Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681807
• Other study ID #: 2019033
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: The Royal Ottawa Mental Health Centre
• Contact: Synthia Guimond
• Phone: 6137226521
• Email: Synthia.Guimond[@]theroyal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.

Description:

All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or an active control training program on iPad that includes commercial games and control emotional attention bias training.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• Between (or equal to) 15-25 years of age
• Ability to read/speak fluent English
• Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).

Exclusion Criteria:

• Diagnosis of mental health disorder
• Significant neurological or medical disorders that may produce cognitive impairment
• Current epilepsy or previous history of seizures
• Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
• Recent history of substance abuse or dependence (within past 3 months)
• MRI contraindication (e.g. metallic head implant, history of seizure, pacemaker, pregnancy, etc.)
• Current IQ < 70 as measured by the Wechsler Abbreviated Scale of Intelligence Scale (WASI)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Emotion Recognition Training
Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of an emotion recognition training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .
• Active Control Training
Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of a control training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .

Locations

Country	Name	City	State
Canada	The Royal Ottawa Mental Health Centre	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
Primary	Change in emotion recognition performance from baseline - PENN Emotion Recognition Test	Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions	baseline and post treatment (1 month)
Primary	Change in brain activity during emotion recognition tasks from baseline	Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).	baseline and post treatment (1 month)