Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Neural Correlates of Suicidal Behavior in Youth

29. april 2026 opdateret af: Tatiana Falcone, MD, The Cleveland Clinic

Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Tatiana Falcone, M.D.
  • Telefonnummer: (216) 444-7459
  • E-mail: falcont1@ccf.org

Undersøgelse Kontakt Backup

  • Navn: Christina A Deisz, LISW-S
  • Telefonnummer: (440) 225-6193
  • E-mail: deiszc@ccf.org

Studiesteder

    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: High risk (HR)
patients discharged within 1 week from the hospital for a SA and with a history of 2 previous SAs
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).
Ingen indgriben: Medium risk (MedR)
patients with 1 year history of SI with no attempts
Ingen indgriben: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MEG and suicidality
Tidsramme: 5 years
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Suicidality & network connectivity
Tidsramme: 5 years

To study the relationship of suicidality with network connectivity, activation during an episodic future thinking task, and MRS measures. To test this, activation strength of the ventral medial prefrontal cortex will be tested using a between-group ANOVA.

Using the MRS voxel locations as a guide, functional connectivity between the pregenual anterior cingula cortex and anterior insula will be calculated. Glutamine and myo-inositol levels and rsfMRI strength will be compared using between-group ANOVAs.

5 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CAMS on MEG and MRS metabolites
Tidsramme: 5 years
To investigate the the changes of Baseline SSF scoring before and after CAMS on MEG and MRS metabolites in the HR group. MRS measures of Glutamine and myo-inositol and MEG salience network measures will be tested using a repeated measures ANOVA. To test this, the change in Glutamine and myo-inositol levels will be calculated and correlated with measures of hopelessness and SI using the Beck Hopelessness Scale and Optimism and Hope scale along with the Beck SSI.
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Tatiana Falcone, M.D., The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

13. april 2026

Primær færdiggørelse (Anslået)

1. september 2031

Studieafslutning (Anslået)

1. oktober 2031

Datoer for studieregistrering

Først indsendt

10. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Selvmordstanker

Kliniske forsøg med CAMS

Abonner