Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560781
• Other study ID #: VA IRB# 01023
• Status: Completed
• Phase: N/A
• First received: November 19, 2007
• Last updated: February 25, 2014
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: February 2014
• Source: Durham VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Pregnenolone or Placebo
Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID

Locations

Country	Name	City	State
United States	Durham VAMC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Durham VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS, BAC-A		Prospective	No
Secondary	PCL, CD-RISC, CGI, BDI-II		Prospective	No