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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Thoughts and Behaviors; Major Depressive Episode (MDE)

Detailed Description

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 (Estimated): 60

Contacts and Locations

• Study Contact: Name: Joan Camprodon, MD, PhD, MPH; Phone Number: 617-726-5340; Email: JCAMPRODON@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	Baseline and post-treatment assessment (approximately 2-8 weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Behavior
• Other Study ID Numbers: 2025P003372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No