Correlation of Campbell Score With Suicidal Ideation

October 22, 2020 updated by: Therapeutic Solutions International

Assessment of Campbell Score as a Means of Predicting Suicidal Ideation High Risk Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oceanside, California, United States, 92056
        • Recruiting
        • Therapeutic Solutions International
        • Contact:
        • Principal Investigator:
          • James Veltmeyer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week to compare the records with the Campbell Score
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
1 week to compare the records with the Campbell Score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Therapeutic Solutions International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 5, 2020

Primary Completion (Anticipated)

January 13, 2021

Study Completion (Anticipated)

February 13, 2021

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Campbell Neuro 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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