NCT01992445

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

November 8, 2013

Last Update Submit

May 19, 2016

Conditions

Keywords

suicidesuicidal intentthought markers

Outcome Measures

Primary Outcomes (1)

  • Columbia Suicide Severity Rating Scale

    Questionnaire

    1 month

Secondary Outcomes (3)

  • Acoustic analysis of voice

    1 month

  • Video analysis

    Baseline

  • DNA analysis

    Baseline

Study Arms (3)

Suicidal

Other mental health

Control (non suicidal, non mental health)

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency Department and inpatients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CCHMC

Cincinnati, Ohio, 45229, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Princeton Community Hospital

Princeton, West Virginia, 24740, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • John Pestian, PhD

    CCHMC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations