The holiday times are joyful for many but a substantial number of people experience sadness this time of year. This especially is true post-holidays when “Seasonal Affective Disorder” afflicts millions. I would bet that almost everyone reading this entry had experienced bouts of sadness in the past but clinical depression is a much more intense sensation and severe cases may lead to life-altering events such as hospitalizations and even suicide.
I have been practicing medicine for over 40 years and I have seen a number of FDA-approved medications launched (and then often disappear) that claim “breakthroughs” in the treatment of depression. Reality? Success rates of these medications are usually around 66% and placebo response in those FDA studies is around 58%. Basically a multibillion dollar a year seller like Prozac is basically about 8% better than a sugar pill.
The FDA recently approved the Flow FL-100 headset, the first at-home brain stimulation device for moderate-to-severe depression, using transcranial direct current stimulation (tDCS) to deliver gentle electrical currents to the prefrontal cortex to regulate mood. This prescription-only device, from Flow Neuroscience, offers a non-drug alternative, usable alone or with medication, and is expected to launch in the U.S. in 2026
The FDA’s approval of this brain-stimulation device was based on the Empower phase 2 study showing 58% of patients achieved remission of their depression after 10 weeks. Flow Neuroscience shared that among global users of the device, 77% reported improvement in their symptoms within 3 weeks. The company also noted that over 55,000 patients have used the device across Europe, the UK, Switzerland, and Hong Kong.
It appears that the use of the device does not cause any major side effects and this certainly would be a welcome relief to those people on SSRIs (Zoloft, Lexapro, Prozac), SNIs (Effexor, Pristiq) and other oral medications that are used to treat depression yet carry a number of potential side effects.
The treatment of depression has been very disappointing to date and my opinion is that the medical world still does not have great knowledge as to the neurotransmitter imbalances that lead to mood disorders. Perhaps the new device will help many people that do not respond to oral medications.
We all would rather see a loved one’s happy eyes and not sad eyes. Here is an oldie from Robert John.
