Adjunctive Pregnenolone in Veterans With Mild TBI - Full Text View

Sponsored by:	Durham VA Medical Center
Information provided by:	Durham VA Medical Center
ClinicalTrials.gov Identifier:	NCT00623506

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Traumatic Brain Injury

Drug Information available for: Pregnenolone

U.S. FDA Resources

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:

The primary endpoints will be changes in cognitive symptoms over the course of the study (BAC-A) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcome measures will be PTSD symptoms (CAPS), depressive symptoms (QIDS), and other cognitive scales (CPT, Trail Making, and WCST) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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
1: Active Comparator Pregnenolone	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)
2: Placebo Comparator Placebo	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)

Detailed Description:

See brief summary

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623506

Contacts

Contact: Jennifer C. Naylor, PhD

(919) 286-0411 ext 7722

naylorjc@duke.edu

Locations

United States, North Carolina
Durham VA Medical Center	Recruiting
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Durham VA Medical Center

Investigators

Principal Investigator:

Christine E Marx, MD, MA

Durham VAMC

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Keywords provided by Durham VA Medical Center:

TBI
Pregnenolone
Cognition

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on September 03, 2009