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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

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Suicidal Ideation Diagnostic Test: Campbell Score

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Campbell Score as a Means of Predicting Suicidal Ideation High Risk Patients
Estimated Study Start Date : November 5, 2020
Estimated Primary Completion Date : January 13, 2021
Estimated Study Completion Date : February 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Groups and Cohorts
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Group/Cohort Intervention/treatment
Control Group
Subjects will have no personal or family psychiatric history and no suicide attempts.
 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.
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)
 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.
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)
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04606875


Contacts
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Contact: Famela Ramos 619 246 9179 famela8@gmail.com

Locations
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United States, California
Therapeutic Solutions International Recruiting
Oceanside, California, United States, 92056
Contact: Famela Ramos    619-246-9179    famela8@gmail.com   
Principal Investigator: James Veltmeyer, MD         
Sponsors and Collaborators
Therapeutic Solutions International
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Therapeutic Solutions International
ClinicalTrials.gov Identifier: NCT04606875    
Other Study ID Numbers: Campbell Neuro 001
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Therapeutic Solutions International:
interleukin-6, suicidal ideation, immunology
Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms