Schizophrenia / Schizoaffective DisorderNCT04159662
Brain Imaging of Cognition Inn Schizophrenia and Depression
An observational study of Schizophrenia / Schizoaffective Disorder and Depression / Major Depressive Disorder, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia / Schizoaffective Disorder, Depression / Major Depressive Disorder
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2019to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals with an official diagnosis of: Schizophrenia, Schzioaffective or Major Depressive Disorders.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Ottawa Mental Health Center
Ottawa, Ontario, K1Z 7K4
Synthia Guimond, PhD, 6137226521 ext. 6586, Synthia.Guimond@theroyal.ca
About this study
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.
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Schizophrenia or Schzioaffective Disorders | Clinical group | |
| Individuals with Major Depressive Disorder | Clinical group | |
| Healthy Individuals | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring brain activity using resting-state and task-based functional MRI
To better understand the mechanisms underlying cognitive problems in our populations of interest
Measured: Final Visit (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start12 Dec 2019
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia / Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Synthia Guimond, The Royal Ottawa Mental Health Centre
- Investigators
- Synthia Guimond, PhD, Principal investigator, Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159662
- Sponsor's protocol ID
- 2018037
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging of Cognition Inn Schizophrenia and Depression
- ClinicalTrials.gov ID
- NCT04159662
- Acronym / sponsor ID
- 2018037
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with Schizophrenia or Schzioaffective Disorders | – | –Clinical group |
| Individuals with Major Depressive Disorder | – | –Clinical group |
| Healthy Individuals | – | –Control group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with an official diagnosis of: Schizophrenia, Schzioaffective or Major Depressive Disorders.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring brain activity using resting-state and task-based functional MRI
Time frame: Final Visit (Visit 3)
To better understand the mechanisms underlying cognitive problems in our populations of interest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Synthia Guimond, PhD principal investigator
Royal Ottawa Mental Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia / Schizoaffective Disorder and Depression / Major Depressive Disorder, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Synthia Guimond, PhD (6137226521 ext. 6586, Synthia.Guimond@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring brain activity using resting-state and task-based functional MRI (time frame: Final Visit (Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.