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Sponsored by: |
Durham VA Medical Center |
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Information provided by: | Durham VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00623506 |
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.
Condition | Intervention |
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Traumatic Brain Injury |
Dietary Supplement: Pregnenolone Dietary Supplement: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Adjunctive Pregnenolone in Veterans With Mild TBI |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Pregnenolone
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Dietary Supplement: Pregnenolone
Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)
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2: Placebo Comparator
Placebo
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Dietary Supplement: Placebo
Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)
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See brief summary
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer C. Naylor, PhD | (919) 286-0411 ext 7722 | naylorjc@duke.edu |
United States, North Carolina | |
Durham VA Medical Center | Recruiting |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Christine E Marx, MD, MA | Durham VAMC |
Responsible Party: | Durham Veterans Affairs Medical Center ( Christine E. Marx, MD ) |
Study ID Numbers: | VA IRB# 01209, VA IRB# 01209 |
Study First Received: | February 15, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00623506 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
TBI Pregnenolone Cognition |
Craniocerebral Trauma Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Brain Injuries |
Nervous System Diseases |