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OpenTrials
Completed

NCT Number: NCT00560781

Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VAMC

Durham, North Carolina, 27705, United States

About this study

See brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
  • Use of oral contraceptives or other hormonal supplementation such as estrogen.
  • Significant suicidal or homicidal ideation.
  • Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
  • 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
  • Female patients who are pregnant or breast-feeding.
  • Known allergy to study medication.
  • 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.

Treatment and study plan

Pregnenolone or Placebo

Drug

Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID

Primary outcomes

  1. CAPS, BAC-A

    Time frame: Prospective

Secondary outcomes

  1. PCL, CD-RISC, CGI, BDI-II

    Time frame: Prospective

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 20, 2007
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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