Biomarker Discovery for Suicide Precision Circuit Therapeutics
20. juli 2026 opdateret af: Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
This is a prospective observational biomarker study assessing changes in clinical, behavioral, neuroimaging, and neurophysiological measurer following ketamine/esketamine or electroconvulsive therapy (ECT) in adults with suicidal thoughts or behaviors.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
Suicide remains a major public health challenge, and there is a critical need for objective biomarkers that can improve understanding of suicide risk and guide the development of more effective treatments.
Participants with a mood disorder and moderate to severe suicidal thoughts or behaviors will undergo clinical assessments, behavioral testing, magnetic resonance imaging (MRI), electroencephalography (EEG), and digital monitoring before and after an acute course of ECT or ketamine/esketamine treatment. The study will examine how changes in brain circuits, physiology, behavior, and digital measures relate to improvement in suicidal symptoms. Findings from this study may help identify biomarkers that predict treatment response and support the future development of personalized interventions for suicide prevention.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Joan Camprodon, MD, PhD, MPH
- Telefonnummer: 617-726-5340
- E-mail: JCAMPRODON@mgh.harvard.edu
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adults aged 18-65 years with a major depressive episode associated with Major Depressive Disorder or Bipolar Disorder and moderate to severe suicidal thoughts or behaviors who are receiving electroconvulsive therapy (ECT), intravenous ketamine, or intranasal esketamine as part of routine clinical care within the Mass General Brigham Health System.
Participants are enrolled into an observational biomarker study evaluating clinical, behavioral, neuroimaging, and neurophysiological correlates of treatment response.
Beskrivelse
Inclusion Criteria:
- Adults aged 18 to 65 years
- Diagnosis of a major depressive episode associated with Major Depressive Disorder or Bipolar Disorder
- Presence of moderate to severe suicidal thoughts or behaviors, as determined by the Beck Scale for Suicide Ideation (BSSI)
- Scheduled to receive an acute treatment course of electroconvulsive therapy (ECT), intravenous ketamine, or intranasal esketamine as part of routine clinical care
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Neurological disorders, particularly conditions associated with known structural brain lesions
- Inability to meet MRI safety requirements
- Current alcohol dependence
- Active symptoms of non-alcohol psychoactive substance withdrawal
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Ketamine/Esketamine
Participants with a major depressive episode and moderate to severe suicidal thoughts or behaviors who are scheduled to receive intravenous ketamine or intranasal esketamine as part of routine clinical care.
Treatment is determined by the clinical care team and is not assigned by the study.
Participants complete clinical, behavioral, MRI, and EEG assessments before and after treatment.
|
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Electroconvulsive Therapy (ECT)
Participants with a major depressive episode and moderate to severe suicidal thoughts or behaviors who are scheduled to receive an acute course of electroconvulsive therapy (ECT) as part of routine clinical care.
Treatment is determined by the clinical care team and is not assigned by the study.
Participants complete clinical, behavioral, MRI, and EEG assessments before and after treatment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Suicidal Ideation Severity
Tidsramme: Baseline and post-treatment assessment (approximately 2-8 weeks)
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Change in suicidal ideation severity from pre-treatment baseline to completion of the acute treatment course, measured using the Beck Scale for Suicide Ideation (BSSI).
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Baseline and post-treatment assessment (approximately 2-8 weeks)
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Change in Functional Brain Connectivity
Tidsramme: Baseline and post-treatment assessment (approximately 2-8 weeks)
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Change in functional connectivity within neural circuits implicated in suicidal thoughts and behaviors, measured using resting-state functional magnetic resonance imaging (fMRI).
Analyses will focus on circuit-level biomarkers associated with treatment response.
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Baseline and post-treatment assessment (approximately 2-8 weeks)
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|
Change in Neurophysiological Circuit Activity
Tidsramme: Baseline and post-treatment assessment (approximately 2-8 weeks)
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Change in neurophysiological measures associated with suicidal thoughts and behaviors, assessed using high-density electroencephalography (EEG).
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Baseline and post-treatment assessment (approximately 2-8 weeks)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2029
Studieafslutning (Anslået)
31. august 2030
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025P003372
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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