CClinicalTrials.gg
Not yet recruitingNCT07568054Updated Sep 3, 2026

Neural Correlates of Suicidal Behavior in Youth

An interventional study of CAMS in Suicidal Ideation, Suicide Attempt and Suicidal Behavior, sponsored by The Cleveland Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
14 Years to 24 Years
Sex
All
01

Study 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.

Read the detailed description

This research study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," is designed to advance understanding of the neurobiological and clinical mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults aged 14-24 years. Suicide is one of the leading causes of death in this age group, and current clinical tools are often insufficient for accurately predicting risk or preventing future suicide attempts. A major limitation in the field is the lack of objective biological markers that can identify individuals at highest risk and guide targeted treatment.

The overarching goal of this study is to investigate how brain structure, function, and neurochemistry differ across varying levels of suicide risk, and how these features change following an evidence-based suicide-specific psychotherapy. The study combines advanced neuroimaging techniques with detailed clinical assessments to provide a comprehensive, multimodal understanding of suicidality.

Participants will be divided into three groups (n=60 total, 20 per group):

  • High Risk (HR): Individuals recently hospitalized following a suicide attempt and with a history of multiple attempts.
  • Medium Risk (MedR): Individuals with chronic suicidal ideation lasting at least one year but no history of attempts.
  • Minimal Risk (MinR): Healthy controls with no history of suicidal ideation or behavior and no psychiatric treatment.

All participants will complete baseline assessments including structured psychiatric interviews and validated rating scales measuring depression, hopelessness, suicidal ideation, and overall functioning. Neuroimaging will include magnetoencephalography (MEG) to measure real-time brain activity and MRI-based techniques such as resting-state functional MRI (rsfMRI), magnetic resonance spectroscopy (MRS), and task-based imaging focused on episodic future thinking.

The study specifically targets brain regions and networks implicated in suicide risk, including the anterior cingulate cortex (ACC), anterior insula (AI), salience network, and default mode network. These regions are associated with emotional regulation, self-referential thinking, and processing of future-oriented thoughts. Prior research suggests that abnormalities in these systems-such as altered connectivity, metabolic imbalances (e.g., glutamate levels), and disrupted electrophysiological patterns-may contribute to suicidal ideation and behavior.

A key component of the study is the examination of hopelessness, which is considered a central psychological factor in suicidality and a potential proxy for suicide risk. The study will explore how neural markers correlate with levels of hopelessness and how these relationships differ across risk groups.

Following baseline assessments, participants in the high-risk group will receive the Collaborative Assessment and Management of Suicidality (CAMS) intervention. CAMS is a structured, evidence-based psychotherapy that emphasizes collaboration between the patient and clinician to identify the personal drivers of suicidal thoughts. It uses the Suicide Status Form (SSF) to guide assessment, treatment planning, and ongoing monitoring. Core principles of CAMS include empathy, collaboration, honesty, and a direct focus on suicidality. Treatment typically involves weekly sessions and continues until the patient demonstrates reduced suicide risk and improved coping.

After completing CAMS therapy (typically 3-12 sessions), high-risk participants will undergo repeat neuroimaging and clinical assessments. This pre-post design allows researchers to evaluate how psychotherapy influences brain function, connectivity, and neurochemical markers, as well as clinical symptoms such as hopelessness and suicidal ideation.

The study has three primary aims:

  1. To identify electrophysiological markers of suicidality using MEG, including oscillatory dynamics and network connectivity patterns.
  2. To examine neuroimaging correlates of suicide risk, including functional connectivity, brain activation during future thinking tasks, and metabolic measures obtained through MRS.
  3. To assess the effects of CAMS therapy on brain function and neurochemistry in high-risk individuals.

In addition to the main study, qualitative focus groups will be conducted with adolescents participating in an intensive outpatient program. These groups aim to gather patient perspectives on barriers to research participation and treatment engagement, helping to improve study design and clinical care approaches.

Data analysis will include comparisons across risk groups using statistical models such as ANOVA and regression analyses, as well as correlation analyses to examine relationships between clinical measures and neurobiological variables. Longitudinal analyses will evaluate changes following CAMS therapy.

The potential impact of this study is significant. By identifying objective neural markers associated with suicide risk and treatment response, the research could improve early detection of high-risk individuals and guide personalized interventions. Understanding how CAMS therapy produces changes in the brain may also help refine and optimize treatment strategies for suicidal youth.

Ultimately, this study aims to bridge the gap between clinical psychiatry and neuroscience, contributing to more effective, biologically informed approaches to suicide prevention in young people.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
14 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    High risk (HR)

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

    Behavioral: CAMS

  • No intervention
    Medium risk (MedR)

    patients with 1 year history of SI with no attempts

  • No intervention
    Minimal risk (MinR)

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

Interventions

  • BehavioralCAMS

    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).

05

What researchers measure

Primary outcomes

  1. MRS & suicidality

    To investigate the effect of changes in Suicide Status Form (SSF) scores (low severity 1-5 high severity) as a result of CAMS therapy on Glx levels.

    Time frame: 5 years

Secondary outcomes

  1. MRS & suicidality

    To investigate the effect of changes in Suicide Status Form (SSF) scores (low severity 1-5 high severity) as a result of CAMS therapy on myo inositol levels.

    Time frame: 5 years

Other outcomes

  1. MRS & Optimism

    To investigate the effect of changes in the Optimism and Hope scores (lowest severity 14-56 highest severity) as a result of CAMS therapy on Glx levels.

    Time frame: 5 years

  2. MRS & Optimism

    To investigate the effect of changes in the Optimism and Hope scores (lowest severity 14-56 highest severity) as a result of CAMS therapy on myo inositol levels.

    Time frame: 5 years

  3. MRS & Hopelessness

    To investigate the effect of changes in the Beck Hopelessness scores (lowest severity 0-20 highest severity) as a result of CAMS therapy on Glx levels.

    Time frame: 5 years

  4. MRS & Hopelessness

    To investigate the effect of changes in the Beck Hopelessness scores (lowest severity 0-20 highest severity) as a result of CAMS therapy on myo-inositol levels.

    Time frame: 5 years

  5. MEG & Suicidality

    To investigate the changes of Baseline Suicide Status Form (SSF) scoring (low severity 1-5 high severity) before and after CAMS on MEG measures of the connectivity and spectral power in the salience network.

    Time frame: 5 years

  6. MEG & Optimism

    To investigate the changes in the Optimism and Hope scale lowest severity (14-56 highest severity) from baseline to post CAMS on MEG measures of the connectivity and spectral power in the salience network.

    Time frame: 5 years

  7. MEG & Hopelessness

    To investigate the changes in the Beck Hopelessness Scale (lowest severity 0-20 highest severity) from baseline to post CAMS on MEG measures of the connectivity and spectral power in the salience network.

    Time frame: 5 years

06

Study locations

1 site
  • The Cleveland Clinic
    Cleveland, Ohio 44195, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07568054
Lead sponsor
The Cleveland Clinic
Collaborators
MQ Mental Health Research
Responsible party
Tatiana Falcone, MD (Vice Chair of Research Behavioral Health and Neurological Science, Child and Adolescent Psychiatrist, Assistant Professor of Medicine, Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
May 5, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Sep 1, 2031 (estimated)
Completion
Oct 1, 2031 (estimated)
Last update
Sep 3, 2026

Study contacts

Christina A Deisz, LISW-S
Contact
deiszc@ccf.org
(440) 225-6193
Tatiana Falcone, M.D.
Contact
falcont1@ccf.org
(216) 444-7459
Tatiana Falcone, M.D.
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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