Suicidal Intention Clinical Trial
— STMOfficial title:
Suicidal Thought and Biological Markers: A Prospective Multicenter Study Validating Verbal, Non-verbal and Genetic Methods to Assess Suicidal Intent
Verified date | May 2016 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.
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. |
Country | Name | City | State |
---|---|---|---|
United States | CCHMC | Cincinnati | Ohio |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Princeton Community Hospital | Princeton | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
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 |
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