Midbrain hearing centers and hearing voices in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses unenhanced brain MRI to image the inferior colliculi and adjacent auditory pathways in people with schizophrenia. Participants are grouped into those with recent auditory hallucinations (PANSS P3 ≥ 4 and hallucinations within the past 15 days) and a comparison group with minimal or no hallucinations. Imaging features will be compared with clinical symptom measures to look for structural or functional differences in the midbrain auditory nuclei. The protocol builds on preclinical data showing dopamine D2 receptor expression in the inferior colliculi but addresses a current lack of clinical human data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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

• Patient with a PANSS score (question P3 regarding hallucinations) = 1) AND having not experienced any hallucinations in the past 15 days.

Exclusion Criteria:

* 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)
* Patient participating in an interventional study involving a drug or medical device, or a Category 1 RIPH within 3 months prior to inclusion
* Person under judicial protection
* Pregnant, parturient, or breastfeeding woman
* Person unable to express consent

Where it's running

• CHU de Nîmes, Hôpital Universitaire Carémeau
  Nîmes, France Recruiting

Study contacts

• Principal investigator: Martin Pastre — CHU de Nimes
• Study coordinator: Martin Pastre
• Email: matinpastre@gmail.com
• Phone: 06 95 55 68 80

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.