Ketamine against depression
In the USA, an esketamine-based antidepressant was approved, but in a very limited mode
Evgenia Shcherbina, "The Attic"
On March 5, the American Food and Drug Administration (FDA) approved the use of a nasal spray "Spravato" based on a variety of ketamine. It is intended for the treatment of major depressive disorder, which other antidepressants cannot cope with.
Esketamine is a form of ketamine, a substance that is used as a means for anesthesia or, less often, an analgesic. Ketamine and similar substances are more often used by veterinarians, because in humans they can cause dissociation – a violation of the normal functioning of consciousness. For this reason, ketamine has become popular with fans of psychoactive substances.
Nevertheless, in strictly defined doses, in the form of a nasal spray, esketamine proved to be an effective remedy for depression. Its effect is based on the fact that it helps to restore synaptic connections in the brain disrupted by depression.
As follows from the press release of the FDA, the effectiveness of "Spravato" was tested in three short (within a month) clinical trials, in which 1,273 people aged 18 to 64 years participated, and one long-term safety study (for six weeks), in which 137 people over 65 years participated. In short trials, patients received either "Spravato" or a placebo. At the same time, the patients were additionally given an oral antidepressant, since they were in severe depression.
The effectiveness of the new drug was tested by comparing how the patients' condition changed after the course of treatment "Coped" compared to the initial level of depression. After the first trial, the drug showed that it could alleviate the symptoms of depression compared to a placebo. The effect of it was noticeable after two days. The other two tests did not help to reliably assess whether "Coping" would help with depression.
The long-term study involved patients in stable remission or with a stable effect from antidepressants. The first group continued treatment "Coped" together with an oral antidepressant, the second – a placebo and an oral antidepressant. As a result, it turned out that in the first group, depressive symptoms became easier over a longer period than in the second. Therefore, the FDA decided to approve the treatment with esketamine, but with restrictions. American doctors will be able to use it in combination with oral antidepressants and only after at least two attempts to cure the patient with other drugs that did not have an effect.
It should be noted that "Spravato" has side effects. Due to abuse or improper administration, the drug can excessively calm the patient. He may have impaired thinking and attention, as well as thoughts of suicide. In addition, during the trials, patients experienced side effects such as dizziness, nausea, decreased sensitivity, anxiety, increased blood pressure, vomiting and a feeling of intoxication.
"Patients with unstable or poorly controlled elevated blood pressure or pre-existing aneurysmal (associated with local dilation) vascular disorders may be more likely to have adverse cardiovascular or cerebrovascular effects," the release says.
Therefore, the FDA decided to limit the use of "Spravato": it will be possible to take it only in the presence and under the supervision of a doctor and only in the clinic. It is forbidden to buy the drug or take it home. Also, the manufacturer of the drug, Johnson & Johnson, will have to warn about its side effects and the risks of abuse on the label. According to the Management's prescription, after taking a dose, the patient should be under the supervision of a doctor for at least two hours, and he will assess his condition and decide when it will be possible to leave. In addition, until the end of the day, the undergoing treatment "Spravato" will not be allowed to drive a car.
Excetamine is approved as a medicine for the first time in history. Earlier, in 1970, the FDA had already approved a ketamine–based drug, Ketalar.
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