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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT01987960 Terminated - PTSD Clinical Trials

Brexpiprazole as an Additional Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

Start date: December 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine or sertraline on PTSD symptoms.

NCT ID: NCT01958593 Terminated - Clinical trials for Posttraumatic Stress Disorder

Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

Start date: October 14, 2014
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA, or placebo, followed by a dose of 62.5 mg of MDMA, or placebo. During this treatment period, participants will also undergo non-drug preparatory therapy sessions and non-drug integration sessions. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period. Safety measures will also be assessed between groups.

NCT ID: NCT01939210 Terminated - Depression Clinical Trials

Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy

Start date: February 2010
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies the effects of meditation-based breathing training on patients' control of their breathing patterns and breathing-related movement, as well as on their psychological distress and treatment experience during radiation therapy. Meditation-based breathing training may decrease breathing-related movement and the amount of stress by improving breathing patterns in patients with abdominal or lung cancer undergoing radiation therapy.

NCT ID: NCT01920451 Terminated - Hypertension Clinical Trials

Blood Pressure, Heart Rate Variability & Sleep in Veterans With PTSD

Start date: August 2013
Phase: N/A
Study type: Interventional

Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in returning Veterans, and both conditions are known to increase the risk of cardiovascular disease. Research suggests that those with insomnia are at triple the risk of high blood pressure as compared to normal sleepers, and that having both insomnia and short sleep increases this risk to more than five times that of normal sleepers. These research findings suggest that recently deployed Veterans with insomnia may be at increased risk of developing high blood pressure, and this possibility is consistent with previous research. Vietnam era Veterans with combat-related PTSD assessed in 1985 were twice as likely to have died of early-onset heart disease relative to their non-PTSD counterparts when reassessed in 2000. Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across several studies as well. Compared to individuals without PTSD, those with PTSD seem to have lesser reaction to stress in terms of both heart rate and heart beat pattern. However, there has been very little research examining the impact of behavioral sleep interventions on health outcomes, and even fewer that are specific to a PTSD or Veteran population. The purpose of this study is to determine if treating insomnia results in improved blood pressure and cardiac function in recently deployed Veterans with PTSD. The findings of this research will serve as pilot data for a future grant application testing the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBTI) for reducing cardiovascular risk in Veterans with PTSD using a full-scale randomized trial design. We are hypothesizing that improved sleep will be significantly associated with improved blood pressure and increased heart rate variability (improved autonomic function) in adults receiving CBTI compared to those in a wait-list control condition.

NCT ID: NCT01917318 Terminated - Clinical trials for Post Traumatic Stress Disorder

Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.

NCT ID: NCT01781247 Terminated - Clinical trials for Myocardial Infarction

Myocardial Infarction - Stress Prevention Intervention

MI-SPRINT
Start date: January 2013
Phase: N/A
Study type: Interventional

Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the traumatic experience of myocardial infarction (MI). PTSD is associated with impaired quality of life, social functioning, and high economic burden to the society. Posttraumatic stress attributable to MI has also been shown to be predictive of poor cardiovascular prognosis, whereby this link might relate to several atherothrombotic processes. Therefore the prevention of PTSD after MI is of high relevance. Guidelines have been published for early interventions to prevent the development of posttraumatic stress after different types of trauma but not in terms of acute MI as a traumatic event. The overarching aim of the planned trial is to test whether a minimal behavioral intervention performed shortly after acute MI in patients at a high risk to develop PTSD and in the setting of a coronary care unit reduces the development of posttraumatic stress. The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be at least 20% lower in the intervention group than in the control group, and that this effect will last up to 12 months after the intervention. The secondary hypothesis is that the intervention group will show better psychosocial functioning, and a more favourable cardiometabolic biomarker profile than the control group 3 and 12 month after the intervention.

NCT ID: NCT01650220 Terminated - Clinical trials for Cardiovascular Disease

Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

CVMarkers
Start date: April 2012
Phase: N/A
Study type: Observational

This is an observational study designed to determine whether veterans with PTSD have a higher risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by interview and review of medical records, carotid artery ultrasound, and blood tests measuring markers of inflammation. Study participation is approximately 6 months. The eligible study population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), age 28 through 38 years.

NCT ID: NCT01626131 Terminated - Clinical trials for Post-Traumatic Stress Disorder

Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

Start date: October 2011
Phase: Phase 2
Study type: Interventional

The primary objective of this pilot intervention study is to examine the efficacy of exercise for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD (N = 40). Participants will be randomly assigned to one of two groups. Participants in the exercise training group (n = 20) will receive three 60-75 minute sessions per week of combination aerobic and resistance training for eight weeks. In the control stretching group, participants (n = 20) will receive training in whole-body flexibility three times per week for eight weeks. Secondary objectives include 1) determining feasibility of the intervention (as measured by the percentage of prescribed days of exercise completed by each participant, and percentage of time exercising completed at the prescribed intensity and duration); 2) determining the influence of exercise training on aerobic fitness and strength in the sample; and 3) determining whether psychiatric/somatic symptom improvements are associated with improvements in fitness and strength. Finally, exploratory objectives will include examining whether exercise training can improve early signs of heart disease, and whether certain biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment response.

NCT ID: NCT01574118 Terminated - Clinical trials for Chronic Posttraumatic Stress Disorder

Enhancing Exposure Therapy for Post-traumatic Stress Disorder

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.

NCT ID: NCT01555554 Terminated - Clinical trials for Post-traumatic Stress Disorder

Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)

Start date: May 2012
Phase: N/A
Study type: Interventional

Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system. Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations. This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes. The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.