- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02811198
Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The issue of suicide has continued to puzzle researchers in the field of psychiatry. Edwin Shneidman, a prominent researcher on suicide emphasized "the most evident fact about suicidology and suicidal events is that they are multidimensional…containing concomitant biological, sociological, and psychological (interpersonal and intrapsychic)…elements". Yet, no study to date has attempted to integrate these dimensions when evaluating suicide risk. Considering the presence of a psychiatric illness is a primary predictor of suicide, it is important to develop a unified understanding of risk factors that integrate current clinical and neurobiological findings in this population.
Our aim is to: (1) identify an integrated biomarker model to predict risk of suicide attempt in patients with Major Depressive Disorder (MDD) with and without a history of suicide attempt, using neuroimaging, neurocognitive testing and behavioural tasks, and (2) test the stability of this model using a prospective 1 year design.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B1M8
- Sakina Rizvi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- DSM-5 criteria for Major Depressive Episode within a MDD, confirmed through MINI diagnosis104
- Ages between 18 and 70 years
- Hamilton Depression Rating Scale - 17 item (HAMD-17) >= 14
- Capable of giving informed consent
- Groups 1 and 2 participants only: HAMD-17 item 3 (suicide) >= 2
- Group 2 participants only: positive history of a suicide attempt within the last six months
- Group 3 participants only: positive history of a lifetime suicide attempt
Exclusion Criteria:
- Pregnancy/lactation
- Medical condition requiring immediate investigation or treatment
- Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
- Lifetime history of psychosis, Bipolar I or Bipolar II; other Axis I comorbidities are allowable
- Individuals who are taking a daily sedative hypnotic, atypical antipsychotic or stimulant must be on a stable dose for at least 4 weeks prior to the neuroimaging scan. The dose must not be taken after 10:00pm the evening prior to the scan. Those receiving a benzodiazepine or an atypical antipsychotic on an "as needed" basis (taken, but not every day) will be washed out of their benzodiazepine/atypical antipsychotic for two weeks prior to neuroimaging. Those receive stimulants on an "as needed" basis will be washed out for 1-3 days prior to neuroimaging, depending on the stimulant half-life.
- Participation in experimental treatment trials for the study duration.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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MDD with SI and No Attempt
Subjects will have MDD with current MDE, current suicidal ideation and no lifetime suicide attempts
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MDD with SI and Recent Attempt
Subjects with have MDD with current MDE, current suicidal ideation and a suicide attempt within the past 6 months
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MDD with no SI and Lifetime Attempt
Subjects with MDD and current MDE but no current suicidal ideation and a lifetime suicide attempt.
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Healthy Controls
Subjects will have no personal or family psychiatric history and no suicide attempts.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Biomarkers for Suicide Risk
Time Frame: 12 months
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Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers,
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sakina Rizvi, PhD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBIO-01
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