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Completed

NCT Number: NCT01861847

7-Keto DHEA for the Treatment of PTSD

The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7-Keto Dehydroepiandrosterone

Drug

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

Placebo

Drug

Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.

Primary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Humanetics Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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