Pregnenolone for Anxiety and Depression
Trial Summary
Will I have to stop taking my current medications?
You won't have to stop taking your current psychiatric medications, but you can't change them for 4 weeks before starting the study. If you're using benzodiazepines or opioids, you can't participate in the trial.
What evidence supports the effectiveness of the drug pregnenolone for anxiety and depression?
Research suggests that pregnenolone may help improve mood in people with mood disorders, as one study found it led to a reduction in depressive symptoms in patients with a history of substance use. Additionally, it showed some effectiveness in reducing irritability in adults with autism spectrum disorder, which may indirectly suggest potential benefits for mood-related conditions.12345
Is pregnenolone generally safe for humans?
How is the drug pregnenolone unique for treating anxiety and depression?
Pregnenolone is unique because it is a neurosteroid that may improve mood and depressive symptoms by affecting brain receptors and possibly interacting with microtubule associated protein 2 (MAP2), which is a novel target for antidepressant therapy. It has shown potential benefits in mood disorders, especially in patients with bipolar disorder, and is generally well-tolerated.1371011
What is the purpose of this trial?
Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. Converging data suggest that pregnenolone is a promising pharmacological agent for treating multiple psychiatric symptoms and functional impairment. The investigators thus propose to conduct a clinical trial of pregnenolone in Veterans with anxiety and depression symptoms. Pregnenolone has minimal side effects, and the prior research demonstrates that pregnenolone is well-tolerated by Veterans. Treatment with pregnenolone could thus be an efficacious new therapeutic for Veterans experiencing depression, anxiety, poor sleep quality and chronic pain conditions.
Research Team
Jennifer C Naylor, PhD
Principal Investigator
Durham VA Medical Center, Durham, NC
Christine E Marx, MD MA
Principal Investigator
Durham VA Medical Center, Durham, NC
Eligibility Criteria
This trial is for veterans experiencing symptoms of anxiety and depression, who may also be dealing with poor sleep quality and chronic pain. To participate, they should not have any conditions that would exclude them from the study as per the trial's specific criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Placebo Lead-in
Participants receive placebo for 2 weeks before randomization
Treatment
Participants receive either pregnenolone or placebo for 8 weeks with flexible dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pregnenolone
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor