For the first time in 30 years, the depressed people who do not respond to therapies, 300,000 in Italy and 100 million worldwide, according to the WHO, have a treatment that can act more quickly and effectively than standard therapies and that could reduce the suicidal ideations. In fact, one of the main problems related to the pharmacological treatment of major depression is the long interval of time that elapses before the improvement of depressive symptoms, which can be fatal. The new drug, unlike the others, acts on an innovative mechanism that arises rapidly and persists even after the end of the treatment.
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The first study
To say this are the experts of the Italian Society of Psychiatry (SIP), gathered in Genoa for the national congress, in light of the very encouraging clinical results of the first Italian study on esketamine, a derivative of ketamine, used since the 1970s in all hospitals as an anesthetic and used in veterinary medicine. However, it is also a hallucinogen, banned almost everywhere, because it is considered amazing.
“The results of our study, which is added to the studies and clinical experiences that accompanied the approval dossier also by Aifa last April, – declare Massimo di Giannantonioauthor of the research and co-president of Sip together with Enrico Zanalda – show that ketamine can solve very serious cases of depression of many patients who do not respond to treatment, with suicide attempts behind them.
The new molecule anticipates the effectiveness of traditional therapies by fifteen days, which take several weeks before giving results. Symptoms improve from the first hours with more powerful and persistent effects than standard therapies and are well tolerated. But – experts warn – it is a territorial H-drug for hospital use, that is used only in the territorial clinics of the Mental Health Departments, to be used under strict medical supervision and reserved only for forms of depression resistant to treatment and at risk of suicide”.
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On which patients it is good to use it
According to the clinical results of the first Italian study on Esketamina, published in the Journal of Affective Disordersthe drug is safer and faster and more effective in treating treatment-resistant depression, even in patients with personality disorders or addicted to substances.
The research coordinated by the G. D’Annunzio University of Chieti and the University of Brescia involved 22 other centers scattered throughout Italy for a total of 116 patients, treated with the new drug in the form of a nasal spray. The results show that, thanks to the new drug, over 64% of patients benefit from a significant improvement. Of these, 40% had a complete remission of the disease. “The first symptoms already improve within the first 24 hours from a single dose, with very important results after fifteen days which, one month after treatment, increase even more and after two months lead to complete remission of the disease. almost half of the patients “, underline di Giannantonio and Zanalda.
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Remember hallucinogens
At the same time, the researchers observed no unexpected security problems. “Esketamine is a mirror molecule of ketamine, an old anesthetic also used as a hallucinogen that acts in a completely different way from ‘classic’ antidepressants, which affect the levels of serotonin, the neurotransmitter called ‘good mood hormone’ – explains di Giannantonio – The new molecule, on the other hand, acts on the glutamate receptor to help restore the connection between synapses in brain cells. “
Last April, after the FDA and EMA, Aifa also authorized its use in patients with depression with failure to respond to at least two drugs at an appropriate dosage and duration.
“The effect of Eskatamine lasts over time and is well tolerated – the experts underline -. The drug – they add – can have transient dissociative or hypertensive effects but does not cause cognitive consequences such as a reduction in working memory or speed of thought. Yes. it is therefore an important opportunity for patients with resistant depression but should be used under medical supervision by keeping patients under observation for about an hour after administration “.
It will take time for everyone to prescribe it
“This is a great step forward for the treatment of depressive diseases – say of Giannantonio and Zanalda – but further clinical studies will be needed for this therapeutic innovation to become a tool in the hands of all Italian psychiatry. However, these very promising results seem to allow an opening of credit also towards other psychedelic substances, such as psilocybin, the active principle of some hallucinogenic mushrooms but not as powerful as LSD. This gives hope that, in the future, other substances to be studied and perhaps also for use in clinical practice “.