A New Intervention to Improve Function in Veterans With Anxiety and Depression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 8 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Following a 2-week placebo-only lead-in period, 84 subjects will be enrolled and randomly assigned to receive PREG or placebo for 8 weeks (flexible dosing strategy)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether pregnenolone can help Veterans with anxiety and depression do better in daily life. It will also look at symptoms that often occur together, such as poor sleep and long-term pain.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are a Veteran enrolled for care at the Durham Veterans Affairs Health Care System.
- You score at least 20 on the PHQ-ADS, a survey of anxiety and depression symptoms.
- Women who can become pregnant must use non-hormonal birth control approved by the study and medical team. Pregnenolone may make birth control pills less effective.
- You do not expect to need changes to your mental health medicines during the study.
- You can fully take part in learning about the study and giving consent.
Who can't join
- You have an allergy to pregnenolone, or a health condition that could make it unsafe or worsen symptoms. This includes serious, unstable illness, such as a history of stroke or prostate, uterine, or breast cancer, as judged by the study team.
- You have post-traumatic stress disorder (PTSD), with a score of 38 or higher on the study’s PTSD screening.
- You currently have thoughts of suicide or harming others that need medical help or pose an immediate risk. Past attempts or thoughts without these concerns do not rule you out.
- You use benzodiazepines, a type of medicine for anxiety or sleep, or opioids, a type of pain medicine.
- You have bipolar disorder, schizophrenia, another disorder affecting your sense of reality, or thinking or memory problems caused by a medical condition other than a mild brain injury.
- Your mental health medicines changed in the 4 weeks before study group assignment, or you started or changed talk therapy in the 3 months before assignment.
- You are pregnant or breastfeeding.
- You had a moderate or severe substance use disorder in the month before joining. Caffeine and tobacco use disorders do not count.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Veterans enrolled for care at the Durham Veterans Affairs Health Care System (VAHCS) 2. Veterans who score a minimum score of 20 or higher (moderate symptoms) on the PHQ-ADS (Kroenke et al 2017) 3. Oral pregnenolone could reduce the effectiveness of oral contraceptives, thus women will be required to use a medically and study-approved contraceptive or otherwise not be of child-bearing potential. Birth control methods must be non-hormonal. 4. No anticipated need to alter psychiatric medications for duration of study involvement 5. Ability to participate fully in the informed consent process Exclusion Criteria: 1. History of allergy to pregnenolone (PREG) 2. Medical disorders that may preclude safe administration of PREG or exacerbate mental or physical health symptoms 3. Post-traumatic stress disorder (PTSD) diagnosis, as per the PCL-5 with LEC-5, scores of 38 or higher 4. Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern. Prior attempts or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted 5. Serious unstable medical illness, such as history of cerebrovascular accident, prostate, uterine or breast cancer, others (at the discretion of the PI and medical oversight team) 6. Standard pharmacological interventions for mental health disorders will not be exclusionary; however, there may be no changes in psychotropic medications for mental or physical health conditions 4 weeks prior to study randomization 7. Benzodiazepine or opioid use 8. Current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than mild TBI (assessed at screening) 9. Initiation or change in psychotherapy within 3 months of randomization (i.e., psychotherapy must be stable for 3 months prior to study start 10. Due to lack of safety data in pregnant and breast-feeding women, female participants who are pregnant or breast-feeding will be excluded 11. As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry
Study sites (1)
NC
- Durham VA Medical Center, Durham, NC · Durham, NC 27705-3875Jennifer C Naylor, PhD · Study contact · (919) 286-0411 ext. 7722 · jennifer.naylor2@va.govChristine E. Marx, MD MA · Principal investigatorJennifer C Naylor, PhD · Principal investigatorMore trials in Durham