Seltorexant for Psychosis, Involutional
This study is evaluating whether a drug may help improve depression symptoms in individuals who have not responded to other medications.
See full descriptionAbout the trial for Psychosis, Involutional
Treatment Groups
This trial involves 2 different treatments. Seltorexant 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.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Psychosis, Involutional or one of the other 2 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Seltorexant will improve 1 primary outcome and 9 secondary outcomes in patients with Psychosis, Involutional. Measurement will happen over the course of Baseline to Week 26.
Patient Q & A Section
What is psychosis, involutional?
Data from a recent study provides evidence that the psychopathology of psychosis or brain morphology in people with schizophrenia has to be integrated in order to understand the complexity of this disorder.
What are common treatments for psychosis, involutional?
Treatment for involutional psychosis is not well defined. The most common recommended treatment is olanzapine, a medication often used for schizophrenia. One limitation of this study is that the sample is not geographically representative, because participants had to take an online survey rather than being interviewed in-person about their experiences with the disease being studied. Another limitation is the small sample size. The small sample size and the study being retrospective have made finding statistically valid answers harder. However, the use of online questionnaires allows for a more representative sampling of opinions.
What causes psychosis, involutional?
Although psychosis can be induced in test animals with the'stress hormone' dexamethasone, it is difficult to demonstrate in test animals that psychosis is a 'psychosis'. We do not now possess the pharmacological techniques required to study psychosis with test animals. But we do know that it is related to brain-to-brain and CNS-to-cognitive (thinking) communication. In fact, the brain's dysfunction with schizophrenia may be the very root cause of the disease.
How many people get psychosis, involutional a year in the United States?
About 690,000 people develop psychosis in a year in the Unites States, and about 10,000 die from it. The death rate is higher in the South of the country. Psychosis occurring in people over 50 years old is strongly associated with physical conditions leading to death.
Can psychosis, involutional be cured?
The efficacy of risperidone treatment demonstrated that alleviation and reduction of psychotic symptoms could be achievable in patients with a psychiatric diagnosis of psychosis, involutional.
What are the signs of psychosis, involutional?
Results from a recent clinical trial confirm that the psychotic syndrome of psychosis, involutional is a different entity from that classically recognized as psychotic breakdown.
What is seltorexant?
Recent findings describes for the first time an unexpected phenomenon of increased body weight at baseline compared to controls in patients receiving seltorexant. Recent findings suggest that seltorexant-induced weight gain is unrelated to the inhibition of hunger in the acute phase, but may be due to increased energy expenditure due to an extended suppression of the circadian rhythm. Given this finding and the very short half-life of the drug, dose adjustments of seltorexant in patients with known decreased energy expenditure are unlikely.
Is seltorexant typically used in combination with any other treatments?
On average, seltorexant was co-used with 2.6 other different medications. Combining seltorexant with other agents with different mechanisms of action could theoretically result in undesirable drug interactions and side effects.
Is seltorexant safe for people?
Patients with mental illnesses take at least one medication and, at least in this study, people taking seltorexant for insomnia do not always appear to take multiple medications. There were no adverse events reported in this study with seltorexant; the drug was evaluated and found to have a high safety profile. No evidence of a significant interaction was noted. The lack of an obvious interaction, along with the high rate of discontinuation (12%) and the short duration of the trial in our patient population, indicates that further clinical evidence may be required to determine the safety of seltorexant for patients with such diagnoses.
Have there been other clinical trials involving seltorexant?
Given the potential for serious side effects, these findings do not suggest that physicians (and other scientists) should use seltorexant in their practice. However, the findings may be helpful in limiting clinical trials that could result in the prescription of seltorexant to patients when more safe and effective drugs are available.
How serious can psychosis, involutional be?
Even in the absence of symptoms related to dementia or other cognitive dysfunction, [in older adults it can have significant consequences, including reduced physical and cognitive functioning over time, in addition to being responsible for >30% of admissions to long-term care facilities in Japan] psychosis, involutional in individuals over 75 years of age can be a more serious issue for society.