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Post-Traumatic Stress Disorder clinical trials

View clinical trials related to Post-Traumatic Stress Disorder.

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NCT ID: NCT04152993 Recruiting - Clinical trials for Post-Traumatic Stress Disorder

Responsive Neurostimulation for Post-Traumatic Stress Disorder

Start date: March 22, 2021
Phase: Early Phase 1
Study type: Interventional

Post-traumatic stress disorder (PTSD) refractory to treatment is marked by failure of fear extinction and its biological substrate, amygdala reactivity to trauma reminders. Decades of research have clarified the neuronal mechanisms coordinating fear extinction and consolidation. Fear cells and extinction cells in the basolateral amygdala (BLA) alter their firing rate based on the nature of the stimulus and the influence from the medial prefrontal cortex (mPFC) and the ventral hippocampus (vHPC). Together, the BLA, mPFC, and the vHPC form an anxiety-processing network where the BLA links stimulus to emotion, the vHPC provides memory context, and the mPFC coordinates extinction or consolidation. Local field potential (LFP) recordings from the BLA have revealed specific signals that correspond to an enhanced fear state. Previous studies have shown that neuromodulation of the BLA can promote extinction in a rodent model and in a treatment-refractory PTSD patient. This action is likely carried by disrupting fear signals within the BLA; however, continuous neurostimulation may also disrupt normal function of the amygdala. The present application proposes to investigate the use of Responsive Neurostimulation (RNS, Neuropace) in six (6) veterans suffering from severe treatment-resistant PTSD. This dual-activity device will allow us to chronically record LFPs from the BLA under specific conditions such as fear conditioning, exposure to trauma reminders, and emotional memory encoding and retrieval. In addition, the neural activity will be captured during real-life symptoms of flashback and nightmares. These recordings will provide the specific electrophysiological biomarkers of hypervigilance and re-experiencing. The device will then be programmed to detect and treat these biomarkers with a pre-determined electrical pulse. The patients will be followed prospectively using psychological scales but also with functional neuroimaging and electroencephalograms. These modalities will be used to determine the extent of circuit engagement as a result of the therapy. By approaching PTSD from a fear processing mechanism perspective, our project will serve as a proof of concept for other circuit-based therapies in psychiatry. This proposal is a multi-departmental effort involving 11 investigators across 7 departments and requires a close collaboration between clinical and basic scientists. As a result, the findings underlying chronic recordings will bridge the basic science results from fear conditioning research to clinical neural processes in PTSD patients.

NCT ID: NCT04150380 Recruiting - Inflammation Clinical Trials

Probiotic (LGG) for Veterans With PTSD

Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with posttraumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic, Lactobacillus rhamnosus GG (LGG; ATCC53103), to treat chronic symptoms associated with PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by biomarkers of inflammation, gut microbiota composition, intestinal permeability, stress response, decision making, and PTSD symptoms, this study may identify a novel intervention for the treatment of symptoms associated with this frequently occurring condition.

NCT ID: NCT04070183 Recruiting - Depression Clinical Trials

POST Facilitation for Community Dwelling Older Adults (POST-RCT)

POST-RCT
Start date: May 11, 2020
Phase: N/A
Study type: Interventional

We propose to study the effects of Physician Orders for Scope of Treatment (POST) Facilitation in a randomized controlled trial in a population of community dwelling older adults who qualify for POLST facilitation, including those with normal cognition and those with Alzheimer's Disease and Related Disorders.

NCT ID: NCT03972410 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Eye Movement Desensitization and Reprocessing vs Supportive Expressive Dynamic Psychotherapy for Childbirth Trauma

Start date: January 8, 2020
Phase: N/A
Study type: Interventional

There is increasing evidence that about 30% of women evaluate their childbirth as traumatic and that women could develop post-traumatic stress disorder (PTSD) in response to events of birth. The mean prevalence of post-partum PTSD (PP-PTSD) was reported as 3-4% in community samples and 15.7-18.95% in high-risk samples. The primary aim is to investigate the effectiveness of Eye Movement Desesitization and Reprocessing (EMDR) in treating post-traumatic and postpartum depressive symptoms in women who had a traumatic childbirth as compared to Supportive Expressive Dynamic Psychotherapy (SEDP) as therapy as usual. Secondary outcomes are: - to evaluate the differences between EMDR and SEDP in preventing the onset of PTSD and Post-partum Depression after 3 months; - to evaluate the effectiveness of EMDR and SEDP on anxiety and mother-child bonding; The subjects of the study will be 60 women who had a traumatic childbirth in the previous 2 days. Women with a Impact of Event Scale-Revised (IES-R) score > or = to 24 will be treated with 2-4 sessions of EMDR or with SEDP. Two follow-up assessments will be scheduled: at 6-weeks post-partum (after the end of the psychotherapeutic intervention) and at 12-weeks post-partum.

NCT ID: NCT03944447 Recruiting - Depression Clinical Trials

Outcomes Mandate National Integration With Cannabis as Medicine

OMNI-Can
Start date: December 1, 2018
Phase: Phase 2
Study type: Interventional

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT ID: NCT03935035 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Online PTSD Treatment for Young People and Carers - Case Series

OPTYC
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments. The researchers are therefore developing a website and smart-phone App that will improve accessibility of this treatment by allowing trained therapists to deliver CT-PTSD over the internet (iCT) to young people (12-17 years old) with PTSD. This study aims to provide an initial evaluation of iCT. This will be done by running an uncontrolled case series with 6 young people. The objectives of the case series are to: to gauge acceptability of the programme to young people, carers, and therapists; to measure adherence to the programme; to test the battery of measures for acceptability; and to obtain estimates of clinical change.

NCT ID: NCT03932773 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.

NCT ID: NCT03907254 Recruiting - Clinical trials for Traumatic Brain Injury

Biopsychosocial Effect of Service Dog Training on Post-traumatic Stress (PTS) and Post Concussive Symptoms

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

Preliminary clinical evidence suggests that Service Members with symptoms of post-traumatic stress disorder (PTSD) or Post Traumatic Stress (PTS) who participate in the Service Dog Training Program (SDTP) report improved physical and psychological outcomes, including those with overlapping symptoms associated with traumatic brain injury (TBI) and post-concussion symptoms (PCS). This study intends to examine the psychological, social, and biological effects of learning how to train a future service dog combined with standard of care for individuals with symptoms of Post-Traumatic Stress (PTS), including those with overlapping TBI and persistent Post-Concussive Symptoms (PCS). Biological, social, and behavioral measures will be collected throughout study participation.

NCT ID: NCT03819608 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Start date: October 2020
Phase: N/A
Study type: Interventional

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI and PTSD.

NCT ID: NCT03667846 Recruiting - Clinical trials for Alcohol Use Disorder

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD

Start date: October 16, 2019
Phase: Phase 2
Study type: Interventional

This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.