Biomarker Discovery for Suicide Precision Circuit Therapeutics

N/ANot Yet RecruitingNCT07723066

Massachusetts General Hospital60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Suicidal Thoughts and Behaviors Major Depressive Episode (MDE)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Suicidal Ideation Severity

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).

Time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)

Change in Functional Brain Connectivity

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.

Time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)

Change in Neurophysiological Circuit Activity

Change in neurophysiological measures associated with suicidal thoughts and behaviors, assessed using high-density electroencephalography (EEG).

Time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)

Central Contacts

Joan Camprodon, MD, PhD, MPH

CONTACT

617-726-5340 JCAMPRODON@mgh.harvard.edu

Data from ClinicalTrials.gov

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