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.
"Schizophrenia is a chronic mental illness in which a person has a disturbed mental function for at least two weeks and that disturbs his or her day to day life. It is a schizophrenia psychosis. A psychosis is a mental disorder in a psychotic schizophrenic. Schizophrenia is divided into psychotic and affective states. It is the psychotic state that most people in prison will experience as a symptom. It is an extremely disabling condition in which all patients seem to suffer from some degree of depression-like symptoms. The disease is characterized by recurrent episodes of psychosis which vary in symptoms ranging from mild to severe psychosis. It is a very serious mental disorder and can bring with it many serious psychological effects." - Anonymous Online Contributor
"It is likely that schizophrenia is the result of an underlying susceptibility combined with a multiplicity of environmental risk factors. The environmental risk factors may be genetic or environmental and may change and become more complicated with time, so a single factor perspective is likely to conceal a complexity. The role of social and behavioural factors may be particularly under-addressed." - Anonymous Online Contributor
"About 5.4 million children in the United States are currently diagnosed with ADHD. Around 5 to 6 million people are diagnosed with schizophrenia annually in the Unites States." - Anonymous Online Contributor
"Nearly two-thirds of the patients surveyed used various antipsychotic medications, mostly at lower-than-therapeutic dose. Medications to treat other conditions are also prevalent, especially in female cases. The use of antidepressants is not uncommon, though is less likely to be prescribed for the treatment of schizophrenia than in the general population. About one-third of the cases reported that they saw a psychiatrist and about one-half indicated that they had been diagnosed with depression. Only 15.1% of patients self-reported that they had been diagnosed with schizophrenia and not treated." - Anonymous Online Contributor
"Hallucinations and delusions are typical neurological symptoms in people with schizophrenia. Other more subtle signs include behavioural changes such as lack of motivation, changing sleep patterns, depression and trouble thinking. These symptoms can begin around the age of 25 years and, in many instances, are not evidently visible in people without schizophrenia. Patients with schizophrenia often report experiencing symptoms such as excessive talking or poor concentration for some as long as 25 years. If one is wondering what the sudden change in a patient is then look for signs of schizophrenia in their family history." - Anonymous Online Contributor
"The possibility exists that with more effective treatment, psychotic symptoms can be eliminated. However, such treatment will never stop all symptom or the underlying deterioration of the brain." - Anonymous Online Contributor
"This placebo-controlled, double-blind, randomized, parallel group study suggests that bi 425809 at either 0.25 or 0.5 mg/kg does not improve the QoL of people with schizophrenia" - Anonymous Online Contributor
"Familial risk of a first episode of schizophrenia is weak. In a number of case-control studies, some subjects with a first episode of schizophrenia show evidence of a genetic relationship to their relatives. The majority of these studies have been limited by small sample size. We have shown that in a large population based sample, such clustering is not strongly associated with schizophrenia." - Anonymous Online Contributor
"Recent publications have outlined some of the most important discoveries in schizophrenia research: that it is a spectrum/continuum, that it is on a biological model, that there are important biological mechanisms for brain development abnormalities in schizophrenia. There is also new work suggesting that schizophrenia is a disconnection syndrome, that it is influenced by both genetics and the environment, and that it may be genetically heterogenous. There have also been studies which support earlier findings that schizophrenia is associated with significant delays in brain growth. There are many new discoveries happening and a small but growing body of evidence that should be added to the growing literature in this area as they emerge." - Anonymous Online Contributor
"When used at lower doses, BBKG appears to have better retention rates on cognitive and behavioural measures than the benzodiazepine bi 425809. Both drugs have similar efficacy in reducing psychotic symptoms." - Anonymous Online Contributor
"The present findings support the psychopharmakologic model of schizophrenia as an explanation for its causation. The importance of the early diagnosis of autism spectrum disorders remains." - Anonymous Online Contributor
"The present study suggested that treatment of a clinical trial of BDNF in the prefrontal cortex, where the primary site of action is thought to be, was associated with improvements in a relatively wide range of symptom dimensions in patients with psychosis. ClinicalTrials.gov identifier: (NCT00391278)." - Anonymous Online Contributor