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

NCT ID: NCT00993629

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-05-31

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.

Conditions

Post-traumatic Stress Disorder; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

adjunctive pregnenolone

Group Type: ACTIVE_COMPARATOR

pregnenolone

Intervention Type: DRUG

Administered adjunctively to "treatment as usual"

Arm 2

adjunctive placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

adjunctive placebo

Interventions

pregnenolone

Administered adjunctively to "treatment as usual"

Intervention Type: DRUG

placebo

adjunctive placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria M Payne, MD MS

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Durham

Locations

VA Medical Center, Durham

Durham, North Carolina, United States

Countries

United States

Other Identifiers

B7064-W

Identifier Type: -

Identifier Source: org_study_id