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Adjunctive Pregnenolone in Veterans With Mild TBI

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00623506
First received: February 15, 2008
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  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
 Drug: Pregnenolone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Pregnenolone in Veterans With Mild TBI

Resource links provided by NLM:

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 2012
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pregnenolone
 Drug: 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)
Placebo Comparator: 2
Placebo
 Drug: 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:

  1. 18-55 years of age, any ethnic group, either sex
  2. History of mild TBI since September 2001. TBI occurring at age 18 or older.
  3. 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).
  4. Ability to participate fully in the informed consent process.
  5. No anticipated need to alter medications for the 10-week duration of the study.

Exclusion Criteria:

  1. For this pilot study, we will exclude patients who report a history of seizures.
  2. Serious unstable medical illness. History of cerebrovascular accident, prostate, uterine, or breast cancer. Use of oral contraceptives or other hormonal supplementation such as estrogen.
  3. Current active suicidal and/or homicidal ideation, intent or plan.
  4. Concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
  5. Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
  6. Female patients who are pregnant or breast-feeding.
  7. Known allergy to study medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623506

Locations
United States, North Carolina
Durham VA Medical Center
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 VA Medical Center
ClinicalTrials.gov Identifier: NCT00623506     History of Changes
Other Study ID Numbers: VA IRB# 01209, VA IRB# 01209
Study First Received: February 15, 2008
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Durham VA Medical Center:
TBI
Pregnenolone
Cognition

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013