Biomarker Discovery for Suicide Precision Circuit Therapeutics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Suicidal Thoughts and Behaviors, Major Depressive Episode (MDE). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Change in Suicidal Ideation Severity [Time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)]
- Change in Functional Brain Connectivity [Time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)]
- Change in Neurophysiological Circuit Activity [Time frame: Baseline and post-treatment assessment (approximately 2-8 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07723066 · 2025P003372