Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after exposure to a dangerous or life-threatening event. It is characterized by persistent fear- and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt. These symptoms can interfere significantly with patients' lives and in some cases can be debilitating. One of the most frequent causes of PTSD is being a victim of a violent, interpersonal assault. PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded too strongly in a patient's long-term memory, remaining too accessible and "present" to the patient long after the actual threat has passed. In recent years evidence has emerged that it may be possible to prevent PTSD by moderating the process of memory consolidation that occurs in the hours and days after a traumatic event. Early research has suggested that enhancing the body's natural cortisol response to a stressful event may be a safe and effective way of moderating the process of memory consolidation and promoting adaptive, non-pathological memory encoding. In particular, the administration of hydrocortisone, a safe and widely used drug that mimics the body's own cortisol hormone, appears to reduce the risk of developing PTSD in patients who have sustained a traumatic event. However, this research is still in relatively early stages, and requires larger trials to confirm its efficacy. In addition, the research thus far has not adequately targeted assault victims, whom Investigator feel are some of the patients most likely to benefit from such an approach. Investigators propose a prospective, placebo-controlled, double-blinded trial of administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein Medical Center Philadelphia Emergency Department to determine if this approach has efficacy in preventing PTSD. This study is designed as a pilot study, with the hopes that the data gathered in it can be used to design a larger and more robust trial in the future.
NCT02402114 — Post-Traumatic Stress Disorder
Status: Withdrawn
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT02402114/
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder Concomitantly Treated With Prazosin
This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs. Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the response to placebo.
NCT02384369 — Stress Disorders, Post-Traumatic
Status: Not yet recruiting
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT02384369/
Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD
Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators hypothesize that patients receiving prazosin will have a greater reduction in suicidal ideation.
NCT02199652 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT02199652/
Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD)
Combat-related post traumatic stress disorder (PTSD) has become an increasingly pressing public health problem in the United States following the overseas wars of the last decade. Rates of PTSD have skyrocketed in the military and among veterans, leading to increased rates of suicide, impairment on the job and off, and behavioral changes that negatively affect not just the veteran, but also his or her family. Although effective medication and psychotherapy treatments exist for combat-related PTSD, many individuals suffering with PTSD do not adequately respond to currently available treatment options, highlighting the need to develop and test new interventions for the disorder. To address this pressing clinical issue, the investigators will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms in adults suffering from combat-related PTSD. The investigators plan to recruit a sample of 10 medically healthy individuals with combat-related PTSD who will receive a single session of WBH to determine if this single session improves PTSD symptoms and, if so, whether this improvement will last at least 2 weeks. To do this, the study will include basic clinical and psychiatric assessments immediately before and one and four weeks after WBH. Because sleep is so often impaired in PTSD, the investigators will measure at-home sleep patterns for a week prior to and a week following the WBH session using sleep diaries and a wristwatch actigraphy device. Given scientific evidence from our research group that WBH may improve depression, the investigators anticipate that it may also be of benefit or adults suffering from combat-related PTSD.
NCT02077972 — Post Traumatic Stress Disorder (PTSD)
Status: Terminated
http://inclinicaltrials.com/post-traumatic-stress-disorder-ptsd/NCT02077972/
Cranial Electrotherapy Stimulation (CES) to Treat PTSD: Identifying Metrics of Efficacy Using Brain Imaging
Use of the Fischer Wallace Cranial Stimulator to relieve symptoms related to PTSD.
NCT01860677 — Treatment of PTSD Symptoms
Status: Recruiting
http://inclinicaltrials.com/treatment-of-ptsd-symptoms/NCT01860677/
Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a highly prevalent anxiety disorder that is associated with an increased risk of cardiovascular (CV) disease and hypertension. One potential mechanism is overactivation of the sympathetic nervous system (SNS), both at rest and particularly during stress. This study will evaluate whether 8 weeks of daily DGB therapy or transcutaneous vagus nerve stimulation (tVNS) therapy improves SNS activity at rest and during stress.
NCT01627301 — Post-traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT01627301/
Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims
Veterans can apply for compensation and pension (C & P) benefits for a disability related to military service. The application exam for these benefits provides an opportunity for Veterans returning from service to access VA care. The investigators will recruit Veterans applying for C & P to participate in this study. All enrolled participants will complete questionnaires around the time of their C & P exam related to substance abuse, PTSD, service use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment over time, and examine whether C & P award, substance use, and beliefs about benefits are related to treatment attendance. Some enrolled participants will be assigned to one of two study groups: a treatment group and a no-additional-treatment group. People assigned to these groups will complete the same substance abuse, PTSD, service use, and attitudes questionnaires two additional times during the study. Participants assigned to the treatment group will receive information about the relationship between substance use and PTSD and will be referred to relevant treatment. The investigators will test whether Veterans who receive no-additional-treatment have different symptoms over time and attend less treatment sessions (mental health or substance abuse) than people assigned to treatment.
NCT01597856 — Attendance at Treatment
Status: Completed
http://inclinicaltrials.com/attendance-at-treatment/NCT01597856/
Improving PTSD Service Delivery for Veterans With Severe Mental Illness
As in the general population, there is no clear standard of care within Veterans Affairs Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among Veterans and this symptom presentation clearly exacerbates the overall course and severity of mental illness. This study is significant in that it proposes to establish the efficacy of a frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated that these data will establish a much needed clinical course of action for what is considered a vulnerable yet highly underserved patient population.
NCT01542229 — Schizophrenia
Status: Completed
http://inclinicaltrials.com/schizophrenia/NCT01542229/
The Effect of Nasal Continuous Positive Airway Pressure (Nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.
We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use alcohol to control their symptoms).
NCT01512771 — Anxiety
Status: Completed
http://inclinicaltrials.com/anxiety/NCT01512771/
Computerized Tailored Intervention for Behavioral Sequelae of Post-Traumatic Stress Disorder in Veterans
This project assesses the usability and feasibility of a multi-behavioral computerized, tailored intervention (CTI) or expert system delivered via the Internet for veterans with Post-Traumatic Stress symptoms. Three behavioral health risk factors, (1) smoking, (2) depression, and (3) stress, that are associated with Post-Traumatic Stress Disorder (PTSD), are included in the Computerized, Tailored Intervention (CTI) system. The project adapts and modifies an existing CTI system built on the Transtheoretical Model of Behavior Change (TTM) to make it relevant to a veteran population. The system has been successfully utilized with general adult populations. The study utilizes methods that are characteristic of a product development project. Each of the four project phases are sequential and build upon the results of the previous phase. Phase 1 focuses on the review of current CTI programs on smoking cessation, stress management, and depression prevention, and integrating them into a multi-behavioral program for application with veterans. Phase 2 includes the development and adaptation of text-based feedback messages and multimedia components for smoking cessation, stress management, and depression prevention for veterans. Initial testing of the modified CTI programs commences in Phase 3. Cognitive and usability testing with veterans are performed, and additional modifications to the behavioral modules are made based on the test results. Phase 4 focuses on a feasibility study to test the multi-behavioral CTI system with veterans online.
NCT01510834 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT01510834/