Acute Agitation in Emergency Psychiatry

NCT06752616 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2023-510201-18-00
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

Conditions

Agitation

Keywords

Emergency psychiatry

Outcome Measures

Primary Outcomes (1)

• The Excited Component of the Positive and Negative Syndrome Scale (PEC)

  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.

  60 minutes

Secondary Outcomes (6)

• PEC score earliest time with difference

  30, 60, 90, and 120 minutes

• Tranquillized or asleep

  30, 60, 90, and 120 minutes post-dose

• Physical restraint

  12 hours post-dose

• Mechanical restraint

  12 hours post-dose

• Rescue medication

  4-12 hours post-dose

Study Arms (3)

Sublingual dexmedetomidine

EXPERIMENTAL

Drug: Sublingual Dexmedetomidine

Buccal midazolam

EXPERIMENTAL

Drug: Buccal midazolam

Oral lorazepam

ACTIVE COMPARATOR

Drug: Oral lorazepam

Interventions

Sublingual Dexmedetomidine DRUG

Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs

Sublingual dexmedetomidine

Buccal midazolam DRUG

Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs

Buccal midazolam

Oral lorazepam DRUG

Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Oral lorazepam

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 to the occurrence of the emergency

You may not qualify if:

• Involuntary psychiatric admission according to the Danish Mental Health Act
• Female patients who are breastfeeding
• Female patients aged \<50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives
• Body weight \<50 kg
• Extreme obesity defined as estimated BMI≥ 40 kg/m2
• Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)
• The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)
• Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)
• Clinical suspicion of contraindications for one of the treatment arms
• Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment
• Known allergy to any of the study medications

Sponsors & Collaborators

• Lone Baandrup: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark: collaborator

Study Sites (1)

Mental Health Center Copenhagen, Bispebjerg

Copenhagen N, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lone Baandrup, MD, DMSc

  Mental Health Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Baandrup, MD, DMSc

CONTACT

00 45 91165903; lone.baandrup@regionh.dk

Marie Vang Jensen, MD

CONTACT

0045 6199 7358; marie.said.vang.jensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinic, clinical associate research professor

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)