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Trial record 51 of 236 for:    PRASTERONE

7-Keto DHEA for the Treatment of PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861847
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Humanetics Corporation

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE May 24, 2013
Last Update Posted Date October 29, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
  • 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: PCL-C (PTSD Checklist) ASP (Associated Symptoms of PTSD Scale) TSI (Trauma Symptom Inventory) DES (Dissociative Experience Scale) BDI-II (Beck Depression Inventory - II) BSI (Brief Symptom Inventory) QOLI (Quality of Life Inventory)
  • 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; CBC (Complete Blood Count), Cortisol, and DHEA sulfate level
Change History Complete list of historical versions of study NCT01861847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 7-Keto DHEA for the Treatment of PTSD
Official Title  ICMJE 7-Keto DHEA for the Treatment of PTSD
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Drug: 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.
    Other Name: 7-Keto DHEA
  • Drug: Placebo
    Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
Study Arms  ICMJE
  • Placebo Comparator: Placebo Group
    Placebo Comparator
    Intervention: Drug: Placebo
  • Active Comparator: Drug group
    7 Keto-DHEA
    Intervention: Drug: 7-Keto Dehydroepiandrosterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2015)
71
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2013)
120
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01861847
Other Study ID Numbers  ICMJE 2905
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Humanetics Corporation
Study Sponsor  ICMJE Humanetics Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alina Gonzalez-Mayo, MD Bay Pines VAHCS
PRS Account Humanetics Corporation
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP