JM, Harary E, Eshet R, Tohami O, Weiser M, Leucht S, Merenlender-Wagner A, Sharon N, Davis GL 3rd, Suett M, Franzenburg KR, Correll CU. Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria. Lancet Psychiatry. 2023 Dec;10(12):934-943. doi: 10.1016/S2215-0366(23)00288-2. Epub 2023 Nov 2.

Drugs

Indications