What side effects are associated with this type of intervention?

Common treatments for psychomotor agitation, such as antipsychotics (e.g., risperidone, olanzapine, quetiapine), often have side effects including sedation, weight gain, metabolic syndrome, extrapyramidal symptoms (such as tremors and rigidity), and increased risk of cardiovascular events. Benzodiazepines, another class of medications used for agitation, can cause drowsiness, dizziness, dependency, and cognitive impairment. Mood stabilizers like valproate and lithium may lead to gastrointestinal disturbances, tremors, and potential toxicity requiring regular monitoring.

What prior FDA approvals exist?

FDA-approved treatments for psychomotor agitation often include antipsychotics and mood stabilizers. Antipsychotics such as risperidone, olanzapine, and quetiapine are frequently used due to their efficacy in managing agitation and related symptoms. Mood stabilizers like lithium and valproate are also employed to control agitation, particularly in patients with underlying mood disorders. These treatments align with the general approach of managing psychomotor agitation through pharmacotherapy aimed at stabilizing mood and reducing agitation.

What other types of research exist?

Promising novel alternatives for treating psychomotor agitation in 2024 include: 1) Remote Electrical Neuromodulation (REN), which has shown efficacy in alleviating episodic migraine pain and may have potential applications in agitation management. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which has been effective in acute migraine therapy and could be explored for agitation. 3) Single-pulse Transcranial Magnetic Stimulation (sTMS), which has been used for migraine with aura and may offer benefits for agitation. These treatments leverage neuromodulation techniques to potentially manage symptoms of psychomotor agitation.

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ED-TREAT for Eating Disorders

N/A

Waitlist Available

Led By Ambrose H. Wong, (203) 737-2489

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (age≥18) patients presenting to the YNHH ED during the pilot trial period

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ED-TREAT, a new tool in electronic health records that helps doctors in emergency rooms manage patient behavior. It focuses on patients at risk of becoming agitated and uses data to guide doctors in preventing agitation. The study aims to see if this tool can improve care quality and resource use.

Who is the study for?

This trial is for adults over 18 who might be at risk of psychomotor agitation or behavioral disorders. Participants should not need physical restraints upon arrival, must be alert and calm, speak English well enough to converse, and can verbally agree to join the study.

What is being tested?

The ED-TREAT approach is being tested against usual care methods to see if it's acceptable, can be followed as intended (fidelity), and works well in practice (feasibility) for early detection and treatment of agitation.

What are the potential side effects?

Since this trial focuses on a procedural intervention rather than a drug, specific side effects are not listed. However, there may be general risks associated with changes in management of agitation such as increased anxiety or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years or older and went to the YNHH ED during the trial period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of visits adherent to protocol

Secondary study objectives

System usability scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ED-TREATExperimental Treatment1 Intervention

EHR-embedded clinical decision support (CDS) tool designed to overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting.

Group II: Usual CareActive Control1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psychomotor agitation is commonly treated with antipsychotics, mood stabilizers, and benzodiazepines. Antipsychotics block dopamine receptors to reduce excessive dopaminergic activity. Mood stabilizers like lithium and valproate stabilize neuronal activity and reduce mood swings. Benzodiazepines enhance GABA's calming effect on the nervous system. These treatments are important as they address the neurochemical imbalances causing agitation, providing relief and improving quality of life for patients.

The efficacy of complementary therapies for agitation among older people in residential care facilities: a systematic review.Acute disturbed or violent behaviour: principles of treatment.