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

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT00993629

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder Major Depressive Disorder	Drug: pregnenolone Drug: placebo	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 adjunctive pregnenolone	Drug: pregnenolone Administered adjunctively to "treatment as usual"
Placebo Comparator: Arm 2 adjunctive placebo	Drug: placebo adjunctive placebo

Arm

Intervention/Treatment

Active Comparator: Arm 1

adjunctive pregnenolone

Drug: pregnenolone

Administered adjunctively to "treatment as usual"

Placebo Comparator: Arm 2

adjunctive placebo

Drug: placebo

adjunctive placebo

Outcome Measures

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS) [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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