Suicidal IdeationNCT04606875
Correlation of Campbell Score With Suicidal Ideation
An observational study of Suicidal Ideation, run by Therapeutic Solutions International at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Campbell Score
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 13 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Therapeutic Solutions International
Oceanside, California, 92056
Famela Ramos, 619-246-9179, famela8@gmail.com
James Veltmeyer, MD
About this study
Official title: 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:
Read more
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
- Being tested
- Campbell Score
- Keywords
- interleukin-6, suicidal ideation, immunology
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Subjects will have no personal or family psychiatric history and no suicide attempts. Receives: 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) Receives: 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) Receives: Diagnostic Test: Campbell Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 week to compare the records with the Campbell Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start5 Nov 2020 (estimated)
- Primary completion13 Jan 2021 (estimated)
- Study completion13 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therapeutic Solutions International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606875
- Sponsor's protocol ID
- Campbell Neuro 001
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Campbell Score as a Means of Predicting Suicidal Ideation High Risk Patients
- ClinicalTrials.gov ID
- NCT04606875
- Acronym / sponsor ID
- Campbell Neuro 001
- Conditions
- Suicidal Ideation
- Keywords
- interleukin-6, suicidal ideation, immunology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Therapeutic Solutions InternationalIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (estimated)
- Primary completion
- 13 Jan 2021 (estimated)
- Study completion
- 13 Feb 2021 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: Campbell ScoreSubjects will have no personal or family psychiatric history and no suicide attempts. |
| Patients with Suicidal Ideation and Low Acquired Capability | – | Diagnostic Test: Campbell ScoreSubjects 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 | – | Diagnostic Test: Campbell ScoreSubjects will have suicidal ideation (Hamilton Depression Rating Scale suicide item >2) and reported high acquired capability for suicide (Acquired Capability for Suicide Scale >60) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Campbell ScoreThe 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. | Diagnostic test | Control Group, Patients with Suicidal Ideation and High Acquired Capability, Patients with Suicidal Ideation and Low Acquired Capability |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Ideation, run by Therapeutic Solutions International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Famela Ramos (619 246 9179, famela8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Campbell Score (time frame: 1 week to compare the records with the Campbell Score). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.