CLINICAL TRIAL

Pregnenolone 800 mg for Psychosis, Involutional

Recruiting · 18+ · Female · Dallas, TX

This study is evaluating whether pregnenolone may have positive impacts for individuals with major depressive disorder.

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About the trial for Psychosis, Involutional

Eligible Conditions
Major Depressive Disorder (MDD) · Depression · Depressive Disorder, Major · Depressive Disorder

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.

Experimental Group 1
Pregnenolone 500 mg
DRUG
+
Pregnenolone 800 mg
DRUG
+
Placebo
DRUG
Experimental Group 2
Pregnenolone 500 mg
DRUG
+
Pregnenolone 800 mg
DRUG
+
Placebo
DRUG
Experimental Group 3
Pregnenolone 500 mg
DRUG
+
Pregnenolone 800 mg
DRUG
+
Placebo
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Eligibility

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Women, ages 18-65 years, with current MDD (mild or moderate severity per DSM-5) based on SCID-CV.
No psychotropic medications, other than PRN (as needed) hypnotics, within 28 days of randomization (medication free).
PRN hypnotics allowed up to 3 days prior to study drug administrations but not while receiving study drug.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 7 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 7 days.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Pregnenolone dose.
7 DAYS
Identify a dose of pregnenolone that demonstrates bioavailabilit and tolerability.
7 DAYS
Serum pregnenolone level.
7 DAYS
Measure blood serum pregnenolone and allopregnanolone levels.
7 DAYS
GABA concentration.
7 DAYS
Occipital GABA concentration using spectroscopy.
7 DAYS
Systematic Assessment for Treatment Emergent Events (SAFTEE).
7 DAYS
SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). The higher total score (all items summed together) indicates a higher level of side effect burden.
7 DAYS
Functional connectivity.
7 DAYS
Amygdala-PCC or dlPFC-insula functional connectivity using structural neuroimaging.
7 DAYS

Who is running the study

Principal Investigator
S. B.
Prof. Sherwood Brown,, MD PhD
University of Texas Southwestern Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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