Tracking Outcomes in Psychosis

NCT02882204 | Unknown

• 1 other identifier: 10014067
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in Thought Language Index Score between baseline and 6 months

  Predicting the change in TLI score based on baseline anatomical abnormalities identified through MRI

  6 Months

• Time to remission of positive symptoms of psychosis

  The time between baseline and remission of positive symptoms based on PANSS-8

  30 months

• Time to remission of negative symptoms of psychosis

  The amount of time between baseline and remission of negative symptoms based on PANSS-8

  30 months

• Emergence of treatment resistance using operational criteria

  30 months

Secondary Outcomes (3)

• Change in Thought Language Index score between baseline and longitudinal follow up-dates (12 months, 18 months, 24 months and 30 months)

  1-2.5 years

• Change in overall symptoms over time

  30 months

• Changes in myelin content

  30 months (follow up period for first episode patients)

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes two groups of individuals: 1. First Episode psychotic patients: This group will contain 84 new patients enrolled in the Prevention and early Intervention Program for Psychosis. 2. Chronic Patients: This group will contain 42 patients who have been enrolled in the Prevention and Early Intervention Program for Psychosis for \>3 years. 3. Healthy Controls: This group will contain 42 healthy controls not being treated for a major mental illness defined using DSM-V criteria.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

Robarts Research

London, Ontario, N6A 5B7, Canada

RECRUITING

Related Publications (5)

• Harrow M, Marengo JT. Schizophrenic thought disorder at followup: its persistence and prognostic significance. Schizophr Bull. 1986;12(3):373-93. doi: 10.1093/schbul/12.3.373.

  PMID: 3764358 BACKGROUND

• Palaniyappan L, Mahmood J, Balain V, Mougin O, Gowland PA, Liddle PF. Structural correlates of formal thought disorder in schizophrenia: An ultra-high field multivariate morphometry study. Schizophr Res. 2015 Oct;168(1-2):305-12. doi: 10.1016/j.schres.2015.07.022. Epub 2015 Jul 29.

  PMID: 26232240 BACKGROUND

• Liddle PF, Ngan ET, Caissie SL, Anderson CM, Bates AT, Quested DJ, White R, Weg R. Thought and Language Index: an instrument for assessing thought and language in schizophrenia. Br J Psychiatry. 2002 Oct;181:326-30. doi: 10.1192/bjp.181.4.326.

  PMID: 12356660 BACKGROUND

• Aoyama N, Theberge J, Drost DJ, Manchanda R, Northcott S, Neufeld RW, Menon RS, Rajakumar N, Pavlosky WF, Densmore M, Schaefer B, Williamson PC. Grey matter and social functioning correlates of glutamatergic metabolite loss in schizophrenia. Br J Psychiatry. 2011 Jun;198(6):448-56. doi: 10.1192/bjp.bp.110.079608.

  PMID: 21628707 BACKGROUND

• American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5®) (2013).

  BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Lena Palaniyappan, MD, PhD

CONTACT

519.685.8054; lena.palaniyappan.@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 21, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)