Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Drug: Pregnenolone or Placebo

• Registration Number: NCT00560781
• Lead Sponsor: Durham VA Medical Center

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

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-04
• Study Completion: 2007-05
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-25
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pregnenolone or Placebo	Pregnenolone
2	Pregnenolone or Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
CAPS, BAC-A	Prospective

Secondary Outcome Measures

Name	Time	Method
PCL, CD-RISC, CGI, BDI-II	Prospective

Trial Locations

Locations (1)

Durham VAMC; 🇺🇸 Durham, North Carolina, United States