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The sponsor decided to terminate the study early on April 21, 2026. No patients were enrolled in this study.
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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.
This is an interventional, prospective, randomized, double-blind, multicenter study, comparing iTBS treatment (experimental group) of the precuneus to placebo stimulation (control group) of patients suffering from resistant schizophrenia and having been exposed to childhood trauma.
The study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments.
This study will be implemented in 4 investigative centers. Each patient will participate for a period of 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group with intermittent Theta Burst Stimulation | Experimental | The procedure under study is the use of a stimulation device to perform intermittent Theta Burst Stimulation treatment on the precuneus to treat resistant schizophrenia. Targeting requires a neuronavigation device. |
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| control group with placebo stimulation | Placebo Comparator | In the control group, stimulation is simulated using a "Sham" or placebo coil. The stimulation device is the same as for the experimental group, only the coil differs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stimulation device | Procedure | The procedure under study is the use of a stimulation device to perform treatment on the precuneus to treat resistant schizophrenia in patients exposed to childhood trauma. The target is the left precuneus, which is defined by neuronavigation. |
| Measure | Description | Time Frame |
|---|---|---|
| average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores | The Primary Outcome Measure will be assessed by the average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores at approximately 21 days compared to the score at inclusion in the two groups. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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interventional, prospective, randomized, double-blind, multicenter study
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Remote coil change while keeping the patient and investigator blind