NCT01956279

Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the use of adjunctive pregnenolone for the following: 1. fatigue that has limited usual activity, 2. musculoskeletal pain involving 2 or more regions of the body and, 3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report) in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.

Conditions

• Fatigue
• Musculoskeletal Pain
• Cognitive Decline

Interventions

Type	Name	Description
DRUG	Pregnenolone	Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
DRUG	Placebo	Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-10-10
• Completion: 2018-10-10
• First posted: 2013-10-08
• Last updated: 2020-05-01
• Results posted: 2020-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study