Recruiting

Observational Study

Sponsor:

Douglas Mental Health University Institute

Code:

NCT06978894

Conditions

Psychosis

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Psychotic disorders, including schizophrenia and affective psychosis, are severe mental health conditions marked by recurrent episodes that contribute to long-term disability. Relapses, characterized by the re-emergence of psychotic symptoms after remission, are a critical factor in the progression of these disorders, increasing risks such as suicide, cognitive impairment, and unemployment. This study aims to develop a novel, speech-based digital model to predict relapses in individuals with psychosis. Building on previous research into language abnormalities in schizophrenia, the study will employ a longitudinal design across Early Psychosis Intervention (EPI) clinics in Ontario and Quebec to advance relapse prediction

Conditions

Psychosis

Study ID

NCT06978894

Start date

May 27, 2024

Status verified date

Nov, 2024

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age must be 16 years and older
  • Diagnosis must meet DSM-5 criteria for psychotic disorders, including schizophrenia, schizoaffective disorder, or related conditions
  • Fluency in English or French
  • Must be currently receiving treatment through an EPI program

Exclusion Criteria:

  • Severe comorbid speech or language disorders (e.g., aphasia)
  • Primary diagnosis of non-psychotic disorders
  • Inability to provide consent or complete assessments

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Early Psychosis Patients

This study will participants recruited from three Early Psychosis Intervention (EPI) programs across Ontario and Quebec.

This group will consist of approximately 250 patients experiencing or having experienced psychosis, enrolled in the EPI programs.

Primary outcome measure

  • Likelihood of relapse estimated using Speech-NLP Metrics [ Time Frame: Monthly, up to 24 months ]
  • Generalization of Speech-Based Relapse Prediction Models Across Languages and Genders [ Time Frame: Monthly, up to 24 months ]

Central Contacts and Locations

Central contacts

Lena Palaniyappan, MD, PHD

5147616131lena.palaniyappan@mcgill.ca

Locations

Robarts Research Institute

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Michael MacKinley, PHD

519.931.5777michael.mackinley@lhsc.on.ca

Douglas Mental Health University Institute

Recruiting

Montreal, Quebec, Canada, H4H 1A8

Contacts

Lena Palaniyappan, MD, PHD

5147616131lena.palaniyappan@mcgill.ca

Vitam

Recruiting

Quebec, Canada, G1J 2G1

Contacts

Amélie M Achim, Phd

418 663-5741amelie.achim@fmed.ulaval.ca

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

May 18, 2025

Last verified

Nov, 2024

Keywords

  • psychosis
  • natural language processing
  • relapse
  • speech
  • relapse prediction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2025-05-18.