NCT05206292

Brief Summary

Screening for sulfur amino acid metabolism pathologies using a sulfitest in adult patients with psychotic disorder.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

January 6, 2022

Last Update Submit

May 31, 2024

Conditions

Inherited Metabolic Disorder of Nervous SystemSchizophrenia

Keywords

NIT1SulfitestInherited Metabolic DisorderPsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of positive sulfitests (compared to the number of patients included).

    Sulfitest is considered positive if clearly colored.

    15 minutes

Secondary Outcomes (2)

  • Sulfite concentration in urine (semi-quantitative scale).

    15 minutes

  • Clinical characteristics of patients with a positive sulfitest.

    15 minutes

Study Arms (1)

Patient cohort

OTHER

There is only one patient arm. It corresponds to the cohort of included patients, all of whom had psychotic disorders with no known organic etiology.

Diagnostic Test: Sulfitest

Interventions

SulfitestDIAGNOSTIC_TEST

Urine strip to detect the presence of sulfites in urine. Immediate result.

Patient cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18 years of age and older,
  • Followed for a psychotic disorder,
  • With no known organic etiology for the psychotic disorder,
  • Not having formulated its opposition to participation in the study (or his/her tutor/curator),
  • Affiliated with the social security system.

You may not qualify if:

  • Patients protected by law (minors, pregnant or breastfeeding women, deprived of liberty or hospitalized under constraint, under administrative or judicial supervision) except patients under tutorship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related Publications (5)

  • Perala J, Suvisaari J, Saarni SI, Kuoppasalmi K, Isometsa E, Pirkola S, Partonen T, Tuulio-Henriksson A, Hintikka J, Kieseppa T, Harkanen T, Koskinen S, Lonnqvist J. Lifetime prevalence of psychotic and bipolar I disorders in a general population. Arch Gen Psychiatry. 2007 Jan;64(1):19-28. doi: 10.1001/archpsyc.64.1.19.

    PMID: 17199051RESULT

  • Sedel F, Baumann N, Turpin JC, Lyon-Caen O, Saudubray JM, Cohen D. Psychiatric manifestations revealing inborn errors of metabolism in adolescents and adults. J Inherit Metab Dis. 2007 Oct;30(5):631-41. doi: 10.1007/s10545-007-0661-4. Epub 2007 Aug 10.

    PMID: 17694356RESULT

  • Rendu J, Van Noolen L, Garrel C, Brocard J, Marty I, Corne C, Faure J, Besson G. Familial deep cavitating state with a glutathione metabolism defect. Ann Clin Transl Neurol. 2019 Dec;6(12):2573-2578. doi: 10.1002/acn3.50933. Epub 2019 Nov 9.

    PMID: 31705625RESULT

  • Peracchi A, Veiga-da-Cunha M, Kuhara T, Ellens KW, Paczia N, Stroobant V, Seliga AK, Marlaire S, Jaisson S, Bommer GT, Sun J, Huebner K, Linster CL, Cooper AJL, Van Schaftingen E. Nit1 is a metabolite repair enzyme that hydrolyzes deaminated glutathione. Proc Natl Acad Sci U S A. 2017 Apr 18;114(16):E3233-E3242. doi: 10.1073/pnas.1613736114. Epub 2017 Apr 3.

    PMID: 28373563RESULT

  • Misko AL, Liang Y, Kohl JB, Eichler F. Delineating the phenotypic spectrum of sulfite oxidase and molybdenum cofactor deficiency. Neurol Genet. 2020 Jul 14;6(4):e486. doi: 10.1212/NXG.0000000000000486. eCollection 2020 Aug.

    PMID: 32802950RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Gérard Besson

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gauthier Willaume

CONTACT

+33 4 76 76 57 92gwillaume@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Adult patients with psychotic disorder without known organic cause.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 25, 2022

Study Start

January 12, 2023

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)