Updated Monday, March 11, 2024-18:15

This trial, led by Boehringer Ingelheim and carried out in several hospital centers, investigates the effectiveness of a drug(*) intended to improve the cognitive deterioration associated with schizophrenia.

To improve their treatment, the active collaboration of patients in clinical trials is needed.

Schizophrenia is a complex and chronic mental disorder suffered by 0.37% of the Spanish population (4.5% are men and 2.9% are women) (**).

It causes serious alterations in the person's thinking, perception of reality and behavior.

It can cause hallucinations, delusions and profound personality transformations.

All of this has an impact on daily functioning and can be disabling.

This pathology, considered the prototype of serious psychiatric disorders, usually begins between adolescence and 35 years of age, and is usually more serious the earlier it manifests.

"Schizophrenia affects 1 in every 100 people, regardless of gender, although the onset is earlier in men (between 15 and 25 years) than in women (25 and 35 years)" says

Rosario de Arce

, psychiatrist and head of Service at the Puerta de Hierro Hospital in Madrid, and professor at the Faculty of Autonomous Medicine of Madrid.

Rosario de Arce, psychiatrist and head of the Service at the Puerta de Hierro Hospital, Madrid.

Positive symptoms, such as hallucinations or delusions, are the best known.

"These hallucinations are usually auditory, with voices that order them or speak about them in the 3rd person, delusional ideas or intuitions that "something serious is happening," explains the expert. They also suffer negative manifestations, the so-called picture of cognitive and affective deterioration. (flattening, emotional indifference, apathy and social isolation).

Impairment in cognitive functions

A high percentage of patients with schizophrenia present a certain degree of cognitive impairment associated with this mental illness and this has a significant impact on their lives, as well as that of their caregivers and family members.

Not surprisingly, approximately 85% (**) of people living with schizophrenia will experience some level of cognitive impairment.

In this regard,

Dr. de Arce

warns us that this deterioration is the core of the disease and has an important cognitive component that will determine day-to-day, family, social and occupational dysfunctions." These symptoms, difficult to detect, they are usually among the first to develop, even before positive manifestations and can already cause problems with memory, attention, thinking speed and concentration, significantly impacting their lives.

"Overcoming the challenge presented by this cognitive impairment associated with schizophrenia could allow people living with schizophrenia to live more autonomous and productive lives."

The specialist makes a classification of schizophrenic deterioration in the global functions affected by the disease.

In the

cognitive area,

a deficit is observed in functions such as planning activities, a decrease in intellectual abilities, attention and memory.

"Patients with schizophrenia have poorer results than the general population in performing cognitive tests."

In the

emotional area

, indifference appears, making the patient lonely, distant and cold.

Once a firm diagnosis has been established, Dr. Rosario de Arce comments that her treatment is long-term, in many cases for life.

There is currently no marketed treatment for the cognitive impairment associated with schizophrenia and those that exist today do not improve this symptom.

CONNEX Study

Cognitive impairment cannot be addressed with current antipsychotics, so treatments and solutions are needed that offer effective symptom control.

Boehringer Ingelheim has launched the

CONNEX study, a clinical trial that is being carried out in different hospitals in Spain to test the effectiveness of a drug for the treatment of symptoms such as cognitive impairment

.

The drug, which has already passed phase II, has been shown to improve cognition in adult patients with schizophrenia.

It is currently in an advanced process in phase III (CONNEX STUDY).

Dr.

de Arce

points out the importance of the study since, "until now no drug has been approved for this indication."

Impact on quality of life

"The person with cognitive impairment has social isolation, revealing the profound transformations of the subject's emotional and relational world," says the psychiatrist.

This indifference causes

isolation, both within the family and socially, in the patient

, along with a lack of emotionally experienced stimuli and a neglect of habits and personal hygiene.

"

Working life does not usually exist

, you do not usually have a job and when you find one there is a risk of losing it."

The cognitive impairment associated with schizophrenia

has a significant impact on those affected, as well as their families and caregivers

.

"The family needs information, support, availability and advice. Families should also rely on associations that offer psychological support, legal advice, talks and courses with different professionals," says the psychiatrist.

Early detection

Among the main challenges in managing this pathology is

early detection.

Dr.

Rosario de Arce

assures that

the shorter the duration of untreated psychosis, the better response, better recovery and less deterioration is observed

.

"In some studies,

50% of patients take up to two years to go to specialized care for the first time

, which is why it is essential to carry out a screening program in primary care," she comments.

Other pending challenges are

ongoing disease management and long-term support

.

Pharmacological research must go towards the search for new molecules, since they can reverse or reduce functional damage.

"We have drugs for positive symptoms, not negative ones."

Therefore, the importance of clinical trials and studies such as CONNEX that help evaluate new treatments for the cognitive impairment associated with schizophrenia.

+This clinical trial is in the patient recruitment phase at the Puerta de Hierro Hospital in Madrid, with Rosario de Arce, as psychiatrist and researcher.

Reference

(*) Medication in the investigational phase.

It has no authorized indication.

(**) Study 'Mental health in data: prevalence of health problems and consumption of psychoactive and related drugs from primary care clinical records', from the Ministry of Health2.

Available at: https://www.sanidad.gob.es/estadEstudios/estadisticas/estadisticas/estMinisterio/SIAP/Salud_mental_datos.pdf

(***) OECD (2021), Health at a Glance 2021: OECD Indicators, OECD Publishing, Paris, https://doi.org/10.1787/ae3016b9-en.

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