Depression is the leading cause of disability worldwide, affecting more than 300 million people of all ages around the world. The most commonly used antidepressant medications are called selective serotonin reuptake inhibitors (SSRIs). Only about  one third of people with major depressive disorder achieve remission after treatment with SSRIs. When the first medication doesn’t work, the next steps are usually to switch to or add another SSRI medication. After trying different options or combinations, almost 70% of people with depression will be able to achieve remission. Unfortunately, the remaining 30% of people will not be able to find a treatment that works, and are said to have treatment resistant depression.

Ketamine was first approved for use as an anesthetic in 1970 and was later abused as a party drug, thereby creating a stigma surrounding its use in a medical setting. After a series of studies in the early 2000s, scientists began investigating ketamine for its rapid-acting antidepressant effects. Subsequent studies showed promising results and, last week, the FDA approved the use of the nasal spray Spravato, the first ketamine-based antidepressant for patients who haven’t responded to two or more SSRI antidepressants. Unlike SSRIs, which can take weeks or months to begin taking effect, a single dose of ketamine was found to produce antidepressant effects within a few hours and lasted at least one week after the single treatment. To avoid recreational use of the medication, the FDA has only made the drug available through a restricted distribution system. The drug will be administered under supervision of healthcare professionals and patients will be monitored for two hours after treatment for potential side effects.

In a space that has been limited to the use of SSRIs, this opens up many new opportunities for the treatment for depression. At the same time, safety and caution are very important. Typically, antidepressants are approved on the basis of two positive short-term trials. However, since the benefits outweighed the associated risks, the FDA advisory committee voted to approve the drug after only one positive trial. Additional, larger clinical trials are needed to assess long term safety and efficacy of ketamine-based antidepressants. It will also be important to maintain perspective throughout the hype around ketamine in the media. In the excitement, patients have begun to think of ketamine as a miracle drug, requesting it before standard SSRI treatments. Whether ketamine-based antidepressants are more effective than SSRIs, for safe and successful treatment of depression, remains to be investigated.

Managing Correspondent: Jeremy Gungabeesoon

News Article: A Ketamine-Based Nasal Spray For Depression Has Just Been Approved by The FDA. ScienceAlert

Original Article: FDA approves new nasal spray medication for treatment-resistant depression. FDA News Release

Image Credit: Wikimedia Commons

5 thoughts on “FDA approves first ketamine-based antidepressant

  1. I’m suffering from a serious relapse of PTSD. My depression and anxiety are treatment resistant. SSRI’s never helped. I’m having end to end panic attacks nearly every day. My story is a long painful one. Vicious ex husband (now in prison for murder) and I lost my son to his insanity.

    I’m TRYING so hard to get help. Can’t get into see a psychiatrist until January. Do want to no longer be here but can’t do that to my loved ones. So I suffer on and on and on. Lost 25 pounds in 2 months. Nearly constant nausea, vomiting bile because the food I make myself eat makes me feel sicker.

    I’m 65. I have fibromyalgia (which most doctors STILL look at with a jaundiced eye. So I’m in constant physical pain as well as emotional and mental pain. Don’t know how much longer I can do this.

    I’m also pretty poor. Worked for 25 years as a graphic designer creating educational media for Naval aviators. But had to go on SSDI.

    Is ANYONE listening?

    1. Our lives are so similar and all your feelings stated, I have felt and still cycle through them 3 to 6 months so a time with only a month, 2 tops, of not being depressed too the point of wishing I don’t wake up next morning, and I’ve thought and planned suicide but can’t because it’s hard, so hard and painful (I’ve tried once and won’t again for to pain and embarrassment and labeled forever by my family who says ‘it’s the past’, yet they say things that hurt, about that time, age 47 . I’m 58, struggling like you, laden heavily with misconceptions and stigmas and have an empathetic PCP who does his best in this time awful time of blaming, vilifying Doctors where insurance companies and pharmacies try to be the doctor and try to prevent my prescription from being continued, despite my being on it over 12 years, all proven by MRI, C-scans, X-rays, along with 15 years diagnosed Major Depression, PTSD, ANXIETY d/o, and I’ve tried 9 major antidepressants over 12 years, started at she 36, to find out if I’m lucky, nothing happens and it doesn’t work (only once) to getting horrible adverse effects that increase suicidal ideation and I’m not a test or elderly during these times and before they started warning about that. I’ve stopped being a guinea pig for last 8 years and will remain so.
      I’ve read tons about Ketamine and how it’s given and the stigma attached to it… I feel it’s a poor option, UNLESS, like a cancer patient, in chronic pain and will die within a year or few..
      then I say, give them whatever makes them comfortable and happy while alive.
      If that’s not you, my opinion only combined with my experience as a clinical lab tech working in hospitals 30 years, then changed careers to substance abuse counselor, I’ve seen horrors caused by these stronger than oxycodone meds…. It is originally an anesthetic, like Fentynal originally used for. Ketamine and these class of serious drugs scare me, despite all my self negative thoughts.
      Please be careful. I looked up a clinic that dispenses Ketamine via IV FOR 40 minutes at $500 and the Dr told me I’d need 6 doses in one month and if need 2 more months of the same at least before is be almost set for 9 months until my depression came back. I asked tons of questions and confirmed I was speaking with a DRUG DEALER right up there with Cartel Ethics! He actually said Ketamine is not addictive and he had that sentence on his medical treatment site! He called me 2 more days to try and recruit me. Insurance won’t pay. I asked why several different ways until he truthfully told me it’s been approved by FDA(which means nothing for our protection, research it. My college professors in clinical science taught us this in 1980 & I didn’t believe it until my 30’s when I was more aware.
      I feel (minus someone on their way to don’t from a painful emotionally and physically disease soon) it’s a monstrous misuse of Hippocratic oath and that those who pay the exorbitant cost are paying for the research using humans (you!), not mice, etc… Greedy pharmaceutical company making Ketamine,

  2. Wow Rebecca. Sorry you are having a very hard time. I understand how you feel , i have been through alot myself and have had plenty of counseling. It didn’t really help me that much. I have been on and off depression meds since I was 20. I’m 61 now. So what i have been doing is reading self help books and trying to retrain my brain to think positive. Its a struggle every day and I get that. Ive always had trouble with self esteem. Its been very detrimental in finding a good paying job. I understand what you’re going through and I hope and pray that what I have said can help you in some way. Medication and is just a band aid to get through the day, i don’t feel like it’s enough. Please take good care of yourself and i hope you can get better. Help yourself as much as you can.

    1. Sounds like or similar to myself. Hope this new stuff works…I’m feeling just like you stated yourself and wish I could offer help, but can’t.

  3. I have suffered my entire life with trauma after trauma, it’s caused PTSD as well as major depression, anxiety and panic disorder. I’d like to know if this is available in Canada and if yes, how would one go about finding more out about it?? Thank you, Candis

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