Brain Imaging of Cognition Inn Schizophrenia and Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia / Schizoaffective Disorder; Depression / Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive Intervention; Behavioral: Active Control Intervention

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 Type: Observational
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Synthia Guimond, PhD; Phone Number: 6586 6137226521; Email: Synthia.Guimond@theroyal.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 7K4
      • Recruiting
      • Royal Ottawa Mental Health Center
      • Contact: Synthia Guimond, PhD; Phone Number: 6586 6137226521; Email: Synthia.Guimond@theroyal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Individuals with Schizophrenia or Schzioaffective Disorders; Clinical group
Individuals with Major Depressive Disorder; Clinical group
Healthy Individuals; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite scores on cognitive assessments from baseline	Assessed with a battery of standardized tests examining cognitive capacity. These tests measure various cognitive domains such as attention, memory, executive function, speed of processing and emotion recognition.	baseline and post treatment (7 weeks)
Change in brain activity from baseline	Brain activity as measured using resting-state and task-based functional magnetic resonance imaging (fMRI).	baseline and post treatment (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite scores on social functioning from baseline	Assessed with a battery of standardized tests examining social functioning. These tests measure an individual's level of social and occupational functioning as well as performance on everyday functional tasks (e.g., making phone calls, counting change, etc.).	baseline and post treatment (9 weeks)
Change in symptom severity from baseline - Positive and Negative Syndrome Scale (PANSS)	The Positive and Negative Syndrome Scale (PANSS) is a 30-item medical scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with a larger score indicating greater severity of symptoms.	baseline and post treatment (9 weeks)
Change in perceived cognitive impairments from baseline - Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B)	The Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B) is a self-rated 14-item scale that assesses the subjective level of cognitive abilities over the past week, ranging from "never" to "very often". The total score of SSTICS ranges from 0 to 84, with a greater score indicating greater perceived cognitive impairments.	baseline and post treatment (9 weeks)

Collaborators and Investigators

• Sponsor: The Royal Ottawa Mental Health Centre
• Investigators: Principal Investigator: Synthia Guimond, PhD, Royal Ottawa Mental Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Schizophrenia; Psychotic Disorders; Depression; Depressive Disorder, Major
• Other Study ID Numbers: 2018037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No