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NCT05658510
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
Phase 3 trial testing BXCL501 in Agitation,Psychomotor in 452 participants. Completed in 15 August 2025.
15 August 2025
Quick facts
| Lead sponsor | BioXcel Therapeutics Inc |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 452 |
| Start date | 21 November 2022 |
| Primary completion | 15 August 2025 |
| Estimated completion | 15 August 2025 |
| Sites | 24 locations across United States |
Drugs / interventions tested
- BXCL501 — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Agitation,Psychomotor — all drugs for Agitation,Psychomotor →
- Bipolar I Disorder — all drugs for Bipolar I Disorder →
- Bipolar II Disorder — all drugs for Bipolar II Disorder →
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
BioXcel Therapeutics Inc — full company profile →
Who can join
Adults 18 to 75, any sex, with Agitation,Psychomotor or Bipolar I Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05658510
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BXCL501
Trials testing the same drug.
- NCT05665088 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) · Phase 3 · terminated
- NCT05271552 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) · Phase 3 · completed
- NCT05276830 — An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia · Phase 2 · terminated
- NCT05313386 — Study of BXCL501 In Agitation Associated With Delirium in ICU Patients · Phase 2 · withdrawn
Other recruiting trials for Agitation,Psychomotor
Currently open trials in the same condition.
- NCT05783505 — A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use · NA · recruiting
- NCT05765162 — Safe Brain Initiative, Operationalizing Precision Anaesthesia · recruiting
- NCT03926520 — Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) · NA · recruiting
Other BioXcel Therapeutics Inc trials
Trials by the same sponsor.
- NCT07116694 — Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder · Phase 2 · completed
- NCT06041646 — Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder · Phase 4 · completed
- NCT05665088 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) · Phase 3 · terminated
- NCT05271552 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) · Phase 3 · completed
- NCT05276830 — An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia · Phase 2 · terminated
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 NCT05658510 (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 BioXcel Therapeutics Inc
- Last refreshed: 18 September 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/NCT05658510.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing