Biomarker Discovery for Suicide Precision Circuit Therapeutics

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.

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Key information

Conditions

Suicidal Thoughts and Behaviors Behavior Behavioral Symptoms Major Depressive Episode (MDE) Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in Suicidal Ideation Severity

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

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).
Change in Functional Brain Connectivity

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

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.
Change in Neurophysiological Circuit Activity

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Camprodon, MD, PhD, MPH

CONTACT

[email protected]

617-726-5340

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Jul 23, 2026
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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