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Tracking Outcomes in Psychosis (TOPSY)

20. februar 2020 opdateret af: Lawson Health Research Institute
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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

OBJECTIVES: The objective of this study is to investigate the pathophysiology of Formal Thought Disorder and variable outcomes in the early stages of schizophrenia. In particular, investigators aim to test the hypothesis that 1. Anatomical abnormalities involving the grey matter of the Anterior Insula and Medial Prefrontal Cortex in first episode schizophrenia predicts FTD that persists by 6 months of illness 2. An excess of glutamine/glutamate, or reduction in glutathione, in Medial Prefrontal Cortex at index episode will be associated with persistent FTD 3.Aberrant connectivity between Anterior Insula and Medial Prefrontal Cortex will specifically predict the severity of persistent FTD irrespective of the stage of illness; the change in this connectivity will track the variable 3-year outcome among patients with first episode of psychosis.

METHODS: This study will employ a cross-sectional design recruiting n=126 participants from the Prevention & Early Intervention Program for Psychoses (PEPP). Four groups of participants will be assessed: patients at a later stage of schizophrenia (chronic illness group) (n=42), newly referred first episode group of PEPP patients (n=84), Clinical High Risk patients (n=60) and healthy Controls (n=45). Measurements: Patients will be diagnosed using the criteria for schizophrenia according to DSM-V(34). Demographic variables such as age, gender and parental socioeconomic status will be recorded to adjust for potential confounding effects. Patients will undergo baseline assessments to assess seven features of FTD (poverty of speech, weakening of goal, perseveration, looseness, peculiar word usage, peculiar sentence usage and peculiar logic) in line with the validated procedure for administering Thought Language Index [TLI](17). First episode patients will undergo four 7T MRI scanning sessions over the course of 2.5 years (baseline, 6 months, 18 months, 30 months)lasting for 60 minutes each, as described in our previous work (15). During this time, researchers will perform MR spectroscopy (MPFC voxel (31)), T1 weighted structural scan and eyes-closed, task-free, 6 minutes resting-state functional MRI. 6 months after the onset of first episode, the clinical assessment will be repeated using TLI. Patients with persistent FTD will be identified (from previous studies, 40% of patients are expected to have persistent FTD (9)) and separated from patients who have no FTD at 6-months time point. Patients with established illness will undergo only 2 scans: baseline and 1 year later.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

168

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Ontario
      • London, Ontario, Canada, N6A 5B7

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Thought Language Index Score between baseline and 6 months
Tidsramme: 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
Tidsramme: 30 months
The time between baseline and remission of positive symptoms based on PANSS-8
30 months
Time to remission of negative symptoms of psychosis
Tidsramme: 30 months
The amount of time between baseline and remission of negative symptoms based on PANSS-8
30 months
Emergence of treatment resistance using operational criteria
Tidsramme: 30 months
30 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Thought Language Index score between baseline and longitudinal follow up-dates (12 months, 18 months, 24 months and 30 months)
Tidsramme: 1-2.5 years
Net change in TLI score as predicted by anatomical abnormalities associated with imaging at various imaging time points.
1-2.5 years
Change in overall symptoms over time
Tidsramme: 30 months
Tracking changes in scores on the PANSS-8 over the 30 months of follow up for first episode patients
30 months
Changes in myelin content
Tidsramme: 30 months (follow up period for first episode patients)
Longitudinal changes in myelin content as measured using quantitative t1 images
30 months (follow up period for first episode patients)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2016

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. december 2023

Datoer for studieregistrering

Først indsendt

24. august 2016

Først indsendt, der opfyldte QC-kriterier

24. august 2016

Først opslået (Skøn)

29. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. februar 2020

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 10014067

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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