This trial is evaluating whether Miricorilant will improve 2 primary outcomes and 3 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of Up to Follow-up Visit (up to Week 16).
This trial requires 70 total participants across 2 different treatment groups
This trial involves 2 different treatments. Miricorilant is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
Data from a recent study adds to our growing knowledge of the common treatments used to manage schizophrenia. It also introduces a new area which requires more investigation: the use of the pharmaceutical industry for schizophrenia treatment.
The signs of schizophrenia consist of changes in perceptions, thoughts or mood. These may include experiencing mental slowness, changing the way people spend their free time, seeing people in the distance, or difficulty organizing conversations. There are also signs that involve a lack of motivation. These can include difficulties making choices, not finding the motivation to undertake an activity, and not having the energy to do jobs that require concentration. There are also signs of thinking problems, such as difficulty making judgments, having problems staying on task, poor reasoning, and problems remembering.
Schizophrenia and psychosis are two different conditions, though both have psychotic symptoms in common. Schizophrenia is a long-term mental illness that frequently resolves on its own, whereas psychosis is a chronic mental illness that can progress from one episode to another. The term 'psychosis' is often used to refer to either condition and thus can lead to misunderstanding. Schizophrenia is a neurological disorder that can affect brain functioning in many different ways. It can affect the thinking, behaviour, emotions and perception of the person diagnosed as schizophrenia. Schizophrenia, like bipolar disorder, may have an inherited component. It is believed to occur because of environmental factors or a combination between the environmental factors and an inherited vulnerability.
Treatment for schizophrenia should take into account the high propensity for psychosis to respond to medication, so that there are potential benefits for the patient.
Different factors may influence schizophrenia, including genetic and environmental factors. It is not clear what particular cause drives schizophrenia, however it is possible that both genetic factors and environmental causes are involved.
At least 180,000 Americans per year have schizophrenia. In the United States adolescents with a diagnosis of an affective disorder are 4.9% and 2.8% of those with a psychotic disorder. In a meta-analysis of 16 cohort studies in the US, the pooled prevalence of psychotic disorders in the general population was 5.3%. The incidence rate of psychotic disorders in the general population in the US is estimated at 1.6 new cases per thousand person-years. In a study of American adults the prevalence of psychotic disorders in the general population was 4.9%. In a cohort of elderly Americans study the lifetime prevalence of major depression was 28.8% with a lifetime prevalence rate of 1.
Miricorrant therapy using a selective DA D2 antagonist over 12 weeks in adults with stable schizophrenia is a safe and effective treatment that appears to reduce cognitive deficits in patients with schizophrenia. Miricorrant therapy significantly improved patients' QoL and may be an appropriate adjunctive therapy for those patients who do not respond to typical antipsychotic drugs and who have a poor QoL.
I think the average has to be higher than I've said for multiple reasons, it's not the same all over the world, and I think it just starts to decline at around 40-50 years old because there are more options of treatment and they have more control over their medication. I prefer to refer to this age range as having to be diagnosed with schizophrenia.
Miricorilant showed promise in reducing aggression in a short-term study in persons with schizophrenia, regardless of prior medication. More rigorous studies that investigate the long-term efficacy and side effects of miricorilant are warranted.
Although there have also been 3 randomized studies in adults and 4 retrospective studies in children, no randomized clinical trial has been performed. Further, a systematic review of all trials (published and unpublished) suggests that there is only poor evidence of efficacy, based on limited available data. This article is protected by copyright: all rights reserved.
Miricorlistimetic actions in humans may be mediated, at least in part, by the activation of the RhoA-Rho-kinase signaling pathway. The mechanism for this action may be mediated via the inhibition of the release of glutamate from synaptic vesicles.
Patients and their doctors are concerned around the possibility that clinicians are receiving grants and payment for conducting trials. Patients and their doctors also wish to have the most evidence-informed decision made possible. The issue of receiving payment at the trial stage and for conducting the trials themselves does not seem to be of great concern to these patients and their doctors.