Results Show an Alternative Twice as Effective Compared to Antidepressant Medications
LONDON, July 31, 2023 /PRNewswire/ -- Flow Neuroscience, the creators of the Flow tDCS headset that provides at-home non-invasive brain stimulation to treat depression, today announced the results of its FDA pivotal clinical trial. The trial results show that the Flow headset was twice as effective as the most commonly-prescribed antidepressants in the treatment of depression.*
In July 2022, Flow received FDA Breakthrough Device Designation, demonstrating the innovative nature of the platform and the significant advantages it offers over existing approved or cleared alternatives. It was the first medical device in the category to achieve this status. Flow is now being reviewed for full FDA approval, which would make this device available as an at-home treatment option in the U.S.
In a study of patients in the US and the UK, the largest-ever clinical trial of its kind, 56% of the participants using the Flow tDCS headset were relieved of all depressive symptoms within 10 weeks**. Daily use of Flow was confirmed to be safe with minimal side effects.
Flow has already been granted regulatory approval in Europe where it is available over the counter via Flow's website and in major UK pharmacies. More than 12,000 people and 100 clinics/hospitals in Europe use Flow today, including NHS partnerships.
Preliminary results include:
The trial sites at the University of Texas and the University of East London measured the effectiveness and safety of the tDCS headset designed by Flow Neuroscience.
173 patients were taken through the at-home treatment program, completely remotely and with minimal supervision, over a 10-week period. This was the largest ever US/UK tDCS study for the treatment of depression.
56% of patients in the treatment group went into remission (complete relief from depression symptoms), and 62% had a clinical response (more than 50% improvement in depressive symptoms.)**
The study showed that participants had greater than three times higher odds of getting substantially better if they got the active treatment vs if they got placebo/sham stimulation, approximately double the average effect size witnessed in the trials for the 21 best-selling antidepressants reviewed by the FDA.
No major side effects were reported from the treatment group.
Flow's study results come at a time when depression is at an all-time high among U.S. adults, but with nearly half of Americans in 2021 reporting they did not seek help for clinical-level mental health issues, citing an increased desire for self-help options. The Flow tDCS headset and treatment is conveniently administered at home five times a week, creating an effective, safe, and accessible treatment option for depression.
How Flow works:
The Flow headset uses a brain-stimulation technique called tDCS to target the left dorsolateral prefrontal cortex, which is the area of the brain associated with depression.
Depression is associated with lowered activity in the Dorsolateral Prefrontal Cortex (DLPFC). This area of the brain helps regulate mood, and focus, and can even impact sleep and appetite. When this area of the brain has lower activity, these functions are affected.
By delivering a weak electrical current (2 mA) to the DLPFC via electrodes placed on the forehead, activity increases in this part of the brain. This addresses what some researchers believe is one of the physical causes of depression.
Since Flow can target specific brain areas involved in depression directly, users experience little to no side effects compared to antidepressants.
Allan Young (Chair of Mood Disorders, Director of Centre for Affective Disorders in the Institute of Psychiatry, Psychology, and Neuroscience at King's College London) said: "These exciting and encouraging new data raise the prospect of a real advance in the treatment of depression. Major depression is undertreated throughout the world, and all of the currently widely used treatment modalities have significant limitations. The nature of this treatment, being both effective and well tolerated, means that it is a treatment which may be widely adopted and should be a helpful intervention for many people suffering from major depression."
Azhar Zafar (GPA Director of Research, NHS GP, and Senior Lecturer at the University of Buckingham) said: "These findings are incredibly promising and align with the valuable insights gained from utilizing Flow in primary care. Flow has gained significant popularity among our NHS patients, and a considerable number of them willingly opt for Flow when presented with the choice for the treatment of depression with or without pharmacotherapy. This positive reception speaks volumes about the effectiveness and patient satisfaction associated with Flow."
Flow Neuroscience co-founder Daniel Månsson said: "Depression is one of the most common mood disorders, and unfortunately, it is also one of the hardest to treat. Our core mission was to create a treatment that is effective and accessible to as many people as possible in their own homes, with little to no side effects. The results of this clinical trial show how effective this treatment has become and how breakthroughs are still possible in the treatment of depression."
Corey Keller (Assistant Professor of Psychiatry and Behavioral Sciences at Stanford University) said: 'These results show clear separation of active and sham treatment arms in a large, multisite, randomized controlled trial for at-home low-intensity brain stimulation for depression. Flow's novel brain stimulation approach could offer valuable opportunities for individuals to manage their depression from home effectively, signaling a very promising development in mental health treatment.'
Visit to find out more information about Flow's first at-home depression treatment.
Key Stats about Flow Neuroscience:
12,000+ real-world users in UK and Europe
Live in 100+ clinics and hospitals in UK and Europe
8 million minutes of stimulation using the Flow headset and over 260,000 stimulation sessions
Flow attracts users from all ages and walks of life, with over one-third of users above 50 years of age
More About Flow Neuroscience
Founded in 2016, Flow Neuroscience's mission is to develop new ways to combat mental health issues with science and technology. The Flow headset is a medication-free treatment for depression, the leading cause of disability in the world. It combines a brain stimulation wearable and an app-based therapy program to create a new effective, safe, and affordable way to treat depression, at home. The Flow headset offers a treatment you can take with you from your home to your office to your everyday. On average, the majority of Flow headset users see significant improvements within 4 to 6 weeks of treatment.
Notes to Editors:
*Based on a comparison of odds ratios, a standardized way of comparing clinical trials and a form of measurement for the difference in effect between treatment and placebo. The study showed that participants had greater than three times higher odds of getting substantially better if they got the active treatment vs if they got placebo/sham stimulation, approximately double the average effect size witnessed in the trials for the 21 best-selling antidepressants reviewed by the FDA.
**Measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The trial was also measured by the Hamilton Depression Rating Scale (HDRS-17), and results demonstrated 45% clinical remission and 55% had an improvement of at least 50%.
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