← Back to Search

Neurosteroid

Pregnenolone for PTSD

Phase 2
Recruiting
Led By Jennifer C Naylor, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential
DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 years
Awards & highlights

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.

Who is the study for?
This trial is for Iraq/Afghanistan-era Veterans with PTSD who can commit to a 10-week study without changing their psychiatric medications. They must not have severe medical conditions, be pregnant or breastfeeding, use hormonal therapies, or have substance abuse issues. Stable non-hormonal birth control is required for women.Check my eligibility
What is being tested?
The study tests if pregnenolone improves PTSD symptoms compared to a placebo over 10 weeks. Participants will receive either the hormone or placebo and undergo regular health assessments during six in-person visits and check-in calls.See study design
What are the potential side effects?
While specific side effects are not listed, pregnenolone may cause hormonal changes that could affect mood and physical health. Allergic reactions are possible, as well as potential exacerbation of PTSD symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using approved birth control or cannot become pregnant.
Select...
I have been diagnosed with PTSD and my CAPS-5 score is at least 3.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinician Administered PTSD Scale for DSM-5 (Visit 6-Baseline)
Secondary outcome measures
Change in Brief Pain Inventory, Short Form (Visit 6-Baseline)
Change in Hamilton-Depression Inventory (Visit 6-Baseline)

Side effects data

From 2011 Phase 4 trial • 80 Patients • NCT01409096
3%
Sinusitis
3%
Corneal ulceration
3%
Skin abscess followed by allergic reaction to antibiotic used to treat it
3%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Pregnenolone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PregnenoloneExperimental Treatment1 Intervention
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
Group II: PlaceboPlacebo Group1 Intervention
Same as pregnenolone (active study medication), except placebo dispensed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregnenolone
2011
Completed Phase 4
~770

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD include neurosteroids like pregnenolone, SSRIs, SNRIs, and alpha-adrenergic receptor blockers. Neurosteroids such as pregnenolone modulate neurotransmitter systems and may have anxiolytic and neuroprotective effects, potentially improving mood and cognitive function. SSRIs and SNRIs work by increasing serotonin and norepinephrine levels in the brain, which can help alleviate symptoms of depression and anxiety commonly associated with PTSD. Alpha-adrenergic receptor blockers like prazosin reduce noradrenergic hyperactivity, which can help mitigate nightmares and sleep disturbances. These mechanisms are crucial for PTSD patients as they target the underlying neurobiological disruptions, offering symptom relief and improving overall quality of life.
PTSD: from neurobiology to pharmacological treatments.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,889 Total Patients Enrolled
Jennifer C Naylor, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
2 Previous Clinical Trials
192 Total Patients Enrolled

Media Library

Pregnenolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03799562 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Pregnenolone, Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Pregnenolone Highlights & Side Effects. Trial Name: NCT03799562 — Phase 2
Pregnenolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03799562 — Phase 2
~5 spots leftby Dec 2024