This trial is evaluating whether BI 425809 will improve 1 primary outcome and 4 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of up to 24 weeks.
This trial requires 586 total participants across 2 different treatment groups
This trial involves 2 different treatments. BI 425809 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 3 and have had some early promising results.
"The study confirms the previous results on the high remission rate and relapse incidence in the first year after discharge. In addition, the remission rate and relapse rate increased in the following years." - Anonymous Online Contributor
"The most common treatments are over-the-counter oral medication, such as antipsychotic drugs, and medications made to correct abnormal hormone levels, such as gonadotropin-releasing hormone agonist.\n\nThe term medication refers to pharmaceutical products used to treat diseases. Types and dosages of the products that fall under this category vary depending on context. Depending on the country, type of disease state the patient is involved with, and their need for the product, the price of the product is also important." - Anonymous Online Contributor
"The percentage of people who get SCZ in a given year is 0.5 per 10,000 in the United States. This is similar to the estimate for Western Europe and Australia. Since schizophrenia has a duration of up to three years, an estimated 2.4 million people a year in the United States could have the diagnosis and experience significant clinical consequences. Further studies are needed to define the full geographic, social, and cultural factors that determine incidence of SCZ/SZ, as well as the natural course, duration, and clinical outcome of SCZ/SZ for all ethnic and socioeconomic groups." - Anonymous Online Contributor
"It is concluded that the symptoms of schizophrenia are similar to the symptoms of other psychosis. However, the diagnosis depends on the patient's history, the clinical picture, and the neurological examination." - Anonymous Online Contributor
"Schizophrenia is a mental disorder that is marked by symptoms of disorganized speech or thought, reduced social functioning, and marked by blunted responses in at least one non-negative symptom category. Approximately 1 in 70 individuals will have schizophrenia at some point in their life." - Anonymous Online Contributor
"These data are consistent with a major role for psychosis in a major genetic risk. This risk appears to be strongly influenced by environmental factors. Schizophrenia is a complex disorder that is poorly understood at a genetic and molecular level with the potential for new therapeutic targets being identified." - Anonymous Online Contributor
"Bi 425809 is superior to a placebos in reducing tardive dyskinesia, as assessed within the first year after treatment at up to a week earlier than for the placebo. Furthermore, a greater decrease in dyskinesia was found in the Bi 425809 group in this study compared to the placebo group. Results from a recent paper must be confirmed by others, but this is compelling support for use of Bi 425809. Furthermore, the findings also support the use of Bi 425809 for tardive dyskinesia, irrespective of concomitant use of antipsychotics other than haloperidol." - Anonymous Online Contributor
"There have been some important new developments that may pave the way for new treatments. These include the use of olanzapine in combination with clozapine and the use of varenicline as a potential treatment for schizophrenia is discussed, although further research is needed in larger patient samples." - Anonymous Online Contributor
"Bi 425809 does not cause a clinically meaningful increase in QT interval and is unlikely to cause a clinically meaningful prolongation of the QTc interval and may even be safe in some people with schizophrenia." - Anonymous Online Contributor
"The evidence of both genetic and environmental causes is highly compatible with the explanation that schizophrenia is the best example of a disease for which both genetic and environmental factors play a role in its etiology. A major implication of our findings is that individuals with severe symptoms often have less than optimal responses to a range of potential treatments that are usually employed in milder cases." - Anonymous Online Contributor
"Bi 425809 has the potential to generate a broad spectrum of common, albeit transient, adverse effects similar to those seen in other antidepressants and anxiolytics including sedation, headache, dizziness, insomnia, tremors, nausea, diarrhea, and fatigue. These side effects can generally be managed by adjusting dose or dosing interval to reduce the risk of development. Common side effects of bi 425809 that were not alleviated by dose adjustment or dose reduction include: dry mucous membrane, diarrhea, constipation, rash, pruritus, sweating and insomnia. Rare but serious adverse events include acute overdose, allergic reaction (i.e., anaphylaxis), and potentially fatal liver or heart attack." - Anonymous Online Contributor
"In a recent study, findings of this randomized double-blind trial do substantiate in vivo the earlier findings of a clinical study. Bi 425809, in the doses and intervals used, provided a rapid, significant decrease in symptoms of schizophrenia. The effects of Bi 425809 are mediated by dopamine D2 and dopamine D3 receptors. If it can be proved that Bi 425809 is efficacious in the treatment of schizophrenia, it should be considered for rapid-release drug trials at the doses and intervals used in this study." - Anonymous Online Contributor