President of MRA signed an agreement to implement the first projects within the competition for non-commercial research in psychiatry and neurology
The President of the Medical Research Agency has signed the first agreement in the framework of the call in the field of psychiatry and neurology for the implementation of non-commercial clinical traials with the Institute of Psychiatry and Neurology . 10 projects with a total value of over 87 million PLN have been recommended for funding.
The Medical Research Agency call supports the National Mental Health Program. This area has been a discriminated field for many years. At the same time, when we looked at the development of neurosurgery, the topic of mental health was neglected. We are now seeing very rapid technological development in medicine, but also increasing needs in this area. The funds allocated by the ABM for this purpose are an important step towards improving the situation of patients by increasing accessibility to modern diagnostics and treatment methods - emphasizes the president of the Medical Research Agency, Radosław Sierpiński.
The main objective of the ABM call is to develop new diagnostic and therapeutic procedures in the field of psychiatry and neurology as part of non-commercial clinical research. Co-financed projects may translate into the possibility of therapy or increased effectiveness of current methods of treatment in diseases which constitute a very important health and social problem - such as multiple sclerosis, bipolar affective disorder or dementia.
One of the beneficiaries of the call is the Institute of Psychiatry and Neurology, which is a leading scientific center in Poland specializing in the development and dissemination of new methods of diagnostics, treatment and rehabilitation of mental and neurological disorders. The Institute is the leader of two projects co-financed within the framework of the Agency's call, with a total amount of nearly PLN 20 million. The projects implemented by IPiN are dedicated to patients with secondary progressive forms of multiple sclerosis and bipolar disorder.
Treatment of patients with secondary progressive multiple sclerosis
The Institute of Psychiatry and Neurology will conduct a phase 2 study led by Professor Iwona Kurowska-Jastrzębska. The study will evaluate the safety and efficacy of cladribine administered subcutaneously in patients with progressive form of multiple sclerosis (SPMS), in whom no relapses have been observed for 2 years and who may or may not have active changes in magnetic resonance imaging of the brain. The effect of the project, if positive, will be to enable patients with SPMS, currently without treatment options, to be offered an effective therapy and relatively inexpensive compared to other therapies used to treat multiple sclerosis.
Multiple sclerosis is the most common chronic inflammatory-demyelinating disease of the central nervous system. It affects approximately 2.5 million people worldwide, including about 45 thousand in Poland. The vast majority of patients (~85%) have the early stage of the disease in the form of a projection-remission disease, in which neurological symptoms appear periodically and may subside. This form of the disease can be treated with one of several approved disease-modifying drugs.
Unfortunately, a few to several years after diagnosis, the projection-remission form usually progresses to secondary progressive multiple sclerosis (SPMS), in which disability continues to worsen. Currently, there are only three disease-modifying drugs available for patients with SPMS, but these drugs can only be used in patients with so-called active SPMS as confirmed by the presence of flares or active lesions on brain MRI. For this reason, about half of SPMS patients cannot be offered any causal treatment.
In Poland, only about 14% of SPMS patients have disease-modifying treatment. The current state of knowledge suggests that from the beginning of the disease in patients with multiple sclerosis there are two types of inflammation in the central nervous system mediated by an autoimmune process. Both types of inflammation occur simultaneously from the onset of the disease, but it is believed that type 2 begins to dominate over the first in the secondary progressive phase. In addition, current drugs for SPMS have proven efficacy exclusively or primarily for type 1 inflammation and are registered for patients with flares or active brain MRI lesions.
Cladribine has proven anti-inflammatory activity - significantly reducing the number of lesions enhancing after contrast administration and the frequency of flares in patients with this form of the disease. Because cladribine passes through the blood-brain barrier, it has been suggested that it may also act on type 2 inflammation. This is evidenced by the disappearance of oligoclonal proteins in the CSF of patients treated with cladribine.
An opportunity for patients with bipolar affective disorder
The second study, to be conducted by the Institute of Psychiatry and Neurology, aims to evaluate the efficacy and safety of low-dose aspirin in a population of patients with bipolar affective disorder.
Recently, there have been reports from three cross-sectional multi-year population-based studies in which patients using aspirin for cardiovascular disease prevention had a reduced incidence of affective episodes
and a more favorable course of bipolar affective disorder.
Bipolar affective disorder affects 2-3% of the population, is chronic and relapsing, and has a relapse risk of up to 100%. The disorder significantly reduces quality of life and is associated with an 8-12 year reduced life expectancy compared to the general population. Depressive episodes, which dominate the course of the disease and account for 70-81% of the disease duration, are the most disturbing in quality of life and impair socio-occupational functioning. They are also associated with an increased risk of suicide, which is up to 10-30 times higher than in the general population.
Currently available treatment, even when prescribed correctly and with satisfactory patient cooperation, is insufficiently effective in up to half of patients. Refractory depression is often diagnosed in this group of patients. For years there has been a search for more effective therapies, but for over two decades there has been no breakthrough in the treatment of bipolar disorder, and the mechanisms underlying the disease are still not fully understood.
As the Institute's Director Prof. Halina Sienkiewicz-Jarosz emphasizes, we hope that our research funded by the Medical Research Agency will be the beginning of further intensive work for the development of psychiatry and neurology. We hope that with time, the Institute will also be able to establish a Clinical Research Support Centre for broadly defined brain diseases.