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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00993629
First Posted: October 12, 2009
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: Double
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 VA Office of Research and Development:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993629


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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00993629     History of Changes
Other Study ID Numbers: B7064-W
First Submitted: October 7, 2009
First Posted: October 12, 2009
Last Update Posted: October 27, 2014
Last Verified: October 2014

Keywords provided by VA Office of Research and Development:
PTSD
Depression
Neurosteroids

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