Recruiting

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT02882204

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

Brief summary:

The investigators propose to study the brain processes that result in thought and language disorder and influence outcomes seen in patients with schizophrenia using a combination of brain scans and clinical assessments. The project will assess patients at various stages of psychosis (Clinical high risk, first episode and chronic stage >3 years of illness) referred to the Prevention and Early Intervention in Psychosis Programme using Magnetic Resonance Imaging (MRI scans). To track the outcome of this illness, investigators will follow-up patients over 3 years and collect MRI scans over four sessions for each first episode patient, and two sessions for clinical high risk patients, chronic patients, and healthy controls. Participants will also complete a clinical assessment examining symptoms and functioning as per the current clinical practice within the PEPP program at each scanning session.

Conditions

Schizophrenia

Study ID

NCT02882204

Start date

Mar 1, 2016

Status verified date

Sep, 2019

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 16-45 years old
  • Outpatient of the Prevention and Early Intervention Program for Psychosis

Exclusion Criteria:

  • Drug or alcohol dependence in past year
  • History of head injury (with associated unconsciousness for any period)
  • Mental retardation or suffering from medical conditions such as untreated hypertension, diabetes, hepatic/renal insufficiency, neurological illnesses
  • Otherwise unable to provide informed consent

Study Design

Enrollment

168 participants

Anticipated

Interventions and Outcome Measures

Arms

First Episode Patients

First episode patients new to the PEPP program.

Chronic Patients

Existing patients who have been enrolled in the PEPP program for >3 years

Healthy Controls

Healthy controls who are not currently in treatment for any major mental illness defined using DSM-V criteria.

Cliniucal High Risk patients

Patients who are accessing PEPP services during the prodromal phase of psychotic illness.

Primary outcome measure

  • Change in Thought Language Index Score between baseline and 6 months [ Time Frame: 6 Months ]
  • Time to remission of positive symptoms of psychosis [ Time Frame: 30 months ]
  • Time to remission of negative symptoms of psychosis [ Time Frame: 30 months ]
  • Emergence of treatment resistance using operational criteria [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Lena Palaniyappan, MD, PhD

519.685.8054lena.palaniyappan.@lhsc.on.ca

Locations

Robarts Research

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Lena Palaniyappan, MBBS, PhD

519-685-8054lena.palaniyappan@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Feb 21, 2020

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2020-02-21.