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

Phase 2

Withdrawn

• Conditions: Major Depressive Disorder; Post-traumatic Stress Disorder
• Interventions: Drug: placebo; Drug: pregnenolone

• Registration Number: NCT00993629
• Lead Sponsor: US Department of Veterans Affairs

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.

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 Timeline

• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-09
• Study First Posted: 2009-10-12
• Study Start: 2010-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	placebo	adjunctive placebo
Arm 1	pregnenolone	adjunctive pregnenolone

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale (CAPS)	8 weeks

Trial Locations

Locations (1)

VA Medical Center, Durham; 🇺🇸 Durham, North Carolina, United States