Biomarker Discovery for Suicide Precision Circuit Therapeutics
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Ketamine/Esketamine
Group B: Electroconvulsive Therapy (ECT)
Trial outcomes
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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