ClinicalTrials.gg
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

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 11 months later.

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Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 193 studies in Schizophrenia with a site in Canada — 29 open to participants now, 37 under way, 1 of them phase 3. Schizophrenia · Canada.

Planned enrollment
19th of 30
90 · median 109
Started
2019
with 11 others
Observational
30 of 193
8 open now
Primary completion
2026-10
later than 15 of 36 live
Registered
144th of 193
by date
Lead sponsor
8 of 193
The Royal Ottawa Mental Health Centre

Among the 193 studies in Schizophrenia with a site in Canada, this one is the 19th largest by planned enrollment of the 30 observational ones that give a count, is one of 12 that started in 2019, is one of 30 observational ones, reaches primary completion later than 15 of the 36 other live ones, and was the 144th registered.

Schizophrenia

3,567 studies on the registry are indexed under Schizophrenia; 493 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

29 of the 193 studies in Schizophrenia with a site in Canada are open now. Recruiting first, the newest first:

23 more — sign in →

All 29 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Schizophrenia / Schizoaffective Disorder
  • Depression / Major Depressive Disorder
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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) (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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)

07

Study locations

1 of 1 sites recruiting
  • Royal Ottawa Mental Health Center
    Ottawa, Ontario K1Z 7K4, Canada
    Recruiting
08

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: Statistical analysis plan, 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).

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2019 (actual). Primary completion is estimated for Oct 2026, 81 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2019
First posted
Nov 12, 2019
StartActual
Dec 12, 2019
Primary completionEst.
Oct 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Mar 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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