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

Major Depressive Disorder Clinical Trial

Official title:

Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00993629
• Other study ID #: B7064-W
• Status: Withdrawn
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: October 23, 2014
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• pregnenolone
Administered adjunctively to "treatment as usual"
• placebo
adjunctive placebo

Locations

Country	Name	City	State
United States	VA Medical Center, Durham	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)		8 weeks	No