Adjunctive Pregnenolone in Veterans With Mild TBI

Completed · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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 following TBI, including cognitive symptoms (impaired attention, processing speed, executive functioning), as well as behavioral symptoms such as anxiety, depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al. 2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al. 2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could therefore result in a multi-targeted treatment approach, potentially improving cognitive deficits as well as anxiety and depression symptoms following TBI.

Key facts

Study ID

NCT00623506

Run by

Durham VA Medical Center

People needed

30

Starts

2008-01-01

Expected to finish

2012-11-01

Last updated by the study team

2013-06-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Durham VA Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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