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NCT04369391
A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
Phase 1 trial testing SEP363856 150 mg in Schizophrenia in 150 participants. Completed in 10 November 2020.
10 November 2020
Quick facts
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 18 June 2020 |
| Primary completion | 10 November 2020 |
| Estimated completion | 10 November 2020 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- SEP363856 150 mg — full drug profile →
- Placebo
- moxifloxacin 400 mg — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A clinical study to investigate the effect of an investigational drug in adults with schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart). This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 7 locations in the US. The study will last approximately 7 weeks.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2 -
New and emerging treatments for schizophrenia: a narrative review of their pharmacology, efficacy and side effect profile relative to established antipsychotics.
Lobo MC, Whitehurst TS, Kaar SJ, Howes OD. · · 2022 · cited 74× · PMID 34838528 · DOI 10.1016/j.neubiorev.2021.11.032 -
Unlocking the Therapeutic Potential of Ulotaront as a Trace Amine-Associated Receptor 1 Agonist for Neuropsychiatric Disorders.
Kuvarzin SR, Sukhanov I, Onokhin K, Zakharov K, et al · · 2023 · cited 17× · PMID 37509616 · DOI 10.3390/biomedicines11071977 -
Trace amine-associated receptor 1 (TAAR1) agonism for psychosis: a living systematic review and meta-analysis of human and non-human data.
Siafis S, Chiocchia V, Macleod MR, Austin C, et al · · 2024 · cited 16× · PMID 39036710 · DOI 10.12688/wellcomeopenres.21302.1 -
A randomized, single-dose, crossover study of the effects of ulotaront on electrocardiogram intervals in subjects with schizophrenia.
Tsukada H, Milanovic SM, Darpo B, Xue H, et al · · 2023 · cited 11× · PMID 36949248 · DOI 10.1111/cts.13512 -
ACNP 61<sup>st</sup> Annual Meeting: Poster Abstracts P271-P540.
· 2022 · cited 7× · PMID 36456694 · DOI 10.1038/s41386-022-01485-0
Verify or expand the search:
- PubMed search for NCT04369391
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials
Trials by the same sponsor.
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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 NCT04369391 (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 Otsuka Pharmaceutical Development & Commercialization, Inc.
- Last refreshed: 26 June 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/NCT04369391.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing