Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560781
First received: November 19, 2007
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.


Condition Intervention
Stress Disorders, Post-Traumatic
Drug: Pregnenolone or Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • CAPS, BAC-A [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PCL, CD-RISC, CGI, BDI-II [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pregnenolone
Drug: Pregnenolone or Placebo
Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
Placebo Comparator: 2
Placebo
Drug: Pregnenolone or Placebo
Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-65 years of age, any ethnic group, either sex
  2. DSM-IV diagnosis of PTSD by MINI (see schedule of events)
  3. No change in SSRI medications for > 4 weeks.
  4. No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
  5. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria:

  1. Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
  2. Use of oral contraceptives or other hormonal supplementation such as estrogen.
  3. Significant suicidal or homicidal ideation.
  4. Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
  5. Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months
  6. Female patients who are pregnant or breast-feeding.
  7. Known allergy to study medication.
  8. Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the FDA; patients taking these agents will not be eligible for this study.
  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: NCT00560781

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christine E Marx, MD MA Durham VAMC
  More Information

No publications provided

Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00560781     History of Changes
Other Study ID Numbers: VA IRB# 01023
Study First Received: November 19, 2007
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Durham VA Medical Center:
PTSD
Pregnenolone
Cognition

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 23, 2014