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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 suspended participant recruitment.
(PI turned down funding.)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00993629
First received: October 7, 2009
Last updated: May 17, 2010
Last verified: May 2010
History of Changes
  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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
adjunctive pregnenolone
 Drug: pregnenolone
Administered adjunctively to "treatment as usual"
Placebo Comparator: 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
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
Department of Veterans Affairs
Investigators
Principal Investigator: Victoria M Payne, MD MS VA Medical Center, Durham
  More Information

No publications provided

Responsible Party: Payne, Victoria - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00993629     History of Changes
Other Study ID Numbers: B7064W
Study First Received: October 7, 2009
Last Updated: May 17, 2010
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
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 19, 2013