Correlation of Campbell Score With Suicidal Ideation

Sponsor
Therapeutic Solutions International (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04606875
Collaborator
(none)
30
1
3.3
9.1

Study Details

Study Description

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

  1. 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

  1. 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 Phase
  • Diagnostic Test: Campbell Score

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Nov 5, 2020
Anticipated Primary Completion Date :
Jan 13, 2021
Anticipated Study Completion Date :
Feb 13, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Assessment of Campbell Score [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 [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Therapeutic Solutions International Oceanside California United States 92056

Sponsors and Collaborators

  • Therapeutic Solutions International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Therapeutic Solutions International
ClinicalTrials.gov Identifier:
NCT04606875
Other Study ID Numbers:
  • Campbell Neuro 001
First Posted:
Oct 28, 2020
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Therapeutic Solutions International
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2020