Biomarker Discovery for Suicide Precision Circuit Therapeutics

NCT07723066 | Not Yet Recruiting

• 1 other identifier: 2025P003372
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Suicidal Thoughts and Behaviors; Major Depressive Episode (MDE)

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Suicidal Ideation; Behavior

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Central Study Contacts

Joan Camprodon, MD, PhD, MPH

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Neuropsychiatry and Interventional Psychiatry

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share