PTSDPhase 2NCT01861847
7-Keto DHEA for the Treatment of PTSD
A Phase 2 study testing 7-Keto Dehydroepiandrosterone in people with PTSD, run by Humanetics Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- PTSD
- What is being tested?
- 7-Keto Dehydroepiandrosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
About this study
The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).
Read the 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
- Conditions
- PTSD
- Being tested
- 7-Keto Dehydroepiandrosterone, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Keto DehydroepiandrosteroneDrug
Also called 7-Keto DHEA
7-Keto Dehydroepiandrosterone, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
PlaceboDrug
Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo Comparator Receives: Drug: Placebo |
| Drug group | Active comparator | 7 Keto-DHEA Receives: Drug: 7-Keto Dehydroepiandrosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alina Gonzalez-Mayo, MD, Principal investigator, Bay Pines VAHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861847
- Sponsor's protocol ID
- 2905
- Status last verified
- Oct 2015
- First submitted
- 10 May 2013
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7-Keto DHEA for the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT01861847
- Acronym / sponsor ID
- 2905
- Conditions
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Humanetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo Comparator |
| Drug group | Active comparator | Drug: 7-Keto Dehydroepiandrosterone7 Keto-DHEA |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-Keto DehydroepiandrosteroneAlso: 7-Keto DHEA7-Keto Dehydroepiandrosterone, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment. | Drug | Drug group |
| PlaceboPlacebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment. | Drug | Placebo Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Gonzalez-Mayo, MD principal investigator
Bay Pines VAHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7-Keto Dehydroepiandrosterone in people with PTSD, run by Humanetics Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.