Last reviewed · How we verify
NCT06752616
Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry
Phase 2/Phase 3 trial testing Sublingual Dexmedetomidine in Agitation in 132 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Lone Baandrup |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 30 December 2024 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Sublingual Dexmedetomidine — full drug profile →
- Buccal midazolam — full drug profile →
- Oral lorazepam
Conditions studied
- Agitation — all drugs for Agitation →
Sponsor
Lone Baandrup
Who can join
Adults 18 to 64, any sex, with Agitation. 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.
-
The Excited Component of the Positive and Negative Syndrome Scale (PEC)
Time frame: 60 minutes
The Excited Component of the Positive and Negative Syndrome Scale (PEC) consists of 5 clinician-rated items associated with agitation from the Positive and Negative Syndrome Scale (PANSS). Scores range from 5 to 35. Higher is worse.
Sponsor's own description
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06752616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sublingual Dexmedetomidine
Trials testing the same drug.
- NCT06192615 — Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) · Phase 3 · recruiting
- NCT04237532 — Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment · Phase 2, PHASE3 · completed
Other recruiting trials for Agitation
Currently open trials in the same condition.
- NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
- NCT05522647 — Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients. · recruiting
- NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
Other Lone Baandrup trials
Trials by the same sponsor.
- NCT06062953 — Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia · Phase 2, PHASE3 · recruiting
- NCT04105231 — Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use · Phase 2 · active not recruiting
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 NCT06752616 (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 Lone Baandrup
- Last refreshed: 30 December 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/NCT06752616.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing