Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
Completed · Not applicable · Has a placebo group
Conditions studied: Stress Disorders, Post-Traumatic
In brief
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.
Key facts
- Study ID
- NCT00560781
- Run by
- Durham VA Medical Center
- People needed
- 27
- Starts
- 2006-04-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2014-02-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Durham VAMC — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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