Major Depressive Episode (MDE), Suicidal Thoughts and Behaviors
Conditions
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.
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.
Interventions
None listed
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicidal Ideation Severity | 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 | 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 | 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). |
Contacts
CONTACTJoan Camprodon, MD, PhD, MPH
Outcome results
None listed