A Phase 3 interventional study of NBI-1117568 and Placebo in Schizophrenia, sponsored by Neurocrine Biosciences. Recruiting at 21 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 284 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
Drug: NBI-1117568
Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
Drug: Placebo
NBI-1117568 will be administered per schedule specified in the arm description.
Placebo will be administered per schedule specified in the arm description.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Time frame: Baseline, Week 5
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5
Time frame: Baseline, Week 5
Plan to share: No
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