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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03030924
Other study ID # STUDY00016409
Secondary ID 5K12HL133115
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2017
Est. completion date October 1, 2023

Study information

Verified date September 2022
Source Oregon Health and Science University
Contact David Sheridan, MD
Phone 5034941691
Email sheridda@ohsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.


Description:

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality or are admitted to an inpatient psychiatric adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends associated with suicidality noninvasively in an objective manner beyond subjective questionnaires currently available. Upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date October 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers
Gender All
Age group 13 Years to 19 Years
Eligibility Inclusion Criteria: - acute suicidality - consenting individual present in the emergency department Exclusion Criteria: - medical admission for an ingestion or other reason

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Solace
Noninvasive physiologic monitor

Locations

Country Name City State
United States OHSU Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
Oregon Health and Science University National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other past Medical History At enrollment
Other Medications Daily medications At enrollment and daily for one week after discharge
Primary Heart Rate Variability 1 week
Secondary Gender At enrollment
Secondary Age in Years at enrollment
Secondary Columbia Suicide Severity Score Numerical based on severity 1 week
Secondary PHQ-9 Depression Scale Numerical based on severity 1 week
Secondary Motion As detected by an accelerometer in Hz 1 week
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