Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
See brief summary

Official Title
-----------------
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Conditions
-----------------
Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Drug: Pregnenolone or Placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pregnenolone | Drug: Pregnenolone or Placebo<br>* Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Pregnenolone or Placebo<br>* Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS, BAC-A |  | Prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCL, CD-RISC, CGI, BDI-II |  | Prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Pregnenolone, Cognition