Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

• Status: Withdrawn
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development

Criteria

Inclusion Criteria:

• Diagnosis of PTSD,

• diagnosis of MDD,

• age 18-55,

• no change in psychotropic medication for >=4 weeks,

• no anticipated need to to alter psychotropic medication for duration of study

Exclusion Criteria:

• Unstable medical/neurological illness,

• diagnosis of bipolar disorder, schizophrenia or other psychotic disorder,

• cognitive disorder,

• substance dependence,

• positive urine drug screen at screening,

• use of hormonal supplementation,

• pregnancy/lactation,

• female patients who are sexually active and not using acceptable non-hormonal birth control,

• initiation/change of psychotherapy within 3 months of randomization,

• recent/current electroconvulsive therapy,

• regular use of opiates/barbiturates/benzodiazepines