Allopregnanolone in Chronic Complex Traumatic Brain Injury
ConditionTraumatic Brain Injury (TBI)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-62
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
21-62 years of age, any ethnic group, either sex
History of mild TBI since 2001 and service in the U.S. Military since 9/11/01 (OEF/OIF/OND era)
confusion or disorientation
loss of consciousness for 30 minutes or less
Disqualifiers
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
Trial design
Treatments tested in this trial
- Placebo
- Allopregnanolone
- Allopregnanolone
Treatment groups
132 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov