Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans who experience symptoms of anxiety and depression. Participants will take a medication called pregnenolone to see if it helps improve their symptoms and overall functioning.
Are You a Good Fit for This Trial?
Rules you outPregnancyBreastfeedingModerate or severe Substance Use Disorders
You may be able to join if
I am a veteran enrolled for care at the Durham VAHCS.
I have a score of 20 or higher on the PHQ-ADS.
I can use non-hormonal birth control or I am not capable of becoming pregnant.
I do not need changes to my psychiatric medications during the study.
I can fully participate in the informed consent process.
You may not be able to join if
I have a history of allergy to pregnenolone.
I have certain medical disorders that could make taking pregnenolone unsafe.
I have a PTSD diagnosis with a score of 38 or higher on the PCL-5.
I currently have thoughts of harming myself or others.
I have an unstable serious medical illness.
I use benzodiazepines or opioids.
I have a diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
I have had changes in psychotherapy in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 unde…
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.
Trial Locations
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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 …
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
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