Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

• Sponsor: Durham VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00560781
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic	Drug: Pregnenolone or Placebo	N/A

Detailed Description

See brief summary

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. CAPS, BAC-A [Prospective]

Secondary Outcome Measures

1. PCL, CD-RISC, CGI, BDI-II [Prospective]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VAMC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Durham VA Medical Center

Investigators

• Principal Investigator: Christine E Marx, MD MA, Durham VAMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Durham VA Medical Center
• ClinicalTrials.gov Identifier: NCT00560781
• Other Study ID Numbers: VA IRB# 01023
• First Posted: Nov 20, 2007
• Last Update Posted: Feb 26, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Durham VA Medical Center: PTSD; Pregnenolone; Cognition
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Feb 26, 2014