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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Post-traumatic Stress Disorder, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00993629

Run by

US Department of Veterans Affairs

People needed

0

Starts

2010-01-01

Expected to finish

2010-05-01

Last updated by the study team

2014-10-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Durham — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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