Neurosteroids in PTSD - Biomarkers to Therapeutics

Status Terminated

Clinical Trial Summary

The purpose of this research is to determine if a study medication called Dehydroepiandrosterone (DHEA) helps to reduce PTSD symptoms in OEF/OIF/OND Veterans. In addition to finding out if DHEA is effective for treating PTSD symptoms, this research seeks to determine if DHEA is effective in treating other symptoms, such as depression and anxiety. Depression and anxiety are symptoms that are frequently present in Veterans who are experiencing PTSD. Another purpose of this research is to takes pictures of the brain using magnetic resonance imaging (MRI) and blood levels of various small molecules including neurosteroids and also proteins, which may be affected by the study drug and/or related to symptoms in Veterans with PTSD. This study seeks to determine if DHEA is changed to other compounds after it is taken by mouth and the safety and effectiveness of DHEA in Veterans with PTSD. This is an "add-on" study and Veterans enrolled in the study will continue to take all of their current medications without any changes (also called "usual care"), and DHEA or a sugar pill (also called a "placebo") will then be added to their current medication regimen.

Clinical Trial Description

This is a parallel-group, double-blind, placebo (PBO)-controlled, randomized Phase 2 pilot study using adjunctive dehydroxyepiandrosterone [DHEA (400 mg)] to establish Proof of Concept (POC) for use of this agent in Veterans with PTSD. The investigators' first objective is POC target engagement to evaluate a one-time adjunctive oral dose of DHEA (400 mg) relative to PBO on the neuronal circuity of fear-anxiety-emotion connectivity. This will be achieved by comparing pre- to post-treatment changes in amygdala-hippocampal functional connectivity to DHEA and PBO during fMRI activation. The investigators hypothesize that compared with PBO, DHEA will increase task-associated fMRI functional connectivity between the amygdala and hippocampus (primary outcome). The second objective is to determine if an 8-week treatment with adjunctive DHEA is superior to PBO in reducing symptoms of PTSD (CAPS-5) and depression (BDI) in OEF/OIF/OND Veterans, and enhancing resilience (CD-RISC). The investigators hypothesize that 400mg DHEA will result in reduced PTSD and depression symptom severity relative to PBO, as determined by a pre- to post-treatment decrease in CAPS-5 and BDI scores, respectively, with enhancement in resilience scores using the CD-RISC at 6-weeks. The third objective is to evaluate the impact of DHEA relative to PBO on serum neurosteroid levels in OEF/OIF/OND Veterans with PTSD. The investigators hypothesize that DHEA will result in a statistically-significant increase in serum neurosteroid levels (DHEA, DHEAS, androsterone) relative to PBO, as determined by pre- to post-treatment reductions in PTSD symptoms severity. This association will be evaluated by correlating neurosteroid levels with PTSD, depression, and resilience scores over 6 weeks of treatment. The exploratory objective is to determine preliminary evidence for an association of fMRI and myelin integrity measures of fear-anxiety-emotion circuits with serum neurosteroid levels and treatment response to DHEA. Changes in myelin integrity following DHEA treatment will be evaluated using novel susceptibility diffusion imaging [STI]), as DHEA impacts myelination in preclinical rodent models. The investigators will also determine if serum neurosteroid levels are correlated with myelin integrity on STI. The investigators hypothesize that fMRI and myelin integrity of fear-anxiety circuits will correlate with serum neurosteroids and treatment response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03491007
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Terminated
Phase	Phase 2
Start date	July 8, 2019
Completion date	November 16, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03384706` - A Comparison of CPT Versus ART Versus WL	N/A
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Completed	`NCT03129204` - Sensation Awareness Focused Training for Spouses	N/A
Recruiting	`NCT05651295` - A Precision Medicine Approach to Target Engagement for Emotion Regulation	N/A
Completed	`NCT05113277` - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention	N/A
Recruiting	`NCT05327504` - Written Exposure Therapy for Veterans With SUD and PTSD	N/A
Recruiting	`NCT05843695` - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Completed	`NCT00644423` - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT02989987` - NET for SGBV Survivors in Eastern DR Congo	N/A
Completed	`NCT02320799` - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya	N/A
Recruiting	`NCT02293291` - Thermal Clinic Treatment in Gulf War Illness	Phase 1/Phase 2
Completed	`NCT02242136` - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants	N/A
Completed	`NCT01911585` - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure	N/A
Completed	`NCT02720497` - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01693978` - Contingency Outcomes in Prolonged Exposure	N/A
Completed	`NCT01469754` - Longitudinal Survey Analysis in Lymphoma Survivors	N/A
Terminated	`NCT01239173` - Emotional Memory Reactivation in Posttraumatic Stress Disorder	Phase 3
Completed	`NCT02362477` - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD	Phase 3