Health gives the green light to esketamine, the first and only treatment against resistant major depression

• Potential new antidepressant treatment with rapid onset and no adverse effects

Major

affects approximately

and is the leading cause of

worldwide.

Of these people, about a third do not respond to currently available treatments.

The probability of obtaining a response to a first

is around

, for the remaining 40% there are other therapeutic lines, but

pharmacological lines.

Patients and professionals with therapy-

have been without news for years, but the landscape is changing.

A clear example is the approval of

, a

that has been shown to be very efficient for antidepressant-resistant depression.

The Ministry of Health has given

for

for

, the first and only treatment approved in Spain for treatment-resistant major depressive disorder.

Marketed as

by the Janssen Pharmaceutical Companies of Johnson & Johnson, nasal esketamine is indicated in

with a selective serotonin reuptake inhibitor

or a serotonin norepinephrine reuptake inhibitor

in patients who have not had responded to at least

in the current moderate to severe depressive episode.

This would be the definition of a major depressive disorder that could benefit from this molecule.

fast onset molecule

One of the main contributions of

is that its

, effective from the first 24 hours of its administration, which compares with the 5 to 8 weeks of onset of effect of

.

These properties, together with the combination of a

, make the new

a "

; a 'rare bird' that has not appeared for 50 years. It is a paradigm shift for that 20-30 % of patients who

pharmacological treatments or other contemplated therapies", considers

, head of the Psychiatry Service of the Vall d'Hebrón Hospital, in Barcelona.

And it is precisely the fact of not being able to quickly treat patients with

who do not respond to other

has traditionally been one of the 'workhorses' for this disease due to the

that it can lead to this therapeutic void.

Marina Díaz Marsá, president of the Madrid Psychiatric Society, points out that

:

than the rest of the population.

"Having a fast-acting treatment will reduce the chances of

, as well as the

and

symptoms of the disease, a fact that occurs in one in four patients. A treatment that offers fast relief

by of the patient".

Despite the fact that in

there are still no

that guide the clinician to quickly recognize who may be susceptible to therapeutic resistance, Díaz Marsá explains that the

is one who presents severe major depression, middle-aged, who has required hospitalization in some of the depressive episodes, who manifests high anxiety and who has residual symptoms between episodes.

"

with

will not respond to previous treatments. Thus, intranasal esketamine, together with the pharmacological combination proposed in the indication, is a way of returning light to the eyes of these patients."

Glutamatergic system and responses

Esketamine

is a glutamatergic N-methyl-D-aspartate receptor antagonist that has a

, which means that it acts differently from currently available therapies for depression.

It restores synaptic connections between brain cells, allowing for increased activity and communication between

.

Based on the results of

, this increase in activity and communication is thought to lead to an improvement in

.

The

, such as serotonin, dopamine, norepinephrine and more recently

, among others, suppose a biological vulnerability.

With the introduction of this molecule, it acts on the

, increasing it indirectly, which gives rise to its effectiveness.

In fact, and according to the clinical studies carried out, "about

and get their symptoms to subside," says Ramos-Quiroga.

In his opinion, we refer to

that

previous treatments.

This therapy is going to change the way of acting with patients who require an

of approximately

Now,

we can reduce hospital stays, with what this entails for their quality of life and savings for the health system," says this psychiatrist.

The approval of

is based on data from a clinical trial program in people with treatment-resistant depression that has included more than

including Spanish patients.

The

included three short-term studies, one randomized relapse prevention study, and one long-term safety study.

Data have shown that

plus a new-onset

was associated with a greater reduction in depressive symptoms compared with a new-onset oral antidepressant plus placebo nasal spray in

(between 18 and 64 years), being effective from the first 24 hours.

hospital control

Approximately

treated with

responded to treatment, with a

.

The same trials show that continued treatment with

in combination with an oral antidepressant reduced the

among patients who achieved a

in patients who achieved remission .

stable, compared with continued oral antidepressant treatment combined with placebo nasal spray.

Professionals consider that the

represents great potential for the treatment of diseases of the central nervous system due to its

, potential

and

.

In this case, esketamine is designed for self-administration, such as those used for rhinitis, under the

.

"Its effectiveness occurs after the first 24 hours, reducing depressive symptoms on day 28 and the risk of relapse, and with a favorable tolerability profile," the studies indicate.

Regarding its health administration, Ramos Quiroga explains that it is because one of the adverse effects can be "

, and this control by health professionals allows adequate intervention if necessary."

Víctor Pérez Sola, president of the Spanish Society of Psychiatry and Mental Health (SEPSM) has shown that, at this time,

of full clinical utility to know if a patient is going to be resistant to various therapeutic lines, beyond of the

aforementioned

For this reason, he considers that

is an essential necessity so that "translational studies, from the

, be fast, a fact that in Psychiatry costs more work than in other specialties", a point that he shares with Ramos-Quiroga , who has anticipated that research is already being done on

in this type of non-responder patients, as well as on the usefulness of intranasal esketamine in the

.

go up in the same elevator

Díaz Marsá, recalled that major depression

, the year in which 53 million depressive disorders were registered, with young people and women being the most affected groups.

"Major depressive disorder is usually

of patients,

, lasts 2 years or more,) in

of those affected, which usually leads to a substantial deterioration in the ability to of people to perform adequate functional activity.

For Pérez Sola, the

of mental illnesses still limits diagnoses and treatments, which highlights the need to invest more in mental health.

It is also necessary to take into account the

that accompanies this type of disease, both for the patient and their families, and with repercussions in the health field.

"It is necessary that patients with mental health disorders

.

Conforms to The Trust Project criteria

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