NCT07003529

Brief Summary

The neural basis of auditory hallucinations (AH) in patients with schizophrenia is poorly characterized. Functional imaging studies investigate either the "state" dimension (i.e., the measurement of changes in brain area activation at the precise moment of AH onset) or the "trait" dimension (i.e., the neural correlates of the propensity to hallucinate). A corollary of AH (particularly acoustic-verbal) is the activation of brain regions involved in the auditory perception of speech (auditory cortex). One theory is that patients with schizophrenia with AH may have a deficit in processing their internal speech (i.e., external attribution to internal verbal content). However, there is little clinical data on the specific role of the mesencephalic region of the inferior colliculi (IC) in the formation of these symptoms. Preliminary research has shown intense expression of dopamine D2 receptors, particularly on glutamatergic neurons in mouse ICs. Thus, ICs receive numerous inhibitory dopaminergic inputs, likely involved in signal optimization and modulation. The study authors hypothesize that AHs are the result of a defect in signal inhibition by the IC, which lose their function as perceptual filters.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
4mo left

Started Sep 2025

Shorter than P25 for not_applicable schizophrenia

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

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Study Timeline

Key milestones and dates

Study Progress67%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

May 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 9, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

May 20, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Resting state of functional connectivity of the inferior colliculi region with other regions of the auditory network between groups

    Measured by MRI

    Day 0

  • Default mode network patterns between groups

    Measured by MRI

    Day 0

Secondary Outcomes (11)

  • Neuronal activation in the ICs during exposure to auditory stimuli between groups

    Day 0

  • Per-auditory activation in other brain areas between groups

    Day 0

  • IC metabolite composition between the groups

    Day 0

  • Structural connectivity via white matter between ICs and other auditory network structures between groups

    Day 0

  • Correlation between BOLD signal and psychopathological symptoms

    Day 0

  • +6 more secondary outcomes

Study Arms (2)

Patient Group (SCZ+/AH+)

EXPERIMENTAL

schizophrenic patients experiencing auditory hallucinations

Other: Unenhanced brain MRI

Control Group (SCZ+/AH-)

EXPERIMENTAL

schizophrenic patients without hallucinations

Other: Unenhanced brain MRI

Interventions

Unenhanced brain MRI in five sequences: 1) T1-weighted anatomical sequences 2) Resting-state functional sequences 3) Task-based functional sequence 4) Structural sequence using Diffusion Tensor Imaging (DTI) 5) Routine magnetic resonance spectroscopy sequence

Control Group (SCZ+/AH-)Patient Group (SCZ+/AH+)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • DSM-5 diagnosis of schizophrenic disorder (based on clinical assessment and confirmed by the MINI 7.0 interview)
  • Patient with a schizophrenic disorder lasting ≤ 20 years
  • Patient treated in a psychiatric unit as an inpatient (in non-specialized care) or outpatient or under a mandatory ambulatory psychiatric care programme
  • Clinical condition compatible with imaging based on clinical judgment
  • Ability to understand, write, and read French
  • Patient with a PANSS score (question P3 regarding hallucinations) = 1) AND having not experienced any hallucinations in the past 15 days.

You may not qualify if:

  • The patient is under safeguard of justice or state guardianship
  • Contraindications to magnetic resonance imaging, including severe claustrophobia, based on clinical judgment.
  • Congenital or acquired deafness
  • Suicide risk, based on clinical judgment
  • Patient with moderate to severe intellectual disability, based on medical records
  • Patient with moderate to severe neurocognitive disorders, based on medical records
  • Patient receiving anticholinergic therapy (biperiden-Akineton, trihexyphenidyl-Artane, tropatepine-Lepticur)
  • Person under judicial protection
  • Pregnant, parturient, or breastfeeding woman
  • Person unable to express consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Pastre

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 4, 2025

Study Start

September 12, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 9, 2025

Record last verified: 2025-08

Locations