Acute Agitation in Emergency Psychiatry
Recruiting
Phase 2
Phase 3
Interventional Study
Agitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 64
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 132 (estimated)
- Sponsor
- Lone Baandrup · Other
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About This Trial
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18-64 years
* Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms
* Total score of ≥14 on the PANSS Excited Component (PEC)
* A score ≥4 on at least 1 of the 5 items of the PEC
* Informed consent obtained prior t…
Contacts