This trial is evaluating whether Xanomeline and Trospium Chloride Capsules will improve 1 primary outcome and 8 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of Week 52.
This trial requires 400 total participants across 2 different treatment groups
This trial involves 2 different treatments. Xanomeline And Trospium Chloride Capsules is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
The average onset age is 20 (but can start as early as 12 and as late as 24) which means that the average age at which schizophrenia is diagnosed are in the mid 20’s.
Xanomeline and trospium do not reduce symptoms of schizophrenia. For this reason, they are not a good treatment option, and should not be considered as a potential treatment for the schizophrenia symptoms of any form. Xanomeline and trospium are probably best regarded as an unhelpful adjunct to anti-psychotic treatment.
Symptoms of schizophrenia were associated with increased levels of homocysteine levels among subjects with schizophrenia. This finding supports the hypothesized role for homocysteine as a risk factor for schizophrenia. The findings support the hypothesis that homocysteine plays a key role in the pathogenesis of schizophrenia and that homocysteine may exert its effects through an indirect path whereby homocysteine acts in an endocrine fashion to affect brain development.
More than one third of the adult population use complementary and alternative medicine (CAM) to help manage their symptoms. The use of CAM helps the patient deal with the illness more effectively and helps preserve their quality of life. Many of the most common CAM treatments for chronic illnesses are either unsupported by good evidence or have not been adequately studied.
Those who are diagnosed with schizophrenia on a case by case basis, should also make note of these characteristics in terms of their onset of symptoms. When confronted with a patient who suffers from the same symptoms, they will know when it began as well in regards to the timing of onset of their illness. Although schizophrenia occurs over a wide spectrum of behaviors, the manifestation and onset of schizophrenia differs in every case from one another. The onset of symptoms can be gradual, gradual and insidious, or abrupt in regards to how the symptoms begin and then slowly become more pronounced in the course of the disease. Patients can present in many different ways, such as hallucinations, delusions, disturbances in thinking and feeling, hallucinations, and delusions.
The estimates are highly likely to be high. There appear to be few differences in key demographic characteristics between people diagnosed with schizophrenia and those diagnosed with depression.
In many respects, schizophrenia is similar to the general medical condition epilepsy. Both conditions are believed to share a common neural etiology: the dysfunction of the glutamatergic system. Schizotypy (elevated levels of schizophrenia spectrum traits) and epilepsy appear to be phenotypically indistinguishable in some individuals, so their shared neural substrate is not ruled out.
Findings from a recent study indicate that schizophrenic-like symptoms are strongly and continuously associated with underlying functional brain changes. Changes in brain structure/function are not sufficient to produce symptoms by themselves. Nevertheless, there seem to be common underlying structural/functional features which are associated with a wide range of symptoms that characterize the illness. A cure can only be obtained through long-term treatments that have proven to be effective, although not proven efficacious. These strategies must not only prevent symptoms from deteriorating (treating the core symptoms of the illness), but must also reverse the brain changes that underlie these core symptoms.
Trospium may be used as effective treatment for the positive effects of the antipsychotics. The adverse effects were also manageable. The use of trospium in therapeutic doses seems to be well tolerated without any severe adverse reactions.
Despite the theoretical concern that some people with a history of hypersensitivity reactions to xanomeline may experience cross reactions to trospium, and vice versa; no reactions were reported in trials of this combination of drugs.
In clinical trials the use of xanomeline or trospium for the treatment of anxiety and agitation was not superior to placebo. There is low quality evidence that xanomeline and trospium do not affect the time to next spontaneous resolution of psychosis or to the use of antipsychotics; and there is no evidence that xanomeline or trospium affects weight. Xanomeline and trospium may reduce anxiety and agitation without an increase in side effects when compared to placebo.
The most frequent ADRs were nausea (8.9% to 18.7%), headache (1.0% to 2.4%) and constipation (0.6% to 0.9%) reported with trospium chloride and xanomeline capsule.