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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01992445
Other study ID # 20133770
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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