Brain Imaging of Cognition Inn Schizophrenia and Depression

Depression / Major Depressive Disorder Clinical Trial

Official title:

Brain Imaging of Cognition Inn Schizophrenia and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159662
• Other study ID #: 2018037
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: The Royal Ottawa Mental Health Centre
• Contact: Synthia Guimond, PhD
• Phone: 6137226521
• Email: Synthia.Guimond[@]theroyal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression / Major Depressive Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Psychotic Disorders
• Schizophrenia
• Schizophrenia / Schizoaffective Disorder

Locations

Country	Name	City	State
Canada	Royal Ottawa Mental Health Center	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Ottawa Mental Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	Change in verbal memory performance from baseline - Hopkins Verbal Learning Test-Revised (HVLT-R)	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.	baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
Primary	Change in emotion regulation performance from baseline - Mayer-Salovey-Caruso Emotional Intelligence Test (MSECIT)	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).	baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
Secondary	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)
Secondary	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)