N/A
N=30
Adjunctive Pregnenolone in Veterans With Mild TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00623506 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Brief Assessment of Cognition in Affective Disorders (BAC-A) — 0.61; 0.80 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pregnenolone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Durham VA Medical Center
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Assessment of Cognition in Affective Disorders (BAC-A) |
0.61; 0.80 | — |
| SECONDARY Clinician Administered PTSD Scale (CAPS) |
-8.5; -7.3 | — |
| SECONDARY Quick Inventory of Depressive Symptomatology (QIDS) |
-1.09; -0.54 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00623506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.