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NCT00623506 · ClinicalTrials.gov registry record · NA
Adjunctive Pregnenolone in Veterans With Mild TBI
A NA study, sponsored by Durham VA Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT00623506 is a NA study that has completed, run by Durham VA Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT00623506, a NA study, has completed, sponsored by Durham VA Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Pregnenolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00623506
The ClinicalTrials.gov registry entry for NCT00623506 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durham VA Medical Center, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00623506 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00623506 about?
NCT00623506 is a clinical study titled "Adjunctive Pregnenolone in Veterans With Mild TBI". 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 functi...
What is the current status of trial NCT00623506?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2008-01. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00623506?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT00623506?
This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
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