NCT06978803 HYEEG Discourse in Psychosis: A Neurobehavioural Study
| NCT ID | NCT06978803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Douglas Mental Health University Institute |
| Condition | Psychosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2025-10-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-01-16 with a primary completion date of 2025-10-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multimodal study explores the mechanisms underlying social dysfunction in individuals with schizophrenia. It focuses on the relationship between disorganized communication and social interaction, aiming to identify measurable markers of disorganized communication and link them to clinical symptoms and social functioning. Key Research Questions: How do neural and behavioural synchrony contribute to social impairments in schizophrenia? What roles do interbrain synchrony, motor imitation, reaction time, and verbal coherence play in disorganized communication? Participants will: 1. Engage in structured and semi-structured real-time social interactions while undergoing dual-brain electroencephalogram (EEG) hyperscanning to measure neural and behavioural activity. 2. Perform nonverbal tasks such as motor imitation and reaction time assessments to investigate coordination and behavioural synchrony patterns. 3. Participate in a clinical interview that evaluates verbal production, thought coherence, and speech organization. By combining these assessments, the study aims to advance our understanding of how social and communication impairments manifest in schizophrenia. The findings will contribute to developing improved diagnostic tools and targeted interventions, ultimately supporting patients in achieving better social functioning and quality of life.
Eligibility Criteria
Inclusion Criteria: 1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria (Zipursky et al., 2020). 4. Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication. Exclusion Criteria: 1. Participants should not have a primary diagnosis of Alcohol or Drug abuse or addiction (however, co-morbid substance abuse with a primary diagnosis of psychotic disorder is not an exclusion criterion). 2. Participants should not have a severe medical disorder that would explain psychotic symptoms. 3. Participants should not have a past or current history of a primary neurological disorder that can affect speech output 4. Participants with IQ below 70 or a concurrent pervasive developmental disorder (e.g., autism) will also be excluded.
Contact & Investigator
Lena Palaniyappan, MD, PhD
PRINCIPAL INVESTIGATOR
Douglas Mental Health University Institute
Frequently Asked Questions
Who can join the NCT06978803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06978803 currently recruiting?
Yes, NCT06978803 is actively recruiting participants. Contact the research team at emmanuel.olarewaju@mail.mcgill.ca for enrollment information.
Where is the NCT06978803 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06978803 clinical trial?
NCT06978803 is sponsored by Douglas Mental Health University Institute. The principal investigator is Lena Palaniyappan, MD, PhD at Douglas Mental Health University Institute. The trial plans to enroll 110 participants.