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| Name | Class |
|---|---|
| Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH | OTHER |
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Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| t-VNS verum | Active Comparator | Active stimulation of the left auricle by t-VNS |
|
| Sham | Placebo Comparator | Sham-simulation of the left auricle by the t-VNS device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t-VNS verum | Device | Active stimulation of the left auricle by t-VNS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy of t-VNS in schizophrenia | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of clinical performance of t-VNS in schizophrenia | self rating:
rating by investigator
| 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen | Munich | Bavaria | 80336 | Germany | ||
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D003702 | Delusions |
| D006212 | Hallucinations |
| D007088 | Illusions |
| D012563 | Schizophrenia, Paranoid |
| D012562 | Schizophrenia, Disorganized |
| D012560 | Schizophrenia, Catatonic |
| D000071057 | Tardive Dyskinesia |
| D009459 | Neuroleptic Malignant Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| t-VNS placebo |
| Device |
Sham stimulation of the left auricle with the t-VNS device |
|
| Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen |
| Göttingen |
| Lower Saxony |
| 37075 |
| Germany |
| D019965 | Neurocognitive Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D001480 | Basal Ganglia Diseases |
| D020258 | Neurotoxicity Syndromes |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |