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NCT04959032
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Phase 3 trial testing Lumateperone 42 mg in Schizophrenia in 228 participants. Completed in 7 August 2024.
25 July 2024
Quick facts
| Lead sponsor | Intra-Cellular Therapies, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 228 |
| Start date | 8 July 2021 |
| Primary completion | 25 July 2024 |
| Estimated completion | 7 August 2024 |
| Sites | 43 locations across Serbia, United States, Bulgaria, Poland |
Drugs / interventions tested
- Lumateperone 42 mg — full drug profile →
- Placebo
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Intra-Cellular Therapies, Inc. — full company profile →
Who can join
Adults 18 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Novel Antipsychotic Lumateperone (Iti-007) in the Treatment of Schizophrenia: A Systematic Review.
Longo G, Cicolini A, Orsolini L, Volpe U. · · 2023 · cited 12× · PMID 38137089 · DOI 10.3390/brainsci13121641 -
Unlocking the potential of lumateperone and novel anti-psychotics for schizophrenia.
Ahmad SR, Zeyaullah M, AlShahrani AM, Khan MS, et al · · 2025 · PMID 40161932 · DOI 10.34172/bi.30259
Verify or expand the search:
- PubMed search for NCT04959032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lumateperone 42 mg
Trials testing the same drug.
- NCT04779177 — Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective D · Phase 1 · completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
- NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
- NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
- NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
- NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting
Other Intra-Cellular Therapies, Inc. trials
Trials by the same sponsor.
- NCT06786286 — A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects · Phase 1 · completed
- NCT06627413 — Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizoph · Phase 1 · completed
- NCT06557902 — Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder · Phase 1 · recruiting
- NCT05732194 — Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteer · Phase 1 · completed
- NCT05470101 — A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04959032 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Intra-Cellular Therapies, Inc.
- Last refreshed: 7 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04959032.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing