Recruiting

Cognition in Schizophrenia

Sponsor:

The Royal Ottawa Mental Health Centre

Code:

NCT04159662

Conditions

Schizophrenia / Schizoaffective Disorder

Depression / Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04159662

Start date

Dec 12, 2019

Status verified date

Mar, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals with Schizophrenia or Schzioaffective Disorders

Clinical group

Individuals with Major Depressive Disorder

Clinical group

Healthy Individuals

Control group

Primary outcome measure

  • Measuring brain activity using resting-state and task-based functional MRI [ Time Frame: Final Visit (Visit 3) ]

Central Contacts and Locations

Central contacts

Synthia Guimond, PhD

6137226521Synthia.Guimond@theroyal.ca

Locations

Royal Ottawa Mental Health Center

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Synthia Guimond, PhD

6137226521Synthia.Guimond@theroyal.ca

More Information

Sponsor

The Royal Ottawa Mental Health Centre

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Royal Ottawa Mental Health Centre on 2026-03-23.