Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02811198
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 80
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	Phase
Major Depressive Disorder; Suicide; Suicidal Ideation	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers, task performance [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sakina Rizvi	Toronto	Ontario	Canada	M5B1M8

Sponsors and Collaborators

• Unity Health Toronto

Investigators

• Principal Investigator: Sakina Rizvi, PhD, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sakina Rizvi, Scientist, Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02811198
• Other Study ID Numbers: SBIO-01
• First Posted: Jun 23, 2016
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major; Suicide; Suicidal Ideation

Study Results

No Results Posted as of Jul 28, 2022