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Brain Imaging of Cognition Inn Schizophrenia and Depression

T

The Royal Ottawa Mental Health Centre

Status

Enrolling

Conditions

Depression / Major Depressive Disorder
Schizophrenia / Schizoaffective Disorder

Treatments

Behavioral: Cognitive Intervention
Behavioral: Active Control Intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04159662
2018037

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

Individuals with Schizophrenia or Schzioaffective Disorders
Description:
Clinical group
Individuals with Major Depressive Disorder
Description:
Clinical group
Healthy Individuals
Description:
Control group

Trial contacts and locations

1

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Central trial contact

Synthia Guimond, PhD

Data sourced from clinicaltrials.gov

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