- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02882204
Tracking Outcomes in Psychosis (TOPSY)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lena Palaniyappan, MD, PhD
- Numéro de téléphone: 519.685.8054
- E-mail: lena.palaniyappan.@lhsc.on.ca
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6A 5B7
- Recrutement
- Robarts Research
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Contact:
- Lena Palaniyappan, MBBS, PhD
- Numéro de téléphone: 519-685-8054
- E-mail: lena.palaniyappan@lhsc.on.ca
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Study population includes two groups of individuals:
- First Episode psychotic patients: This group will contain 84 new patients enrolled in the Prevention and early Intervention Program for Psychosis.
- Chronic Patients: This group will contain 42 patients who have been enrolled in the Prevention and Early Intervention Program for Psychosis for >3 years.
- Healthy Controls: This group will contain 42 healthy controls not being treated for a major mental illness defined using DSM-V criteria.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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First Episode Patients
First episode patients new to the PEPP program.
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Chronic Patients
Existing patients who have been enrolled in the PEPP program for >3 years
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Healthy Controls
Healthy controls who are not currently in treatment for any major mental illness defined using DSM-V criteria.
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Cliniucal High Risk patients
Patients who are accessing PEPP services during the prodromal phase of psychotic illness.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Thought Language Index Score between baseline and 6 months
Délai: 6 Months
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Predicting the change in TLI score based on baseline anatomical abnormalities identified through MRI
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6 Months
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Time to remission of positive symptoms of psychosis
Délai: 30 months
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The time between baseline and remission of positive symptoms based on PANSS-8
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30 months
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Time to remission of negative symptoms of psychosis
Délai: 30 months
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The amount of time between baseline and remission of negative symptoms based on PANSS-8
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30 months
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Emergence of treatment resistance using operational criteria
Délai: 30 months
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30 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Thought Language Index score between baseline and longitudinal follow up-dates (12 months, 18 months, 24 months and 30 months)
Délai: 1-2.5 years
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Net change in TLI score as predicted by anatomical abnormalities associated with imaging at various imaging time points.
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1-2.5 years
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Change in overall symptoms over time
Délai: 30 months
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Tracking changes in scores on the PANSS-8 over the 30 months of follow up for first episode patients
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30 months
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Changes in myelin content
Délai: 30 months (follow up period for first episode patients)
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Longitudinal changes in myelin content as measured using quantitative t1 images
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30 months (follow up period for first episode patients)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5®) (2013).
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10014067
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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