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Pregnenolone for Mild TBI in OEF/OIF Veterans
NCT01336413Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2013
- Primary completion
- Feb 2016
- Countries
- 1
- Sponsor
- VA Office of Research & Development
- Modality
- Small Molecules
- Drugs
- pregnenolone
- Conditions
- traumatic brain injury (TBI)
01
Overview
Phase 2, randomised, double-blind trial in traumatic brain injury (TBI) comparing Pregnenolone with Placebo (2 arms). Primary endpoints: Clinician-Administered PTSD Scale Cluster D Symptoms at 8 weeks and Tower of London Test at 8 weeks. Started Oct 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Pregnenolone
Pregnenolone titration: 50 mg BID x 14 days, 150 mg BID x 14 days, 250 mg BID thereafter.
Placebo
Placebo matching the active comparator regimen.
03
Who it enrols
OEF/OIF Veterans aged 21-55 with a history of mild TBI since 2001. Excludes patients with seizures, bipolar disorder, schizophrenia, current suicidal ideation, substance dependence, or serious unstable medical illness.
04
Endpoints
Primary
Clinician-Administered PTSD Scale Cluster D Symptoms
Tower of London Test
Secondary
Beck Depression Inventory-II
Brief Assessment of Cognition Composite Score
Clinician-Administered PTSD Scale Total Score
Connor-Davidson Resilience Scale
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