Suicidal Thoughts and BehaviorsNCT07723066
Biomarker Discovery for Suicide Precision Circuit Therapeutics
An observational study of Suicidal Thoughts and Behaviors and Major Depressive Episode (MDE), run by Massachusetts General Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Thoughts and Behaviors, Major Depressive Episode (MDE)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to 31 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Medical subject headings
- Suicidal Ideation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: Baseline and post-treatment assessment (approximately 2-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Thoughts and BehaviorsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723066
- Sponsor's protocol ID
- 2025P003372
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Discovery for Suicide Precision Circuit Therapeutics
- ClinicalTrials.gov ID
- NCT07723066
- Acronym / sponsor ID
- 2025P003372
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Thoughts and Behaviors and Major Depressive Episode (MDE), run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Camprodon, MD, PhD, MPH (617-726-5340, JCAMPRODON@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation Severity (time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.