Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811198
Recruitment Status : Unknown
Verified October 2017 by Sakina Rizvi, St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sakina Rizvi, St. Michael's Hospital, Toronto

Brief Summary:
The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring the "hedonic spectrum" (pain and reward responsivity), attention and its associated brain structures using brain scans (fMRI and DTI), as well as the stability of markers over time.

Condition or disease Intervention/treatment
Major Depressive Disorder Suicide Suicidal Ideation Other: No intervention

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Group/Cohort Intervention/treatment
MDD with SI and No Attempt
Subjects will have MDD with current MDE, current suicidal ideation and no lifetime suicide attempts
Other: No intervention
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
Other: No intervention
MDD with no SI and Lifetime Attempt
Subjects with MDD and current MDE but no current suicidal ideation and a lifetime suicide attempt.
Other: No intervention
Healthy Controls
Subjects will have no personal or family psychiatric history and no suicide attempts.
Other: No intervention



Primary Outcome Measures :
  1. Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers, task performance [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Blood samples will be collected for genetic and proteomic analysis. Saliva samples will be collected to measure cortisol levels.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will recruited from Mental Health Clinics at St. Michael's Hospital from Mood Disorders Clinics and self-referrals from advertisements in Mental Health Department.
Criteria

Inclusion Criteria:

  1. DSM-5 criteria for Major Depressive Episode within a MDD, confirmed through MINI diagnosis104
  2. Ages between 18 and 70 years
  3. Hamilton Depression Rating Scale - 17 item (HAMD-17) > 14
  4. Capable of giving informed consent
  5. Groups 1 and 2 participants only: HAMD-17 item 3 (suicide) > 2
  6. Group 2 participants only: positive history of a suicide attempt within the last six months
  7. Group 3 participants only: positive history of a lifetime suicide attempt

Exclusion Criteria:

  1. Pregnancy/lactation
  2. Medical condition requiring immediate investigation or treatment
  3. Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
  4. Lifetime history of psychosis, Bipolar I or Bipolar II; other Axis I comorbidities are allowable
  5. No current Axis II diagnosis, confirmed by International Personality Disorder Examination (IPDE)
  6. Participation in experimental treatment trials for the study duration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811198


Contacts
Layout table for location contacts
Contact: Nicole Edgar, HBSc 416-864-6099 edgarn@smh.ca

Locations
Layout table for location information
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1M8
Contact: Nicole Edgar, HBSc    416-864-6099    edgarn@smh.ca   
Principal Investigator: Sakina Rizvi, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Sakina Rizvi, PhD St. Michael's Hospital, Toronto
Layout table for additonal information
Responsible Party: Sakina Rizvi, Scientist, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02811198    
Other Study ID Numbers: SBIO-01
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Suicide
Suicidal Ideation
Mood Disorders
Mental Disorders
Behavioral Symptoms
Self-Injurious Behavior