Clinical trial NCT04159662: Brain Imaging of Cognition Inn Schizophrenia and Depression
Official title: Brain Imaging of Cognition Inn Schizophrenia and Depression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia / Schizoaffective Disorder
Depression / Major Depressive Disorder
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with an official diagnosis of: Schizophrenia, Schzioaffective or Major Depressive Disorders.

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, we are using brain imaging to investigate the brain mechanisms underlying these cognitive deficits in these populations.

Detailed description: This study uses Functional Magnetic Resonance Imaging (fMRI) to help us better understand the cognitive problems that people who have schizophrenia, schizoaffective disorder, or depression experience. Cognitive problems can encompass a variety of different domains such as with attention, thinking, memory, emotion, and emotional regulation.

The study will involve three visits at The Royal's Institute of Mental Health Research. Each visit will last about 2.5 hours long.

Visits 1 and 2: We ask participants to fill out several questionnaires on a computer. We also ask participants to answer some questions about their current and past mental health. Participants will also perform some tasks involving general thinking skills.

Visit 3: This is the scan visit where we use fMRI, which is a technique that allows us to take a 3D picture of the brain using magnetic fields. It also allows us to estimate how active different regions of the brain are. During the fMRI, participants will lay down in a narrow tube in the fMRI scanner and hold still. Throughout the experiment, participant will perform three short tasks in the scanner, where they will see words and pictures and press a button to answer some questions.

Eligibility criteria: Inclusion Criteria:

* age 18-65 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

Primary outcomes:
measure: Change in verbal memory performance from baseline - Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
measure: Change in emotion regulation performance from baseline - Mayer-Salovey-Caruso Emotional Intelligence Test (MSECIT)
timeFrame: baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
Secondary outcomes:
measure: Change in composite scores on cognitive assessments from baseline
timeFrame: baseline and post treatment (7 weeks)
measure: Change in brain activity from baseline
timeFrame: baseline and post treatment (8 weeks)
Other outcomes:
measure: Change in composite scores on social functioning from baseline
timeFrame: baseline and post treatment (9 weeks)
measure: Change in symptom severity from baseline - Positive and Negative Syndrome Scale (PANSS)
timeFrame: baseline and post treatment (9 weeks)
measure: Change in perceived cognitive impairments from baseline - Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B)
timeFrame: baseline and post treatment (9 weeks)
Locations:
city: Ottawa
country: Canada
facility: Royal Ottawa Mental Health Center
state: Ontario
Study officials:
affiliation: Royal Ottawa Mental Health Centre
name: Synthia Guimond, PhD
role: PRINCIPAL_INVESTIGATOR
References: