7-Keto DHEA for the Treatment of PTSD

October 7, 2015 updated by: Humanetics Corporation
The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main purpose of the study is to investigate the possible effect of 7-Keto Dehydroepiandrosterone (7-Keto DHEA) on decreasing Post Traumatic Stress Disorder Symptoms (PTSD) in a Veteran population. The study proposes, based on a 2006 report, that the use of the drug will show significant reduction in overall PTSD symptoms, a decrease in physiological stress response and higher patient-reported quality of life compared to placebo. This is a Phase 2, randomized, double-blind, crossover design with a placebo control. The sponsor for this study is Humanetics Corporation

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veteran status and enrolled for care in the Veteran Health Administration
  • Ages 18-64
  • Primary diagnosis of PTSD as assess by the clinician administered PTSD scale and independent clinical mental health evaluation

Exclusion Criteria:

  • psychosis
  • Dementia
  • Active alcohol and/or substance abuse or dependence
  • Active suicidal or homicidal ideation
  • Medical concerns that would exclude use of 7-Keto DHEA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Placebo Comparator
Drug: Placebo
Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
Active Comparator: Drug group
7 Keto-DHEA
Drug: 7-Keto Dehydroepiandrosterone
7-Keto Dehydroepiandrosterone, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
Other Names:
  • 7-Keto DHEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological benefits of 7-Keto DHEA (Dehydroepiandrosterone) in Veterans suffering from PTSD participating in the intervention through questionnaires and corresponding measurement of blood work for amounts of DHEA.
Time Frame: Four months

Outcome measures include analysis in symptoms of depression, anxiety, stress, trauma, and improved memory and cognitive functioning after treatment with 7-Keto DHEA. Measures will include psychological questionnaires as follows:

PTSD Checklist (PCL-C) Associated Symptoms of PTSD Scale (ASP) Trauma Symptom Inventory (TSI) Dissociative Experience Scale (DES) Beck Depression Inventory - II (BDI-II) Brief Symptom Inventory (BSI) Quality of Life Inventory (QOLI)
Four months
Physiological benefits of 7-Keto DHEA (Dehydroepiandrosterone) in Veterans suffering from PTSD participating in the intervention through questionnaires and corresponding measurement of blood work for amounts of DHEA.
Time Frame: Four months
DHEA (DHEA-S) concentrations (serum, saliva) are often elevated in men and women suffering from PTSD including that related to combat experience. Several studies have shown an association between higher levels of DHEA/DHEA-S and abatement of PTSD symptoms. Outcome measures include analysis of medical assessments via blood work; Complete Blood Count (CBC), Cortisol, and DHEA sulfate level
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanetics Corporation

Investigators

  • Principal Investigator: Alina Gonzalez-Mayo, MD, Bay Pines VAHCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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