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Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pregnenolone or Placebo
Sponsored by
Durham VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Pregnenolone, Cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Pregnenolone

Placebo

Outcomes

Primary Outcome Measures

CAPS, BAC-A

Secondary Outcome Measures

PCL, CD-RISC, CGI, BDI-II

Full Information

First Posted
November 19, 2007
Last Updated
February 25, 2014
Sponsor
Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00560781
Brief Title
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
Official Title
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durham VA Medical Center

4. Oversight

5. 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.
Detailed Description
See brief summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Pregnenolone, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pregnenolone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregnenolone or Placebo
Intervention Description
Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
Primary Outcome Measure Information:
Title
CAPS, BAC-A
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
PCL, CD-RISC, CGI, BDI-II
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Marx, MD MA
Organizational Affiliation
Durham VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

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