Could a single infusion ease brain injury symptoms in veterans?
NCT ID NCT04003285
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study tests whether a drug called allopregnanolone can reduce depression and pain in veterans who have had a mild traumatic brain injury (TBI). About 132 participants will receive either the drug or a placebo through an IV. Researchers will check symptoms during the infusion and at several follow-up visits. The goal is to see if this treatment can improve daily function and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 62 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Any ethnic group * History of mild traumatic brain injury (TBI) since 2001 and service in the U.S. Military since 9/11/01 (OEF/OIF/OND era) * The investigators will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force, with the exception of seizure and Glasgow Coma Scale score criteria (not available for these participants) with 1 or more of the following: * confusion or disorientation * loss of consciousness for 30 minutes or less * post-traumatic amnesia for less than 24 hours * and/or other transient neurological abnormalities such as focal signs, and intracranial lesion not requiring surgery * Ability to participate fully in the informed consent process * Hamilton Depression Rating Scale (HDRS) score 14 (HAM-D range for moderate depression=14-18) * Participants will meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder (by SCID) * The presence of psychotic features will be exclusionary * Single episodes or recurrent episodes will be permissible for study entry (the investigators will examine treatment responses in those who have had single depressive episodes versus those who have had multiple depressive episodes in exploratory sensitivity analyses * BPI (Brief Pain Inventory, Short Form) 'current' pain intensity rating item score 4 (scale of 0-10) * Pain must be musculoskeletal in nature * No anticipated need to alter psychiatric medications for 14-day duration of study involvement * No changes in psychotropic or behavioral interventions during the study or in the 2 weeks prior to study enrollment * Concomitant medications for co-occurring medical conditions are permissible for stable medical conditions that are reasonably well-controlled * for example, hypertension medications, statins, and oral hypoglycemic medications would generally be permissible if they appear to be effectively treating the underlying condition Exclusion Criteria: * Participants with current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern * Medications that could potentially confound study outcomes (for example, prednisone) are exclusionary * Current DSM-5 diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI * Female participants who are pregnant or breast-feeding * Known allergy to study medication * Benzodiazepine, barbiturate, or opioid use within the last 2 weeks is exclusionary * Substance use disorder (DSM-5), other than nicotine use disorder * A serious medical illness, defined as an illness that requires hospitalization for additional care at the time of screening or one that has required hospitalization in the last month. * Any co-occurring medical illness should have a history of stable outpatient management * Report of a history of seizures, a history of stroke, a history of prostate cancer (or any other cancer other than non-melanoma skin cancer), a history of myocardial infarction, the presence of congestive heart failure, or any other serious health condition that would likely preclude safe study participation in the medical opinion of the PI or in consultation with the participant's Primary Care Provider (PCP)/other health care provider * Use of oral contraceptives, a hormone-releasing IUD, or other hormonal supplementation such as estrogen or progesterone, as there is a theoretical risk that a metabolite such as ALLO could potentially impact efficacy of oral contraceptives or estrogen replacement
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
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Other studies related to the condition(s) this trial covers.
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- Can sound, heat, and pressure rewire the depressed brain?
- Can two natural supplements boost antidepressants?
- Can a short talk therapy boost TB recovery?
- Can a targeted magnetic pulse rewire the depressed brain?