Brain Imaging of Cognition Inn Schizophrenia and Depression

Recruiting

• Conditions: Depression / Major Depressive Disorder; Schizophrenia / Schizoaffective Disorder

• Registration Number: NCT04159662
• Lead Sponsor: The Royal Ottawa Mental Health Centre

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.

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Study Start: 2019-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in verbal memory performance from baseline - Hopkins Verbal Learning Test-Revised (HVLT-R)	baseline, mid-treatment (3 weeks) and post treatment (7 weeks)	The Hopkins Verbal Learning Test - Revisited (HVLT-R) for verbal memory is a 12-item test to measure a person's ability to encode, combine, store and recover verbal information in memory.
Change in emotion regulation performance from baseline - Mayer-Salovey-Caruso Emotional Intelligence Test (MSECIT)	baseline, mid-treatment (3 weeks) and post treatment (7 weeks)	The Mayer-Salovey- Caruso Emotional Intelligence Test (MSCEIT) is a 141-item ability-based test designed to measure the four branches of emotional intelligence model of Mayer and Salovey (including emotion regulation).

Secondary Outcome Measures

Name	Time	Method
Change in composite scores on cognitive assessments from baseline	baseline and post treatment (7 weeks)	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.
Change in brain activity from baseline	baseline and post treatment (8 weeks)	Brain activity as measured using resting-state and task-based functional magnetic resonance imaging (fMRI).

Trial Locations

Locations (1)

Royal Ottawa Mental Health Center; 🇨🇦 Ottawa, Ontario, Canada