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Pregnenolone for PTSD
Study Summary
This trial will test whether the drug pregnenolone can help improve symptoms of PTSD and other co-occurring symptoms in veterans of the Iraq and Afghanistan wars. Veterans will be randomly assigned to receive either the drug or a placebo, and they will be assessed at regular intervals over the course of ten weeks.
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 don't expect to change my psychiatric meds during the study.You have had an allergic reaction to pregnenolone in the past.I don't have health issues that worsen with pregnenolone or PTSD treatment.I am using approved birth control or cannot become pregnant.I understand and can participate in the consent process.You currently have thoughts of hurting yourself or others and need immediate help from a doctor.If you have thought about hurting yourself in the past or have tried to hurt yourself before, but you don't currently need immediate help or have a plan to hurt yourself, you can still participate.I do not have a serious illness like a stroke or cancer in my prostate, uterus, or breast.I have been diagnosed with PTSD and my CAPS-5 score is at least 3.
- Group 1: Pregnenolone
- Group 2: Placebo
- 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
What other scientific investigations have included Pregnenolone as a variable?
"Currently, there are six ongoing studies investigating the use of pregnenolone. None of those studies are in phase 3. Although many of the trials for this medication are based in Dallas, Texas, there are seven locations running these studies."
Could you please share how many people are participating in this trial?
"The information on clinicaltrials.gov does show that this trial is looking for participants. It was originally posted on May 1st, 2019 and the last edit was on January 6th, 2022. They are hoping to find 90 individuals total from one site."
What are some of the risks associated with Pregnenolone?
"Pregnenolone's safety is based on some data collected from Phase 2 trials. However, as this drug has not yet reached Phase 3 testing, there is no efficacy data available."
Could I possibly be a candidate for this test?
"This trial is only for patients that have post traumatic stress disorder and are between the ages of 18-65. Out of the 90 total participants, there are still some available slots."
Will adults of a certain age still be able to experience the benefits of this proposed treatment?
"In order to participate in this particular clinical trial, applicants must be aged between 18 and 65 years old. There are 47 other trials for people who are under the age of 18 and 339 for those over the age of 65."
Are there any current vacancies for this clinical trial?
"Per the information available on clinicaltrials.gov, this study is still enrolling patients and recruiting from 1 site. The first posting was on May 1st, 2019 with the most recent update being January 6th, 2022. They are looking for a total of 90 individuals to complete the trial."
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