Suicidal Thought and Biological Markers

Suicidal Intention Clinical Trial

— STM  

Official title:

Suicidal Thought and Biological Markers: A Prospective Multicenter Study Validating Verbal, Non-verbal and Genetic Methods to Assess Suicidal Intent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992445
• Other study ID #: 20133770
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: May 19, 2016
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicidal Intention

Locations

Country	Name	City	State
United States	CCHMC	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Princeton Community Hospital	Princeton	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia Suicide Severity Rating Scale	Questionnaire	1 month
Secondary	Acoustic analysis of voice	Voice recording	1 month
Secondary	Video analysis	Video recording	Baseline
Secondary	DNA analysis	DNA analysis	Baseline