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NCT06229210
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Phase 3 trial testing Lumateperone in Schizophrenia in 500 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Intra-Cellular Therapies, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 25 January 2024 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 50 locations across United States, Serbia |
Drugs / interventions tested
- Lumateperone (LUMATEPERONE) — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Bipolar Disorder — all drugs for Bipolar Disorder →
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
Intra-Cellular Therapies, Inc. — full company profile →
Who can join
Adults 5 to 17, any sex, with Schizophrenia or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of Common Adverse Events
Time frame: Up to 6 months
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Sponsor's own description
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06229210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lumateperone
Trials testing the same drug.
- NCT05890768 — Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine · Phase 4 · withdrawn
- NCT05061719 — An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder · Phase 3 · completed
- NCT05061706 — Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder · Phase 3 · completed
- NCT04985942 — Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder · Phase 3 · completed
- NCT04285515 — Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder · Phase 3 · 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 NCT06229210 (US National Library of Medicine, public domain)
- 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 July 2025
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/NCT06229210.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing