ClinicalTrials.gg
Not yet recruitingNCT07723066Updated Jul 23, 2026

Biomarker Discovery for Suicide Precision Circuit Therapeutics

An observational study in Suicidal Thoughts and Behaviors and Major Depressive Episode (MDE), sponsored by Massachusetts General Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Suicidal Thoughts and Behaviors
  • Major Depressive Episode (MDE)
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In context

Suicidal Ideation

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 60 is below the median of 143 across 74 observational studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07723066
Responsible party
Joan A Camprodon, MD MPH PhD (Chief, Division of Neuropsychiatry and Interventional Psychiatry, Massachusetts General Hospital) — Principal investigator
First posted
Jul 23, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jul 2029 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Jul 23, 2026

Study contacts

Joan Camprodon, MD, PhD, MPH
Contact
JCAMPRODON@mgh.harvard.edu
617-726-5340

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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