Suicidal Thought and Biological Markers

Completed

• Conditions: Suicidal Intention

• Registration Number: NCT01992445
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.

Detailed Description

The purpose of this study is to develop a predictive model that includes Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

oBe able to understand the requirements of the study and provide written informed consent to participate in this study. Signed and dated informed consent will be obtained from each patient before participation in the study, oHave provided written authorization for the use and disclosure of their protected health information, oBe 13 years of age or older, oBe diagnosed with: oSuicide ideation/attempts/gestures, or oNon-suicidal and having other mental disorders, oNon-mentally ill, and non-suicidal controls, oSpeak English as the primary language in the home, oAgree to abide by the study protocol and its restrictions and be able to complete all aspects of the study.

Exclusion Criteria

oSignificant unstable medical condition that may obscure the scientific interpretability of the study or unduly increase the risks of the protocol, oAnticipated inability to attend follow-up phone interview, oPatients whose level of consciousness precludes consent and research assessments, oPatients unable to assent because of severe mental retardation, oPatients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol, oFor control patients a diagnosis of depression or another non-mental illness, or a history of suicidal behavior or suicidal attempt, oPatients who are unwilling to provide the DNA sample.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Columbia Suicide Severity Rating Scale	1 month	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Acoustic analysis of voice	1 month	Voice recording
Video analysis	Baseline	Video recording
DNA analysis	Baseline	DNA analysis

Trial Locations

Locations (3)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Princeton Community Hospital; 🇺🇸 Princeton, West Virginia, United States

CCHMC; 🇺🇸 Cincinnati, Ohio, United States