Recruiting

Observational Study

Sponsor:

Therapeutic Solutions International

Code:

NCT04606875

Conditions

Suicidal Ideation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Campbell Score

Study Details

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.

Conditions

Suicidal Ideation

Study ID

NCT04606875

Start date

Nov 5, 2020

Status verified date

Oct, 2020

Completion date

Feb 13, 2021

Anticipated

Primary completion date

Jan 13, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Control Group

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

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)

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)

Interventions

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.

Primary outcome measure

  • Assessment of Campbell Score [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Famela Ramos

619 246 9179famela8@gmail.com

Locations

Therapeutic Solutions International

Recruiting

Oceanside, California, United States, 92056

Contacts

Famela Ramos

619-246-9179famela8@gmail.com

Principal Investigator:

James Veltmeyer, MD

More Information

Sponsor

Therapeutic Solutions International

Last update posted

Oct 28, 2020

Last verified

Oct, 2020

Keywords

  • interleukin-6, suicidal ideation, immunology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Therapeutic Solutions International on 2020-10-28.