Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
This study is ongoing, but not recruiting participants.
Sponsor:
Durham VA Medical Center
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560781
First received: November 19, 2007
Last updated: December 5, 2012
Last verified: December 2012
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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:
MedlinePlus related topics:
Post-Traumatic Stress Disorder
Drug Information available for:
Pregnenolone
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | May 2013 |
| 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:
- 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.
Contacts and Locations
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: | December 5, 2012 |
| 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 May 23, 2013