Clinical TrialSuicidalityNot yet recruiting

Biomarker Discovery for Suicide Precision Circuit Therapeutics

This prospective observational study (n=60) will assess biomarker changes in adults aged 18 to 65 years with a major depressive episode and moderate to severe suicidal thoughts or behaviours who are receiving routine clinical care with intravenous ketamine, intranasal esketamine, or an acute course of electroconvulsive therapy (ECT). The trial will evaluate whether changes in suicidal ideation, functional brain connectivity, and neurophysiological circuit activity are associated with improvement in suicidal symptoms. Participants will undergo clinical and behavioural assessments, MRI, EEG, and digital monitoring before and after treatment, with post-treatment assessments taking place approximately 2 to 8 weeks later. Treatment is not assigned by the study but determined by the clinical care team, and the study includes two observational groups: ketamine/esketamine and ECT.

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Target Enrollment
60 participants
Study Type
observational
Design
Non-randomized

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Topic research: Suicidality

Detailed Description

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.

Study Arms & Interventions

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.

Participants

Ages
18 – 65
Sexes
Male & Female

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

Study Protocol, Arms & Participants

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Study Details

  • Status
    Not yet recruiting
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment60 participants
  • Timeline
    Start: 2026-07-01
    End: 2030-08-31
  • Topic
    Suicidality

Study Team

Sponsors & Collaborators

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