7-Keto DHEA for the Treatment of PTSD

NCT ID: NCT01861847

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo Group

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Drug group

7 Keto-DHEA

Group Type ACTIVE_COMPARATOR

7-Keto Dehydroepiandrosterone

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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7-Keto DHEA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanetics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alina Gonzalez-Mayo, MD

Role: PRINCIPAL_INVESTIGATOR

Bay Pines VAHCS

Locations

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Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2905

Identifier Type: -

Identifier Source: org_study_id

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