NCT04072354

A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Completed Phase 3 Last updated 26 June 2024

What this trial tests

Phase 3 trial testing SEP-363856 50mg in Schizophrenia in 463 participants. Completed in 12 September 2023.

Timeline

11 September 2019

Primary endpoint
12 May 2023

12 September 2023

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	463
Start date	11 September 2019
Primary completion	12 May 2023
Estimated completion	12 September 2023
Sites	58 locations across Colombia, Russia, Ukraine, Serbia, Bulgaria, United States

Drugs / interventions tested

• SEP-363856 50mg — full drug profile →
• SEP-363856 75mg — full drug profile →
• Placebo

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 13 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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
2. The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.
   Correll CU, Solmi M, Cortese S, Fava M, et al · · 2023 · cited 90× · PMID 36640403 · DOI 10.1002/wps.21056
3. Therapeutic Potential of TAAR1 Agonists in Schizophrenia: Evidence from Preclinical Models and Clinical Studies.
   Dedic N, Dworak H, Zeni C, Rutigliano G, et al · · 2021 · cited 78× · PMID 34947997 · DOI 10.3390/ijms222413185
4. 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
5. Ulotaront: review of preliminary evidence for the efficacy and safety of a TAAR1 agonist in schizophrenia.
   Achtyes ED, Hopkins SC, Dedic N, Dworak H, et al · · 2023 · cited 38× · PMID 37165101 · DOI 10.1007/s00406-023-01580-3
6. New Developments in the Treatment of Schizophrenia: An Expert Roundtable.
   Kantrowitz JT, Correll CU, Jain R, Cutler AJ. · · 2023 · cited 23× · PMID 36932673 · DOI 10.1093/ijnp/pyad011
7. Novel Compounds in the Treatment of Schizophrenia-A Selective Review.
   Tsapakis EM, Diakaki K, Miliaras A, Fountoulakis KN. · · 2023 · cited 21× · PMID 37626549 · DOI 10.3390/brainsci13081193
8. Progress and Pitfalls in Developing Agents to Treat Neurocognitive Deficits Associated with Schizophrenia.
   Veselinović T, Neuner I. · · 2022 · cited 18× · PMID 35831706 · DOI 10.1007/s40263-022-00935-z