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Pregnenolone for Chronic Traumatic Brain Injury

Phase 2

Waitlist Available

Led By Chris Marx, MD

Research Sponsored by Christine Marx, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Awards & highlights

Study Summary

This trial aims to find out if pregnenolone can improve psychological health, physical function, cognition, PTSD symptoms, and pain in veterans with chronic TBI. Participants will get paid for 6 visits and tests.

Who is the study for?

This trial is for OEF/OIF/OND-era U.S. Military Veterans aged 21-65 with a history of mild TBI since 2001, who can read English and consent to the study. They must not plan to change psychiatric or pain meds during the study, have no recent psychotropic interventions, and if female and able to become pregnant, must use birth control.Check my eligibility

What is being tested?

The trial tests whether pregnenolone improves psychological health, physical function, cognition, PTSD symptoms, and pain in veterans with chronic TBI compared to a placebo over eight weeks. It also examines biological effects of pregnenolone and its optimal safe dose.See study design

What are the potential side effects?

Potential side effects are not detailed here but will be monitored at each visit. Participants should report any adverse reactions they experience which could include typical drug-related issues such as headaches, dizziness or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in psychological health as measured by the Brief Symptom Inventory-18 (BSI)

Secondary outcome measures

Changes in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)

Changes in cognition as measured by the Stroop Color and Word Test (STROOP)

Changes in cognition as measured by the Wechsler Adult Intelligence Scale (WAIS-IV)

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PregnenoloneActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Christine Marx, MDLead Sponsor

Chris Marx, MDPrincipal InvestigatorDuke University

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05671692 — Phase 2

Traumatic Brain Injury Research Study Groups: Pregnenolone, Placebo

Traumatic Brain Injury Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05671692 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05671692 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the upper age limit of this clinical trial capped at eighty-five?

"This particular clinical trial has established an age restriction of 21 to 65. For those under 18, there are 59 studies they can join and 221 experiments for patients above the senior cutoff."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned Pregnenolone?

"The safety of Pregnenolone is rated a 2, based on research from Phase 2 trials. Although data shows it to be safe, no evidence exists yet supporting its efficacy."

Answered by AI

Is there still opportunity for enrollment in this clinical experiment?

"As indicated on the clinicaltrials.gov website, this research is not currently seeking participants. It was first published in January of 2023 and edited last December; however, there are 301 other trials actively recruiting at present."

Answered by AI

Am I eligible to enroll in this research?

"The purpose of this trial is to investigate the effects of traumatic brain injury (TBI) in 108 individuals aged 21-65. In order for a participant to qualify, they must meet further criteria such as being able to read and understand English, not requiring altered psychiatric or pain medications during the duration of their involvement in the study, no changes in psychotropic or behavioural interventions over two weeks before enrolment, and if female a negative pregnancy test will be required. Furthermore, sexually active patients must use medically accepted forms of contraception should they become pregnant during the study period."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans

Christine Marx, MD 2023. "Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05671692.