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Correlation of Campbell Score With Suicidal Ideation

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ClinicalTrials.gov Identifier: NCT04606875
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Therapeutic Solutions International

Tracking Information
First Submitted Date October 22, 2020
First Posted Date October 28, 2020
Last Update Posted Date October 28, 2020
Estimated Study Start Date November 5, 2020
Estimated Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2020)
  • Assessment of Campbell Score [ Time Frame: 1 week to compare the records with the Campbell Score ]
    Campbell Score will be compared between healthy volunteers, patients with suicidal idea with low acquired capability for suicide, and patients with suicidal idea with high acquired capability for suicide.
  • Assessment of Correlation between Campbell Score and Beck Scale for Suicidal Ideation [ Time Frame: 1 week to compare the records with the Campbell Score ]
    Campbell Score will be compared to scoring of patients on the Beck Scale for Suicidal Ideation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation of Campbell Score With Suicidal Ideation
Official Title Assessment of Campbell Score as a Means of Predicting Suicidal Ideation High Risk Patients
Brief Summary

The Campbell Score is a blood based means of assessing molecules believed to be associated with suicidal ideation and in some cases successful suicide.

The current clinical trial will assess the Campbell Score in 3 groups:

Group 1: 10 patients with no personal or family psychiatric history and no suicide attempts.

Group 2: 10 patients with suicidal ideation (Hamilton Depression Rating Scale suicide item >2) and reported low acquired capability for suicide (Acquired Capability for Suicide Scale <20).

Group 3: 10 patients with suicidal ideation (Hamilton Depression Rating Scale suicide item >2) and reported high acquired capability for suicide (Acquired Capability for Suicide Scale >60).

The goal of the study is to confirm efficacy of Campbell Score in identifying patients with high suicidal ideation potential.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will comprise of 10 healthy volunteers, as well as 20 patients with suicidal ideations. 10 of the patients will have low acquired capability for suicide, and 10 will have high acquired capability for suicide.
Condition Suicidal Ideation
Intervention Diagnostic Test: Campbell Score
The Campbell Score is a blood based assessment of inflammatory and immunologically associated markers that is currently in development as a means of predicting suicidal ideations.
Study Groups/Cohorts
  • Control Group
    Subjects will have no personal or family psychiatric history and no suicide attempts.
    Intervention: Diagnostic Test: Campbell Score
  • Patients with Suicidal Ideation and Low Acquired Capability
    Subjects will have suicidal ideation (Hamilton Depression Rating Scale suicide item >2) and reported low acquired capability for suicide (Acquired Capability for Suicide Scale <20)
    Intervention: Diagnostic Test: Campbell Score
  • Patients with Suicidal Ideation and High Acquired Capability
    Subjects will have suicidal ideation (Hamilton Depression Rating Scale suicide item >2) and reported high acquired capability for suicide (Acquired Capability for Suicide Scale >60)
    Intervention: Diagnostic Test: Campbell Score
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 22, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 13, 2021
Estimated Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Capability of giving informed consent
  • Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study.
  • Be diagnosed with Suicide ideation/attempts/gestures

Exclusion Criteria:

- Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Famela Ramos 619 246 9179 famela8@gmail.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04606875
Other Study ID Numbers Campbell Neuro 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Therapeutic Solutions International
Study Sponsor Therapeutic Solutions International
Collaborators Not Provided
Investigators Not Provided
PRS Account Therapeutic Solutions International
Verification Date October 2020