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Pregnenolone for Menopausal Depression
Study Summary
This trial is testing if the drug pregnenolone can help reduce depressive symptoms in women with Major Depressive Disorder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 4 trial • 80 Patients • NCT01409096Trial Design
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Who is running the clinical trial?
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- I am experiencing changes in my menstrual cycle or symptoms of menopause.I experience 5 or more troubling hot flashes weekly.Women who are currently experiencing a severe form of sadness or depression, as diagnosed by a clinical interview.I use a hormonal IUD and my FSH level is over 20, indicating I might be in menopause.My family or I have a history of hormone-sensitive tumors.I use a hormonal IUD and my FSH level is over 20.My depression has not improved with treatment.My main mental health issue is not major depressive disorder.I haven't taken certain medications in the last 2 weeks.I haven't used supplements for menopause, depression, soy-based meds, or steroids in the last 2 weeks.My high blood pressure is not under control.I experience severe symptoms due to menopause.You agree to abstain from disallowed medications for the duration of the trial.I am a woman aged 40-67 and am going through or have just finished menopause.I have received hormone therapy for my reproductive organs within the last month.I have important health findings from recent tests or exams.
- Group 1: Pregnenlone (phase 1 and 2)
- Group 2: Placebo rerandom to placebo
- Group 3: Placebo responsive cont placebo
- Group 4: Placebo rerandom to pregnenolone
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are medical professionals still signing people up for this trial?
"That is correct. The trial, which was posted on September 1st 2018 and edited June 28th 2022, is currently looking for 144 individuals from a single site."
What is the sample size of this research project?
"That is correct, the online information regarding this clinical trial indicates that it currently recruiting patients. The original posting date was September 1st, 2018 with the most recent edit being June 28th, 2022. A total of 144 individuals are needed for the study taking place at a single location."
Are patients who are 18 years or older eligible for this program?
"According to the age requirements set out in this trial, the youngest eligible participant is 40 years old whereas the oldest person that meets the criteria is 67."
What does the scientific community know about Pregnenolone from past research?
"There are 6 active clinical trials studying Pregnenolone that are at different stages of development. While most of these studies taking place in Dallas, Texas, there 7 total locations for these trials."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- UT Southwestern Medical Center: < 24 hours
Average response time
- < 1 Day
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