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New treatment option for Treatment Resistant Schizophrenia
Official title Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
ClinicalTrials.gov ID: NCT06361160
What this study is testing
- What it's testing
- Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years old
- Schizophrenic Disorder (Diagnostic and statistical manual of mental disorders, DSM-5-TR, American Psychiatric Association, 2013)
- AVHs that have resisted to at least two properly conducted antipsychotic therapies at an effective dose for at least 8 weeks (criteria of Kinon et...
- Frequent AVHs (at least 10 times per hour) (Fovet et al., 2022)
- Unmodified antipsychotic dosage for 30 days prior to inclusion in the protocol
You likely can't join if
- Pregnancy (based on date of last menstrual period with possibility of urine test if in doubt)
- Anticonvulsant therapy
- Neurological disorder (e.g., multiple sclerosis, epilepsy)
- Current addictive behavior (except tobacco and cannabis, widely used in this clinical population; Fovet et al., 2022)
- Contraindication to MRI (i.e., presence of ferromagnetic material or implanted neurostimulation devices due to the risk of displacement or...
- Morphological criteria: weight \> 130 Kg, abdominal circumference conditioned by the opening of the magnet, shoulder width
See the full eligibility criteria
- Age \> 18 years old
- Schizophrenic Disorder (Diagnostic and statistical manual of mental disorders, DSM-5-TR, American Psychiatric Association, 2013)
- AVHs that have resisted to at least two properly conducted antipsychotic therapies at an effective dose for at least 8 weeks (criteria of Kinon et al., 1993)
- Frequent AVHs (at least 10 times per hour) (Fovet et al., 2022)
- Unmodified antipsychotic dosage for 30 days prior to inclusion in the protocol
- AVH are the main residual symptom of schizophrenia.
- Consent to participate in the study
- Pregnancy (based on date of last menstrual period with possibility of urine test if in doubt)
- Anticonvulsant therapy
- Neurological disorder (e.g., multiple sclerosis, epilepsy)
- Current addictive behavior (except tobacco and cannabis, widely used in this clinical population; Fovet et al., 2022)
- Contraindication to MRI (i.e., presence of ferromagnetic material or implanted neurostimulation devices due to the risk of displacement or dysfunction such as cochlear implants, cardiac pacemakers, metal splinters in...
- Morphological criteria: weight \> 130 Kg, abdominal circumference conditioned by the opening of the magnet, shoulder width
- Lack of coverage by the social security system
- Current participation in another treatment research protocol or being in the exclusion period of a previous research protocol
- Refusal to be informed of an brain anomaly detected in the MRI
- Person under guardianship or curatorship
- Behavioral disorders or delusions likely to prevent the MRI or rTMS from being performed under good conditions (left to the discretion of the investigator at baseline).
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.