Brain Imaging of Cognition Inn Schizophrenia and Depression

NCT04159662 | Recruiting

• 1 other identifier: 2018037
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. In this study, brain imaging is used to investigate the brain mechanisms underlying these cognitive deficits in these populations.

Conditions

Schizophrenia / Schizoaffective Disorder; Depression / Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Measuring brain activity using resting-state and task-based functional MRI

  To better understand the mechanisms underlying cognitive problems in our populations of interest

  Final Visit (Visit 3)

Study Arms (3)

Individuals with Schizophrenia or Schzioaffective Disorders

Clinical group

Individuals with Major Depressive Disorder

Clinical group

Healthy Individuals

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with an official diagnosis of: Schizophrenia, Schzioaffective or Major Depressive Disorders.

You may qualify if:

• age 18-60 years
• current Intelligence Quotient (IQ) \> 70 as measured by the Wechsler Abbreviated Scale of Intelligence (WASI)
• the ability to read and speak fluent English
• a diagnosis of schizophrenia, schizoaffective or major depression disorder
• stable medication for more than one month

You may not qualify if:

• significant neurological or other medical disorders that may produce cognitive impairment
• a recent history of substance abuse or dependence (within the past 3 months)
• any magnetic resonance imaging (MRI) contraindications (e.g. metallic head implant, history of seizure, pacemaker)
• decisional incapacity requiring a guardian
• taking medications that are rated as Anticholinergic Burden (ACB) Score 3 (severe) or taking benzodiazepines on a daily basis
• Finally, participants could not be severely symptomatic at the time of study enrolment to ensure that they could understand and complete all study assessments. This criterion was defined as a score ≤34 on the Montgomery-Åsberg Depression Rating Scale (MADRS; Montgomery \& Åsberg, 1979) for the MDD group and a score ≤95 on the Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987) for the SZ group.

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

Royal Ottawa Mental Health Center

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Study Officials

• Synthia Guimond, PhD

  Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Synthia Guimond, PhD

CONTACT

6137226521; Synthia.Guimond@theroyal.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 12, 2019
• Study Start: December 12, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: De-identified data will become available upon completion of the study and once results have been published in an academic journal (anticipated time frame: the year of 2024).

Locations

CA (1)