Recruiting

Adasuve

Sponsor:

Mt Sinai Hospital, Chicago

Code:

NCT02877108

Conditions

Agitation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

There is limited information on the best psychoactive medication to treat agitated patients in the emergency department. The intent of this study is to fill in knowledge gaps in the current practice of treating psychiatric patients in the acute care setting. The purpose of this study is to determine the best treatment for agitated psychiatric patients in the emergency department.

Conditions

Agitation

Study ID

NCT02877108

Start date

Apr, 2016

Status verified date

Aug, 2016

Completion date

Apr, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male and female patients at least 18 years of age and less than 65 years of age
  • Patients must be emergency department patients during time of study
  • All patients will be evaluated by the emergency physician to provide medical clearance- patients must be considered by the emergency physicians to be clinically agitated and to be clinically appropriate candidates for treatment with a medication
  • Each patient, or a surrogate, must understand the nature of the study and must sign an informed consent document
  • English speaking patients

Exclusion Criteria:

  • Female patients who are either pregnant or breast-feeding
  • Medically unstable patients
  • Patients who have delirium or dementia
  • Prisoners
  • Patients <18 or >65 years old
  • Non-English speaking patients
  • Contraindications for use for people with asthma, COPD, and other acute respiratory conditions

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Adasuve

These patients will receive Adasuve for treatment of agitation.

Haloperidol/Lorazepam

These patients will receive haloperidol/lorazepam for treatment of agitation.

Primary outcome measure

  • Reduction of Agitation as Measured by the PANSS-CC [ Time Frame: Three Hours ]

Central Contacts and Locations

Central contacts

Leslie Zun, MD

773-257-6957leslie.zun@sinai.org

Jamie Doucet, MPH

773-257-6130jamie.doucet@sinai.org

Locations

UCSD

Recruiting

La Jolla, California, United States, 92093

Contacts

Michael Wilson, MD

mpwilso1@outlook.com

Mount Sinai Hospital

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Jamie Doucet, MPH

773-257-6130jamie.doucet@sinai.org

More Information

Sponsor

Mt Sinai Hospital, Chicago

Last update posted

Aug 24, 2016

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mt Sinai Hospital, Chicago on 2016-08-24.