7-Keto DHEA for the Treatment of PTSD

Phase 2

Completed

• Conditions: PTSD
• Interventions: Drug: Placebo; Drug: 7-Keto Dehydroepiandrosterone

• Registration Number: NCT01861847
• Lead Sponsor: Humanetics Corporation

Brief Summary

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

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-24
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Disposition First Submitted: 2015-09-22
• Status Verified: 2015-10
• Disposition First Submitted QC: 2015-10-07
• Last Update Submitted: 2015-10-07
• Disposition First Posted: 2015-10-29
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Placebo Comparator
Drug group	7-Keto Dehydroepiandrosterone	7 Keto-DHEA

Primary Outcome Measures

Name	Time	Method
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.	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)
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.	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

Trial Locations

Locations (1)

Bay Pines VA Healthcare System; 🇺🇸 Bay Pines, Florida, United States