7-Keto DHEA for the Treatment of PTSD

NCT01861847 | Completed Phase 2 DMC

• 1 other identifier: 2905
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

Drug group

ACTIVE COMPARATOR

7 Keto-DHEA

Drug: 7-Keto Dehydroepiandrosterone

Interventions

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.

Also known as: 7-Keto DHEA

Drug group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanetics Corporation: lead

Study Sites (1)

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

7-oxodehydroepiandrosterone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alina Gonzalez-Mayo, MD

  Bay Pines VAHCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 24, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

US (1)