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Allopregnanolone in Chronic Complex Traumatic Brain Injury

Not yet recruitingPhase 2NCT04003285
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \[primary endpoints\]. The investigators will also determine if ALLO improves functional outcome \[secondary endpoint\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.

Study details

Official title
Novel Regenerative Therapeutic in Chronic Complex TBI
Conditions
  • Traumatic Brain Injury (TBI)
Interventions
Sponsor
VA Office of Research and Development
Start date
2026-12-01
Primary completion
2027-06-01
Sex
All
Age range
from 21 Years to 62 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 traumatic brain injury (TBI) * Female participants who are pregnant or breast-feeding * Known a…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04003285