Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia

NCT01176721 | Completed Phase 2 DMC

• 1 other identifier: 02VNS2009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia

Keywords

schizophrenic disorders; psychosis; psychotic; dementia; delusional; delusions; hallucinations; residual-type schizophrenia; illusions; split mind; mental health disorder; schizoid; paranoid-type schizophrenia; disorganized-type schizophrenia; undifferentiated-type schizophrenia; catatonic-type schizophrenia; mental illness; tardive dyskinesia; neuroleptic malignant syndrome; NMS; antipsychotics; atypical antipsychotics; psychosocial treatments; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy of t-VNS in schizophrenia

  24 weeks

Secondary Outcomes (1)

• Recording of clinical performance of t-VNS in schizophrenia

  24 weeks

Study Arms (2)

t-VNS verum

ACTIVE COMPARATOR

Active stimulation of the left auricle by t-VNS

Device: t-VNS verum

Sham

PLACEBO COMPARATOR

Sham-simulation of the left auricle by the t-VNS device.

Device: t-VNS placebo

Interventions

t-VNS verum DEVICE

Active stimulation of the left auricle by t-VNS

t-VNS verum

t-VNS placebo DEVICE

Sham stimulation of the left auricle with the t-VNS device

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
• Appliance of the t-VNS® medical device according to the manual

You may not qualify if:

• Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
• Pregnancy
• Bronchial asthhma in medical history
• clinically relevant internistic, neurological or psychiatric diseases
• abuse of drugs or alcohol until 4 weeks to enrollment
• Traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (Gammma knife surgery))
• indication of structural impairment of the basal ganglia or the brain stem
• malformations of the pinna
• further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study

Sponsors & Collaborators

• cerbomed GmbH: lead
• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: collaborator

Study Sites (2)

Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen

Munich, Bavaria, 80336, Germany

Location

Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen

Göttingen, Lower Saxony, 37075, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders; Dementia; Delusions; Hallucinations; Illusions; Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Catatonic; Tardive Dyskinesia; Neuroleptic Malignant Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Behavioral Symptoms; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Basal Ganglia Diseases; Neurotoxicity Syndromes; Poisoning; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2012
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

DE (2)