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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder \(MDD
- Sponsor
- Neurovalens Ltd.
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Hamilton Depression Rating Scale (HDRS-17)
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •A Generalized Anxiety Disorder (GAD-7) score \<10 at screening
- •On anti-depressant medication to treat depression (participant must only be on one Selective Serotonin or Norepinephrine Reuptake Inhibitor (SSRI/SNRI) for at least 1 year prior to baseline visit, and no longer than 5 years)
- •Stable dose of current prescribed antidepressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
- •Maintain a stable prescribed medication and/or treatment regime to treat depression for the duration of the trial
- •No change in regular medication for the duration of the trial (unless directed by a health care provider).
- •Can speak / read English
Exclusion Criteria
- •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
- •Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
- •Female who is pregnant or breast-feeding
- •History of diagnosed cognitive impairment / disorder such as delirium or dementia
- •Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy).
- •History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation)
- •Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HDRS-17)
Time Frame: 6 weeks
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit. The proportion (%) of participants achieving the HDRS-17 minimal clinically important difference (≥3 point reduction) by the 6-week time point between the active and sham groups.
Secondary Outcomes
- Hamilton Depression Rating Scale (HDRS-17)(Change in score at 4 week post-intervention timepoint)
- Quality of Life (EQ-5D-5L)(Change in score from baseline to 6 weeks)
- WHO Disability Assessment Schedule 2.0 (WHODAS2)(Change in score at 4 week post-intervention timepoint)
- Insomnia Severity Index (ISI)(Change in score from baseline to 6 weeks)