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Suicidal Thought and Biological Markers (STM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992445
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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

Condition or disease
Suicidal Intention

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.

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Study Type : Observational
Actual Enrollment : 375 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Suicidal Thought and Biological Markers: A Prospective Multicenter Study Validating Verbal, Non-verbal and Genetic Methods to Assess Suicidal Intent
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Group/Cohort
Suicidal
Other mental health
Control (non suicidal, non mental health)



Primary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale [ Time Frame: 1 month ]
    Questionnaire


Secondary Outcome Measures :
  1. Acoustic analysis of voice [ Time Frame: 1 month ]
    Voice recording

  2. Video analysis [ Time Frame: Baseline ]
    Video recording

  3. DNA analysis [ Time Frame: Baseline ]
    DNA analysis


Biospecimen Retention:   Samples With DNA
Buccal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency Department and inpatients
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992445


Locations
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United States, Ohio
CCHMC
Cincinnati, Ohio, United States, 45229
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, West Virginia
Princeton Community Hospital
Princeton, West Virginia, United States, 24740
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Study Director: John Pestian, PhD CCHMC
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01992445    
Other Study ID Numbers: 20133770
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Keywords provided by Children's Hospital Medical Center, Cincinnati:
suicide
suicidal intent
thought markers
Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms