Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNeurovalens Ltd.
About this trial
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , as compared to a sham control.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation
Eligibility criteria
Qualifiers
Signed Informed Consent
Adults, (US ≥ 22 years and ≤ 80 years, UK ≥ 18 years and ≤ 80 years) male or female at the time of signing informed consent
Beck's Depression Inventory-ll (BDI-ll) score of ≥ 14 at Screening
Established diagnosis of depression as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI)
Disqualifiers
Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)
Diagnosis or history of bipolar disorder
History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
Diagnosis of substance use disorder within the past 12 months or current substance use dependence
Trial design
Treatments tested in this trial
- Active VeNS Device
- Sham VeNS Device
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov