NCT00623506 - Adjunctive Pregnenolone in Veterans With Mild TBI | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

November 30, 2012

Conditions

Traumatic Brain Injury

Interventions

DRUG

Pregnenolone

"Placebo for two weeks (during placebo lead-in), then:~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)"

DRUG

Placebo

"Placebo for two weeks (placebo lead in), then:~Placebo equivalent to Pregnenolone arm: 100 mg in divided doses (50 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 300 mg in divided doses (150 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 500 mg in divided doses (250 mg, PO, BID)"

Trial Locations (1)

27705

Durham VA Medical Center, Durham