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RecruitingNCT04159662Updated Mar 23, 2026

Brain Imaging of Cognition Inn Schizophrenia and Depression

An observational study in Schizophrenia / Schizoaffective Disorder and Depression / Major Depressive Disorder, sponsored by The Royal Ottawa Mental Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by The Royal Ottawa Mental Health Centre · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the detailed description

This study uses Functional Magnetic Resonance Imaging (fMRI) which is a technique that takes a 3D picture of the brain using magnetic fields. It allows researchers to estimate how active different regions of the brain are. The aim of this study is to use fMRI to better understand the cognitive problems that individuals living with schizophrenia, schizoaffective disorder, or depression experience.

The study will involve three visits at The Royal's Institute of Mental Health Research in Ottawa, Canada. Each visit will last about 2.5 hours long.

Visits 1 and 2: Participants are asked to fill out several questionnaires on a computer. Participants are also asked to answer some questions about their current and past mental health as well as perform some tasks involving general thinking skills.

Visit 3: Participants will complete a brain scan using fMRI. Throughout the experiment, participants will perform three short tasks in the fMRI scanner. Participants will use buttons to answer some questions in response to some words and pictures.

02

Conditions studied

  • Schizophrenia / Schizoaffective Disorder
  • Depression / Major Depressive Disorder
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Individuals with Schizophrenia or Schzioaffective Disorders

    Clinical group

  • Individuals with Major Depressive Disorder

    Clinical group

  • Healthy Individuals

    Control group

05

What researchers measure

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

    Time frame: Final Visit (Visit 3)

06

Study locations

1 of 1 sites recruiting
  • Royal Ottawa Mental Health Center
    Ottawa, Ontario K1Z 7K4, Canada
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.

Supporting information: Sap, Analytic code

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04159662
Lead sponsor
The Royal Ottawa Mental Health Centre
Responsible party
Synthia Guimond (Scientist, The Royal Ottawa Mental Health Centre) — Principal investigator
First posted
Nov 12, 2019
Start date
Dec 12, 2019
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Mar 23, 2026

Study contacts

Synthia Guimond, PhD
Contact
Synthia.Guimond@theroyal.ca
6137226521 ext. 6586
Synthia Guimond, PhD
principal investigator · Royal Ottawa Mental Health Centre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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