Pregnenolone 800 mg for Psychosis, Involutional
This study is evaluating whether pregnenolone may have positive impacts for individuals with major depressive disorder.
See full descriptionAbout the trial for Psychosis, Involutional
Treatment Groups
This trial involves 6 different treatments. Pregnenolone 800 Mg is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Pregnenolone 800 mg will improve 5 primary outcomes in patients with Psychosis, Involutional. Measurement will happen over the course of 7 days.
Who is running the study
Principal InvestigatorPatient Q & A Section
What is pregnenolone 800 mg?
Pregnenolone 800 mg seemed to show a satisfactory antidepressant effect among patients with psychotic symptoms. Future studies should focus on long-term antidepressant drug effects, possible side-effects, and drug tolerance.
What is psychosis, involutional?
The definition and criteria of psychosis as well as the term involutional can be confusing. Clinicians who understand the term psychosis need to know that not everyone who thinks they do have a psychotic disorder will have clear symptoms and objective observations. Rather, these 'clinicians' use their training and experience to determine the nature of the patient's problem. Psychiatrists have training to make this assessment. Therefore, 'clinicians' should be able to assess a diagnosis using some combination of objective observations, interviewing, laboratory tests, mood and cognitive testing, and an assessment of the patient's beliefs and attitudes to diagnose the patient appropriately and accurately. The 'clinician' will consider a number of signs and symptoms that are considered to support a diagnosis.
What are the signs of psychosis, involutional?
Patients should be monitored carefully to see if they are in deterioration for schizophrenia, and also because of the risk of psychosis and involutional changes in bipolar. Psychiatric drugs should be stopped and the dose of antipsychotic drug reduced if necessary, and in cases of psychosis, antipsychotic atypicals should also be stopped.
What are common treatments for psychosis, involutional?
Common treatments for psychosis include antipsychotic medications, behavioural therapies and drug therapy. Most schizophrenic and psychotic patients will undergo a course of treatment of anywhere from six weeks as a treatment protocol to five to eighteen months. Furthermore, involutional psychosis and the ensuing post-involutional psychosis are treated with antipsychotic drugs along with mood stabilizers.\n
How many people get psychosis, involutional a year in the United States?
How many elderly people live in the United States yearly with major psychotic complaints and/or symptoms such as delusions, hallucinations, depressed mood, and/or disorganized speech? An estimated 15 million of them might receive adequate treatment. If treated, their life expectancy might be significantly prolonged.
Can psychosis, involutional be cured?
Involutional psychosis may resolve in some cases in which it appears in early life, often without antipsychotic treatment or a previous history of psychosis. Involutional psychosis may resolve without or without antipsychotic treatment.
What causes psychosis, involutional?
The causes of psychosis are unknown. There is evidence at least for psychosis to have an genetic predisposition as well as a significant impact on brain development in the first year of life and also some evidence for an age predisposition when some psychiatric disorders tend to increase with age (inversely to an onset earlier in life).
Does psychosis, involutional run in families?
Recent findings refute the hypothesis that there is a specific familial aggregation for schizophrenia and psychotic disorders, but it is possible that it could be related to genetic mutations that have not yet been identified in non-affected relatives of patients.
Has pregnenolone 800 mg proven to be more effective than a placebo?
In a recent study, findings indicate that the treatment with P 800 mg led to more subjective and objective positive effects in comparison with a placebo, in addition to the better tolerance and less gastrointestinal side effects.
What is the primary cause of psychosis, involutional?
[Inevitable causes of psychosis, involutional include both infectious and non-infectious conditions. Infections like Chagas, syphilis and gonorrhea are among them.] Involving [autoimmunity] and [inflammation] are both among the most common causes of primary psychosis, involutional.
Have there been any new discoveries for treating psychosis, involutional?
The recent findings do not contribute to our understanding of the pathogenesis of psychosis. The only thing that we can conclude from these findings is that they should encourage the next generation of schizophrenia researchers to be mindful of the possibility that the treatment of psychosis remains elusive for this disease.
What are the latest developments in pregnenolone 800 mg for therapeutic use?
Pregnenolone 80 mg was well tolerated in a short term open labeled, parallel group, dose escalation study. It was not associated with significant increase in psychotic symptoms or increase in depression, unlike other Pregnenolone products that have been used in clinical studies for more than a decade. Furthermore, PK/PD modeling suggests that a steady state is reached in less than 4 weeks. Oral Pregnenolone 80 mg can safely and quickly be dosed for use in the peri-impotence and perimenopausal setting and in the elderly for short-term treatment.