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New to Bluelight - Esketamine Trial - Negative Side Effects

Loopy Snoopy

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Joined
Oct 10, 2017
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4
Hi all,

I am totally new to Bluelight - found it through a Google search. I am currently doing a US clinical trial for Intranasal Esketamine in Treatment-Resistant Depression. The sponsor is Janssen Research & Development LLC. I am currently in the 2nd phase of this study.

The reason I am posting is because for the first time I have had a worrying reaction to the medication. In Phase 1, it was either placebo or esketamine for participants. It was double-blind so neither I nor the staff knew what I was really getting but the fact that I was obviously "tripping" for the first time in my life (I'm not a recreational drug user) made it pretty clear to me that I was not getting the placebo. I was supposedly getting (if not on the placebo) 84 mg (6 squirts of the spray) 2x/week at their site. This was the maximum dose for the study. A couple of times I had a very mild hangover effect (without headache) the day after but that soon resolved and it was not worrisome. I had dizziness during the "tripping" part but it ALWAYS went away by the time 2 hours had passed. This was a very common and expected side effect for many recipients of the drug.

Now I am in Phase 2 and it has been a different experience. This phase is "open label" so both the study coordinators and I know I am definitely getting the esketamine. I am now on less - 56mg - of the drug yet tolerating it has been more difficult. This would lead one to believe I was actually getting the placebo in Phase 1 but I asked the study coordinators if the placebo had ANY sedative effects since during Phase 1 the "trip" made me severely drowsy. They said the placebo was completely inert - no active substances, no mimicking of the actual drug. Even though I can't confirm, I strongly believe I was on the full dose esketamine and not placebo because I had many of the symptoms of what "tripping" is.

So I received a "low" dose of 56 mg on Oct 5th and woke up on Oct 7th with the following symptoms:


  • "Hangover" feeling
  • Significant dizziness
  • Nausea - Persistent and unrelated to food/drink
  • Fatigue - Could not go more than a few hours without feeling a big energy drain
  • Headache - Lower back of head only
  • Severe sleep disruption
  • Brain fog / feeling slow in the head
  • Some mild irritation in my head when moving my eyes
  • Mild anxiety (unrelated to depression)

It seems I had a delayed reaction this time as the day of and the day after I received the spray I did not have any worrisome side effects. It occurred to me that these side effects are very similar to mild concussion symptoms which is, by definition, a mild traumatic brain injury. My head absolutely did NOT feel right. 5 days later I still have dizziness.

In my consent form it says: "In animal studies, at doses higher than those to be used in planned clinical studies of esketamine, DEATH OF BRAIN CELLS has been reported. The significance of these findings in humans is unknown."

Since this is a clinical trial - and the long-term effects are definitely not known right now - my fear is that this drug could be altering or damaging my brain. The problem is, it has helped my depression. I was borderline suicidal and within 2 weeks (4 treatments) that feeling was gone so it could literally be a life-saver for me. I don't want to stop but I am quite worried about being a guinea pig for a drug that has the potential to cause brain cell death.

Has anyone else experienced this or similar? Any and all feedback related to esketamine treatment is appreciated.


(Mod - I hope this thread is in the right place.)
 
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I think they are referring to Olney's lesions, they really shouldn't be a problem at those doses, matter of fact I'm not even sure if they've ever been observed in humans. Ketamine is extremely safe. Do you want me to move this thread to a more appropriate section?
 
There was a comedin show/movie all about every psych in one month and for ketamine he went to the docs, they plugged him up as soon as he injected it he was tripping with headphones on and a blindfold with a doctor next to him for saftey or to calm him down if he needs to be. I heard ketamine is safe, but the sessions in New York are about 3 grand for 6 sessions! Really sucks being that I’m on a AP that blocks lsd shrooms mdma stims and more and since I knew I can do ketamine I was stoked. But yea.. it’s safe from what I’ve heard, however, I’m not a doctor!
 
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