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

This study has been withdrawn prior to enrollment.
(PI turned down funding.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00993629
First received: October 7, 2009
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Post-traumatic Stress Disorder
Major Depressive Disorder
Drug: pregnenolone
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
adjunctive pregnenolone
Drug: pregnenolone
Administered adjunctively to "treatment as usual"
Placebo Comparator: Arm 2
adjunctive placebo
Drug: placebo
adjunctive placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993629

Locations
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Victoria M Payne, MD MS VA Medical Center, Durham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00993629     History of Changes
Other Study ID Numbers: B7064-W
Study First Received: October 7, 2009
Last Updated: October 23, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
PTSD
Depression
Neurosteroids

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014