NCT04606875

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2021

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 22, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

interleukin-6, suicidal ideation, immunology

Outcome Measures

Primary Outcomes (2)

  • Assessment of 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

    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

Study Arms (3)

Control Group

Subjects will have no personal or family psychiatric history and no suicide attempts.

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)

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)

Diagnostic Test: Campbell Score

Interventions

Campbell ScoreDIAGNOSTIC_TEST

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.

Control GroupPatients with Suicidal Ideation and High Acquired CapabilityPatients with Suicidal Ideation and Low Acquired Capability

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutic Solutions International

Oceanside, California, 92056, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 28, 2020

Study Start

November 5, 2020

Primary Completion

January 13, 2021

Study Completion

February 13, 2021

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations