Neural Correlates of Suicidal Behavior in Youth

NCT07568054 | Not Yet Recruiting

• 1 other identifier: IRB 25-894
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," aims to better understand the brain mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults (ages 14-24). Suicide is a leading cause of death in this population, and current clinical approaches often fail to accurately predict or prevent suicidal behavior. This study seeks to identify objective neurobiological markers associated with suicide risk and treatment response. Participants will be divided into three groups: (1) high-risk individuals recently hospitalized following a suicide attempt, (2) medium-risk individuals with chronic suicidal ideation but no attempts, and (3) low-risk healthy controls. All participants will undergo advanced neuroimaging, including magnetoencephalography (MEG) and magnetic resonance imaging (MRI), along with comprehensive psychiatric assessments. The study focuses on brain regions and networks implicated in suicidality, including the anterior cingulate cortex and salience network, as well as neurochemical markers such as glutamate. It also examines electrophysiological activity and functional connectivity patterns associated with suicidal thoughts and behaviors. High-risk participants will receive an evidence-based psychotherapy called the Collaborative Assessment and Management of Suicidality (CAMS). This therapeutic approach emphasizes collaboration between patient and clinician to identify and address the underlying drivers of suicidal thoughts, with a focus on increasing hope and reducing psychological distress. Neuroimaging and clinical assessments will be repeated after completion of CAMS to evaluate treatment-related changes. The study's primary goals are to:

• Identify neural and electrophysiological correlates of suicide risk.
• Distinguish biological differences between individuals with suicidal ideation and those who have attempted suicide.
• Determine how CAMS therapy affects brain function and neurochemistry. By integrating clinical and neurobiological data, this research aims to improve understanding of suicidality, enhance risk prediction, and inform more effective, personalized interventions for at-risk youth.

Conditions

Suicidal Ideation; Suicide Attempt; Suicidal Behavior; Depression / Major Depressive Disorder; Hopelessness; Neurobiological

Keywords

Suicidal ideation; Suicide attempt; Suicidal behavior; Youth suicide; Depression; Hopelessness; CAMS therapy; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• MEG and suicidality

  Measure the difference on the connectivity within the salience network. This will be quantified using phase-locking values (PLV) across different frequency bands in 10-second intervals. The average PLV-based connectivity will serve as an electrophysiological biomarker for correlation with SI. To test hypothesis 1, salience network connectivity will be compared between groups using ANOVA.

  5 years

Secondary Outcomes (1)

• Suicidality & network connectivity

  5 years

Other Outcomes (1)

• CAMS on MEG and MRS metabolites

  5 years

Study Arms (3)

High risk (HR)

ACTIVE COMPARATOR

patients discharged within 1 week from the hospital for a SA and with a history of 2 previous SAs

Behavioral: CAMS

Medium risk (MedR)

NO INTERVENTION

patients with 1 year history of SI with no attempts

Minimal risk (MinR)

NO INTERVENTION

age-matched controls with no prior history of SI or behavior, not taking any psychotropic medication and no family history of suicide

Interventions

CAMS BEHAVIORAL

CAMS weekly sessions will be started immediately as an inpatient at the start of the study for the high risk participants. CAMS will be continued weekly after the patient is discharged and followed up as an outpatient. Weekly CAMS sessions will be terminated after the subject, as an outpatient, has three consecutive outpatient CAMS sessions with an overall risk \< 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).

High risk (HR)

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects must be 14-24 years old
• Subjects must be:
• High Risk Subjects: Psychiatrically admitted due to a suicide attempt or history of 2 previous suicide attempts
• Medium Risk Subjects: Suicide ideation for the past year with no suicide attempt
• Minimal Risk Subjects: No previous history of suicidal ideation or behavior, not taking any psychiatric history or medication, and no family history of suicide
• Subjects must have the ability to understand and the willingness to sign a written informed consent/assent document
• Subjects must be English speaking

You may not qualify if:

• Subjects with known history of Autism Spectrum Disorder; non-verbal patients
• Subjects with moderate or severe intellectual disability (IQ less than 70 and those patients in special education classes full time)
• Subjects with Schizophrenia or history of any type of psychosis including mood related psychosis and brief reactive psychosis
• Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (subjects prescribed amphetamines for the management of ADHD will not be excluded)
• Subjects with a history of moderate or severe substance or alcohol use per DSM-5 criteria in the past 6 months
• Subjects who are currently pregnant or breastfeeding
• Subjects in custody of Children's Services
• Subjects with recent bone, tendon, spine or joint surgery
• Subjects with recent metallic dental implants
• Subjects weighing less than 30 kg or more than 200 kg

Sponsors & Collaborators

• The Cleveland Clinic: lead
• MQ Mental Health Research: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Tatiana Falcone, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina A Deisz, LISW-S

CONTACT

(440) 225-6193; deiszc@ccf.org

Tatiana Falcone, M.D.

CONTACT

(216) 444-7459; falcont1@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Cleveland Clinic

Model Details: This study uses a parallel-group design with three cohorts (high, medium, and minimal suicide risk) to examine neurobiological correlates of suicidality in youth (ages 14-24). All participants undergo baseline clinical assessments and neuroimaging (MEG, MRI, fMRI, MRS) to compare brain function, connectivity, and neurochemistry across risk groups. The high-risk group additionally receives the Collaborative Assessment and Management of Suicidality (CAMS) intervention and completes follow-up assessments after treatment. This allows for both cross-sectional comparisons between groups and longitudinal evaluation of treatment-related changes. The study aims to identify biomarkers of suicide risk and predictors of therapeutic response.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 5, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)