7-Keto DHEA for the Treatment of PTSD

Humanetics

Status and phase: Completed; Phase 2

Conditions: PTSD

Treatments: Drug: 7-Keto Dehydroepiandrosterone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01861847

2905

Details and patient eligibility

About

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

Full 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

Enrollment: 71 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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71 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Placebo

Drug group

Active Comparator group

Description:

7 Keto-DHEA

Treatment:

Drug: 7-Keto Dehydroepiandrosterone