NCT06978465Not yet recruiting
DIALOG: Understanding Disorganisation: A Language-focused Global Initiative in Psychosis
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Disorganized speech, language and communication, also called 'formal thought disorder,' is a key part of severe mental illnesses like psychosis and mood disorders. When someone's communication is disorganized, it makes social interactions difficult, increases stigma and affect educational and employment opportunities. However, we do not know much about why this happens. This project, called DIALOG, aims to understand the brain's role in disorganization by studying everyday language use instead of traditional clinical ratings. The study will look at how our brain creates predictions during interactions and how these processes break down in psychosis. This international project also includes experts with personal experience of mental illness. The study will look at speech, thinking patterns, symptoms, and brain waves. The goal of the study is to see if brain waves are disrupted in psychosis, especially in language-related problems. Speech tasks, like describing pictures, talking about a significant event, and telling a story are administered. These tasks will be audio-recorded for analysis. Non-invasive brain imaging technologies such as Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) are utilized. MRI creates images of the brain's structure, while MEG records magnetic activity from neurons, shown as brain waves. The MRI machine uses a large magnet to create images, and MEG captures small magnetic field changes from brain activity. Participants will also undergo clinical and neurocognitive assessments. The study will combine Large Language Models (LLM) applied to speech recordings with large scale participant data from neuroimaging tools (MRI/MEG). The goal of DIALOG is to pioneer a computationally informed, molecular-to systems-level account of disorganisation, identifying the precise mechanisms that can be targeted with novel treatments. This project aims to gather speech and neuroimaging data from Montreal \[100 healthy volunteers and 50 patients with psychosis\], Groningen \[17 synaptic density PET scans\], Cardiff \[600 participants\] and Marburg \[1600 participants\] with schizophrenia, schizoaffective disorder or mood disorders and user acceptability data at Pavia and Melbourne.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 11 May 2025
- Start date
- May 2025
- Primary completion date
- Apr 2030
- Lead sponsor
- Douglas Mental Health University Institute
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT06978465
What you commit to
- Study type: Observational
- Planned participants: 150
- From May 2025 to the primary completion date, Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnancy; substance-induced psychosis with no SMD; neurological speech or auditory impairment, contraindication for MRI; Not able to give informed consent (if this is in doubt at the time of referral, we will formally test it). Not be able to speak French or English for clinical interactions; participants who are not proficient will be excluded.
Who the study is looking for
- \- English or French speaking participants, male or female; age 18-65 years. Patients who have been previously diagnosed by their treating physician based on the Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM 5) criteria for schizophrenia or schizoaffective disorder. Ethnically and socioeconomically diverse individuals from urban catchments. Women are under-represented in psychosis studies but across sexes disorganisation is equally severe. We aim for \>40% women in our samples via broader inclusion criteria not limited to schizophrenia.
- Healthy Controls group-matched with the patients for age (within 2 years), and sex matched to patient sample; and have no personal or first-degree family history of Severe Mental Disorders (SMD).
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Douglas Mental Health University Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.