An interventional study of Unenhanced brain MRI in Schizophrenia and Hallucinations, Auditory, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 40 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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Specific inclusion criteria for the group (SCZ+/HA+) • Patient with a PANSS score (question P3 regarding hallucinations) ≥ 4 (corresponds to PANSS (P3) 4, 5, 6, and 7 patients) AND having experienced hallucinations in the past 15 days.
Specific inclusion criteria for the control group
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
schizophrenic patients experiencing auditory hallucinations
Other: Unenhanced brain MRI
schizophrenic patients without hallucinations
Other: Unenhanced brain MRI
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
Resting state of functional connectivity of the inferior colliculi region with other regions of the auditory network between groups
Measured by MRI
Time frame: Day 0
Default mode network patterns between groups
Measured by MRI
Time frame: Day 0
Neuronal activation in the ICs during exposure to auditory stimuli between groups
Difference in the blood-oxygen level dependent (BOLD) signal measured by functional MRI during an auditory stimulus exposure paradigm in the IC region
Time frame: Day 0
Per-auditory activation in other brain areas between groups
Difference in the BOLD signal measured by functional MRI in other brain areas
Time frame: Day 0
IC metabolite composition between the groups
Difference in the peak magnetic resonance spectrometry (sMRI) signal
Time frame: Day 0
Structural connectivity via white matter between ICs and other auditory network structures between groups
Difference in structural connectivity using DTI (diffusion tensor imaging, anisotropy fraction calculation, mean diffusivity, and tractography) from the ICs
Time frame: Day 0
Correlation between BOLD signal and psychopathological symptoms
Measured by Positive and Negative Syndrome Scale (PANSS), providing a negative symptomatology score ranging from 7 to 49, and a general psychopathology score ranging from 16 to 112, with a total score ranging from 30 to 210.
Time frame: Day 0
Correlation between BOLD signal and severity of delusions and hallucinations
Measured by Psychotic Symptom Rating Scale (PSYRATS), an 11-item scale where each symptom is rated from 0 to 4 depending on the intensity
Time frame: Day 0
Correlation between BOLD signal and doses of antipsychotic treatment
Antipsychotic doses calculated by olanzapine equivalent method
Time frame: Day 0
Difference in perauditory activation and functional connectivity (resting-state) in SCZ+ HA+ patients who hallucinated during the procedure and those who did not
Measured via post-hoc task-based, BOLD signal state hallucination analysis
Time frame: Day 0
Correlation between BOLD signal and dissociation symptoms
Measured by Dissociative Experience Scale (DES)
Time frame: Day 0
Correlation between BOLD signal and severity of somatoform manifestations of dissociation
Measured by Somatoform Dissociation Questionnaire (SDQ)
Time frame: Day 0
Correlation between BOLD signal and clinically assessed states of dissociation
Measured by Clinician Administered Dissociative States Scale (CADSS), a 5-point Likert scale
Time frame: Day 0
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 12 months is below that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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