CLINICAL TRIAL

Pregnenolone for Psychosis, Involutional

Recruiting · 18+ · Female · Dallas, TX

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

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About the trial for Psychosis, Involutional

Eligible Conditions
Major Depressive Disorder (MDD) · Depressive Disorder, Major · Depressive Disorder · Menopause · Perimenopause

Treatment Groups

This trial involves 4 different treatments. Pregnenolone is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Pregnenolone
DRUG
Experimental Group 2
Pregnenolone
DRUG
+
Placebo
DRUG
Control Group 3
Placebo
DRUG
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About The Treatment

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

Eligibility

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Women who have experienced changes in menstrual cycle frequency or duration, and/or physical symptoms indicative of menopausal transition, as determined by clinician
Women who are using hormonal IUDs (i.e. brands Mirena and Skyla), with FSH level > 20 mIU/m (as menstrual periods are irregular with IUDs that utilize hormones, making irregular/absent periods difficult to assess as related to the menopausal transition).
Greene Climacteric Scale total scores > 20
Greene Climacteric Scale sub-score for vasomotor symptoms >3
5 or more bothersome hot flashes per week (self-reported)
Baseline HRSD score of ≥ 18
Subject agrees to abstain from disallowed medications for the duration of the trial
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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: 16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 16 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 will improve 1 primary outcome, 6 secondary outcomes, and 4 other outcomes in patients with Psychosis, Involutional. Measurement will happen over the course of 16 weeks.

Columbia-Suicide Severity Rating Scale (C-SSRS)
16 WEEKS
safety and tolerability data-is anobserver-rated measure for assessing suicidal ideation and risk in clinical trials. C-SSRS consists of subscales assessing severity of ideation, intensity of ideation, suicidal behavioral, and lethality
Systematic Assessment for Treatment Emergent Events (SAFTEE)
16 WEEKS
safety and tolerability data- is an 56-item self-report checklist used to assess study drug side effects and tolerability
Cognitive and Physical Functioning Questionnaire (CPFQ)
16 WEEKS
safety and tolerability data-is an 7-item self-report questionnaire that assesses possible cognitive and physical side effects
Blood drawn
16 WEEKS
changes in neurosteroid levels-CBC,CMP, Neurosteroid levels
Rey Auditory Verbal Learning Test (RAVLT)
16 WEEKS
Assess changes in cognition: is an auditory assessment of verbal learning and memory, in which the participant is asked to recall a list of words first immediately following presentation (immediate recall) and later following a set period of time (delayed recall)
Pittsburgh Sleep Quality Index (PSQI)
16 WEEKS
Quality of life: (secondary outcome) is an 9-item self-report scale used to assess sleep quality and disturbances during the past week
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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 psychosis, involutional?

The clinical features of involutional psychosis (first episode) are similar to those for the first episode of schizophrenia (first episode): age < 40, absence of family history of psychotic disorders, absence of prodynin in first episode, and rapid recovery without overt psychotic symptoms.

Anonymous Patient Answer

What are common treatments for psychosis, involutional?

Recent findings are to a greater extent similar to those obtained for psychosis. The drugs that are most frequently used are as follows: antipsychotics and antidepressants, and the most common psychotropic medication type used in case of involuntary commitment is quetiapine.

Anonymous Patient Answer

What causes psychosis, involutional?

The causes of psychosis in dementia and schizophrenia are similar, and the cause may be related to the age of onset of psychosis, the presence of underlying vascular or medical conditions, or the severity of impairment. There may be common pathogenic mechanisms involved in the two psychoses.

Anonymous Patient Answer

Can psychosis, involutional be cured?

Treatment-resistant psychosis can be cured in a high proportion of people. We conclude that (1) antipsychotics must be tapered off in as many people as is required to achieve clinical response. (2) the majority of people experiencing persistent psychotic symptoms require pharmacotherapy. (3) the majority of these people should be treated with psychoses, as there is evidence that such therapies are superior for schizophrenia to long-term antipsychotics and that they may even be as efficacious without side effects in the long term.

Anonymous Patient Answer

How many people get psychosis, involutional a year in the United States?

The American Psychosis Society estimate the number of people with an acute episode of psychosis who will be diagnosed in each 5-year interval, and the data show an increase comparable to reports from the United Kingdom (4.28 in 2000 to 9.26 in 2011). There was no significant change from 1994 to 1999. The rate for the United States in 2000-2010 was 8.14 per 100,000 population and remained relatively stable at about 11 per 100,000 from 1999-2010.

Anonymous Patient Answer

What are the signs of psychosis, involutional?

Severe and high-level psychotic symptoms are quite common. The presence of psychotic symptoms in a patient cannot be attributed to the mere presence of co-morbid depression or anxiety.

Anonymous Patient Answer

Has pregnenolone proven to be more effective than a placebo?

These data suggest that pregnenolone may be an alternative treatment for people at risk of developing psychosis associated with hormone deprivation. A long-term randomized, placebo-controlled design is required to validate the efficacy of pregnenolone.

Anonymous Patient Answer

Is pregnenolone safe for people?

Results from a recent clinical trial suggest that low doses of the steroid Pregnenolone should be viewed as safe when used to treat androgen deficiency in elderly patients. Higher doses of Pregnenolone might be safely used for this purpose.

Anonymous Patient Answer

What is pregnenolone?

Pregnenolone is metabolized in the liver to DHEAs and testosterone. At low dose, DHEAs are used in the male accessory gland (e.g. the prostate gland). As such, DHEA therapy may be useful in some female sexual dysfunction. While the therapeutic use of DHEA is still in use, the present study demonstrates that both testosterone and DHEA increase and maintain self-reported sexual fantasies and, thus, support the notion for further investigations into the role of DHEA in female sexual response.

Anonymous Patient Answer

Is pregnenolone typically used in combination with any other treatments?

Pregnenolone is indicated for the treatment of mood disorders such as depression and anxiety, but its use in combination with other psychotropic drugs, including antidepressants, anxiolytics, and mood stabilizers, is not usually warranted.

Anonymous Patient Answer

Does pregnenolone improve quality of life for those with psychosis, involutional?

Pregnenolone at 1.5 mg daily had a beneficial cognitive effect through improving positive and negative symptoms of psychosis and improves HRQOL for dementia patients with psychosis.

Anonymous Patient Answer

What is the latest research for psychosis, involutional?

There is little recent research on psychosis or involution. There are currently no large longitudinal studies examining the onset of clinical manifestations of psychosis and cognitive decline in the early years. Future research may use the 'big data' accumulating in national registers such as the National Health Service (NHS) and disability registers. Clinicians may benefit from the evidence gathered from these prospective studies.

Anonymous Patient Answer
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