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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04606875
Other study ID # Campbell Neuro 001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2020
Est. completion date February 13, 2021

Study information

Verified date October 2020
Source Therapeutic Solutions International
Contact Famela Ramos
Phone 619 246 9179
Email famela8@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 13, 2021
Est. primary completion date January 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Therapeutic Solutions International Oceanside California

Sponsors (1)

Lead Sponsor Collaborator
Therapeutic Solutions International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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