Clinical evidence & safety
Proliv™Rx was studied in a highly challenging patient population – individuals who had previously failed to achieve adequate response to antidepressant therapy.
It is the first and only at-home neuromodulation therapy to demonstrate significant efficacy in a prospective, randomized controlled clinical trial with patients that have historically been difficult to treat and underserved.
Indication for Use
The Proliv™Rx System provides focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) treatment. It is intended as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for patients use at home or in clinic. The device is a prescription only device.
The MOOD Study: landmark clinical evidence in major depressive disorder
The MOOD study, led by leading psychiatrists in the United States with Dr. Linda Carpenter of Brown University as the lead principal investigator, evaluated the safety and efficacy of Proliv™Rx in adults with Major Depressive Disorder (MDD) who had an inadequate response to antidepressant medication.
Key study characteristics
- Adults with MDD and inadequate response to 1–4 antidepressants
- Randomized, double-blind, sham-controlled design
- Conducted at 13 clinical sites
- 8-week double-blind treatment period (active vs. placebo), followed by an additional 8-week open-label phase with active treatment.
- Participants self-administered the Proliv™Rx therapy at home, completing two 40-minute sessions per day, 5–7 days per week.
Efficacy in patients with prior inadequate response to antidepressants
At Week 8, patients receiving active treatment showed a significantly greater improvement in depression symptoms (reduction of 8.62 points in HDRS-17) compared to placebo (6.01 points; p=0.0196). Continued active treatment led to further improvement, reaching a mean reduction of 9.78 points from baseline at Week 16.
The proportion of patients achieving clinically substantial improvement in HDRS17 score (≥7-point reduction) at week 8 was significantly higher in the active group (61.7%) than in placebo (32.0%; p =0.0034). With continued active treatment, this rate further increased to 70.7% at week 16.
At Week 8, remission rates (HDRS-17 score ≤ 7) were significantly higher in the active treatment group (21.3%) compared to placebo (6.0%; p=0.0273), with patients 4.2 times more likely to achieve remission. With continued active treatment, this rate further increased to 31.7% at week 16.
Improvement in depression severity level
Depression severity levels: Very Severe, Severe, Moderate, Mild, No Depression
Patients receiving active treatment demonstrated shifts to lower depression severity levels at Week 8 and Week 16.
At baseline, 81% of the patients were severe/very severe, compared to only 15% after 16 weeks of active Proliv™Rx treatment.
At baseline, none of the patients were classified as having mild or no depression; after 16 weeks of active Proliv™Rx treatment, 56% reached these levels.
Depression severity levels: Very Severe, Severe, Moderate, Mild, No Depression. After completion of a 16-week therapy program.
Proliv™Rx: key clinical outcomes after antidepressant failure
Favorable safety profile
Proliv™Rx was well tolerated in clinical studies, with no device-related unanticipated serious adverse events reported. Observed adverse events were generally mild to moderate in severity and transient in nature. The most commonly reported adverse events included scalp numbness, localized skin reactions at the electrode sites, and headache.
Clinical Resources & Publications
The MOOD Study Artice: Brain Stimulation Journal
Clinical TMS Society Conference: Poster Presentation
International Brain Stimulation Conference: Poster Presentation
American Psychiatric Association Conference: Poster Presentation
