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

US Department of Veterans Affairs

Overview

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.

PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Post-traumatic Stress Disorder Major Depressive Disorder

Interventions

pregnenoloneDRUG

Administered adjunctively to "treatment as usual"

placeboDRUG

adjunctive placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

VA Medical Center, Durham

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Clinician Administered PTSD Scale (CAPS)

Time frame: 8 weeks

Data from ClinicalTrials.gov

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