Status:
COMPLETED
Adjunctive Pregnenolone in Veterans With Mild TBI
Lead Sponsor:
Durham VA Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres. Delayed symptoms may occur...
Detailed Description
See brief summary
Eligibility Criteria
Inclusion
- 18-55 years of age, any ethnic group, either sex
- History of mild TBI since September 2001. TBI occurring at age 18 or older.
- We will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force (Holm et al.2005), with the exception of the Glasgow Coma Scale Score criteria (not available for these participants).
- Ability to participate fully in the informed consent process.
- No anticipated need to alter medications for the 10-week duration of the study.
Exclusion
- For this pilot study, we will exclude patients who report a history of seizures.
- Serious unstable medical illness. History of cerebrovascular accident, prostate, uterine, or breast cancer. Use of oral contraceptives or other hormonal supplementation such as estrogen.
- Current active suicidal and/or homicidal ideation, intent or plan.
- Concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
- Current DSM-IV (Diagnostic and Statistical Manual, Fourth Edition) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
- Female patients who are pregnant or breast-feeding.
- Known allergy to study medication.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00623506
Start Date
January 1 2008
End Date
November 1 2012
Last Update
June 20 2013
Active Locations (1)
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1
Durham VA Medical Center
Durham, North Carolina, United States, 27705