COMPLETED

Neurosteroids for PTSD in Veterans

Conditions

Posttraumatic Stress Disorder Depression Pain Clinical Trial Veteran Supplement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration is 10 weeks. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short "check-in" phone calls.

Official Title

Neurosteroid Intervention for PTSD in Iraq/Afghanistan-era Veterans

Quick Facts

Study Start:2019-05-01

Study Completion:2025-07-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03799562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3 * Females 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 * No anticipated need to alter psychiatric medications for duration of study involvement * Ability to participate fully in the informed consent process	* History of allergy to pregnenolone * Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms * Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern * Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted * 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) * Medical conditions not well controlled will be excluded, at the discretion of the PI and Medical Team * Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to: * antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone * mood stabilizers such as carbamazepine, divalproex, lamotrigine, topiramate * atypical antipsychotics, and other agents including prazosin * However, there may be no changes in psychotropic medications for PTSD 4 weeks prior to study randomization * Benzodiazepine use * 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) * Initiation or change in psychotherapy within 3 months of randomization * i.e., psychotherapy must be stable for 3 months prior to study start * Participants on hormonal therapies such as finasteride or hormonal birth control * Female participants who are pregnant or breast-feeding * As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry * Mild Alcohol Use Disorder is not exclusionary, at the judgment of the PI and her medical team

Inclusion Criteria

Exclusion Criteria

* DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3
* Females 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
* No anticipated need to alter psychiatric medications for duration of study involvement
* Ability to participate fully in the informed consent process

* History of allergy to pregnenolone
* Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms
* Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern
* Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted
* 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)
* Medical conditions not well controlled will be excluded, at the discretion of the PI and Medical Team
* Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to:
* antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone
* mood stabilizers such as carbamazepine, divalproex, lamotrigine, topiramate
* atypical antipsychotics, and other agents including prazosin
* However, there may be no changes in psychotropic medications for PTSD 4 weeks prior to study randomization
* Benzodiazepine use
* 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)
* Initiation or change in psychotherapy within 3 months of randomization
* i.e., psychotherapy must be stable for 3 months prior to study start
* Participants on hormonal therapies such as finasteride or hormonal birth control
* Female participants who are pregnant or breast-feeding
* As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry
* Mild Alcohol Use Disorder is not exclusionary, at the judgment of the PI and her medical team

Contacts and Locations

Principal Investigator

Jennifer C Naylor, PhD

PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Jennifer C Naylor, PhD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-01

Study Completion Date2025-07-14

Study Record Updates

Study Start Date2019-05-01

Study Completion Date2025-07-14

Terms related to this study

Keywords Provided by Researchers

Depression
Pain
Clinical Trial
Veteran
Supplement

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder