FAQ

Is this FDA approved?

Yes — Ketamine is FDA approved as an anaesthetic, and not yet as a depression aid.



Can my doctor prescribe this for depression legally?

Yes — Ketamine is FDA approved. Off-label prescription means a physician can prescribe Ketamine "when they judge that it is medically appropriate for their patient."



Why isn't this yet a widespread treatment?

Because Ketamine for depression is still in Phase 2 trials with the FDA. However the FDA has granted "breakthrough therapy status" to esKetamine (on August 16, 2016), which would speed the approval process for depression.



Why is Ketamine still in Phase 2 trials?

Ketamine's patent has expired. This means drug companies will find it difficult to make lots of money from selling it, compared to other patentable drugs. The government funds Phase 2 research for Ketamine via grants, however the cost of a Phase 3 trial is so high that government grants are not sufficient to fund this work. There are only two paths for Ketamine being FDA approved for depression: a) a drug company develops a similar drug that works the same way as Ketamine, but is different enough that they can patent it and make lots of money (this is what is happening with esKetamine) or b) a wealthy individual funds the Ketamine Phase 3 trials out of the goodness of their own heart.



What protocols and dosages are used in research?

Almost all use 0.5-mg/kg dosages. Most studies are done intravenously. Some studies do Monday-Wednesday-Friday infusions.



Is there research on oral Ketamine, instead of nasal or IV?

One study used 0.5-mg/kg daily and found significant improvement in both depressive symptoms and symptoms of anxiety in all eight subjects. Dosage was daily. Depression symptoms improved significantly by day 14 until the end (day 28), and anxiey symptoms improved significantly by day 3 until the end (day 28). "The response rate for depression is similar to those found with IV Ketamine; however, the time to response is more protracted." — basically, it worked similarly well for depression as IV Ketamine, though took longer to take effect.[4]



What are the side effects?

"None of the studies included in the current meta-analysis documented major adverse effects, but side effects such as transient headache, dizziness and nausea were commonly reported; such side effects reportedly dissipated fairly quickly, usually once the infusion was complete."[2]



What are the worst things about this? Why might this not work?

"Middle- and long-term efficacy and safety have yet to be explored. Extrapolation should be cautious: Patients included had no history of psychotic episodes and no history of alcohol or substance use disorders, which is not representative of all the depressed patients that may benefit from this therapy."[3] Also, it's important to realize that one dose won't solve your depression forever.



Does Ketamine work for everyone who has depression?

No. Seems like it works for around ~70% of people in research so far.[2]