Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT05671692
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans
Sponsor:
Christine Marx, MD
Organization:
Study Overview
Official Title:
Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare pregnenolone and placebo (a placebo is a look-alike substance that contains no active drug) in Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)-Era Veterans with a history of chronic Traumatic Brain Injury (TBI). The main questions it aims to answer are:
* Does pregnenolone improve psychological health, overall physical function, cognition, symptoms of PTSD, and pain more than placebo over the 8-week study period, and what is the most effective dose of the drug that is safe and well-tolerated?
* What are the biological effects of pregnenolone, and how do pregnenolone and other molecules change over the course of treatment? (and do pregnenolone and other molecules predict clinical improvement?)
Participants who are eligible and consent to participate in the study will:
* be randomized in a 1:1 ratio to take pregnenolone or placebo
* be given pregnenolone or placebo to take each day at home
* will participate in 6 visits over 11 weeks for tests, exams and procedures that are for study purposes (each visit will last 1.5 - 3 hours)
* be evaluated at each visit to determine if there are any bad reactions to the study drug and if study participation is still appropriate
* be financially compensated for their visit time and travel cost
* Does pregnenolone improve psychological health, overall physical function, cognition, symptoms of PTSD, and pain more than placebo over the 8-week study period, and what is the most effective dose of the drug that is safe and well-tolerated?
* What are the biological effects of pregnenolone, and how do pregnenolone and other molecules change over the course of treatment? (and do pregnenolone and other molecules predict clinical improvement?)
Participants who are eligible and consent to participate in the study will:
* be randomized in a 1:1 ratio to take pregnenolone or placebo
* be given pregnenolone or placebo to take each day at home
* will participate in 6 visits over 11 weeks for tests, exams and procedures that are for study purposes (each visit will last 1.5 - 3 hours)
* be evaluated at each visit to determine if there are any bad reactions to the study drug and if study participation is still appropriate
* be financially compensated for their visit time and travel cost
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: