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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02810197 Recruiting - Clinical trials for Post-Traumatic Stress Disorder

Resilience and Modification of Brain Control Network Following November 13

REMEMBER
Start date: June 2016
Phase: N/A
Study type: Interventional

This is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13 Paris terrorist attacks. Both structural and functional brain imaging data will be collected at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in control non-exposed participants. This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. This process is believed to be affected in Post-traumatic stress disorder (PTSD) which is characterized by anxiety and persistent intrusive memory of the traumatic event with highly distressing contents. This project will thus provide a unique opportunity to observe the online and structural dysfunctions of intrusion control network following a severe psychological trauma and how such process may contribute to recovery and psychopathological dynamics. In addition, the disruption of social cognition and emotional processing following PTSD will also be investigated in relation to disrupted inhibitory control functioning.

NCT ID: NCT02766192 Recruiting - PTSD Clinical Trials

TIMBER Psychotherapy and Ketamine Single Infusion in Chronic PTSD

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

Background: The poor prognosis and public health burden of PTSD necessitates the development of more effective and broader treatment approaches. In the etiopathogenesis of PTSD, trauma memories become ingrained into key brain areas through conditioned learning and are triggered by various situations of daily life. The brain glutamate system plays a key role in the process of trauma learning and trauma memories via long-term potentiation. Ketamine administration modulates the glutamate system and has been used in the treatment of depression and PTSD. Previous studies demonstrate that a single low dose of ketamine rapidly improves symptoms of refractory PTSD and treatment resistant depression. Unfortunately the observed response is short-lived (4-7 days, maximum up to 2 weeks) and multiple doses often produce unacceptable side effects. TIMBER (Trauma Interventions using Mindfulness Based Extinction and Reconsolidation for trauma memory) psychotherapy, is a manualized and translational mindfulness based cognitive behavioral therapy specifically designed to target trauma memories and their expressions in PTSD patients. The placebo controlled pilot study examined the efficacy of a protocol combining a single infusion of low dose ketamine (0.5mg/kg) and TIMBER psychotherapy in subjects suffering from chronic PTSD. The objective of this pilot study was to optimize and individualize treatment of chronic PTSD using a rapid, effective, trauma specific, user friendly and inexpensive approach that uses cutting edge psychopharmacological combined with novel psychotherapeutic approaches. Methodology: The randomized, double blind, placebo-controlled pilot study used a crossover design. Ten subjects with refractory PTSD were assigned to one of two arms: one arm (n=5) received combined ketamine infusion and TIMBER therapy (TIMBER-K arm) and the second (n=5) received combined placebo (normal saline) infusion and TIMBER therapy (TIMBER-P arm). All 10 subjects received a short version of TIMBER therapy after 10 minutes of onset of the infusion in which reactivation of trauma memories was initiated in a controlled manner using standardized scales and scripted narrative of the index trauma. This was followed by a standardized mindfulness based cognitive therapy module to quickly de-escalate the arousal symptoms followed by induction of detached observation and reappraisal of the trauma experience. After completion of the 40-min infusion, all subjects were trained on the full version of TIMBER therapy using methods of mindfulness based graded exposure therapy and a twice-daily schedule of home practice was initiated. The investigators are currently in a process of recruiting fifty more subjects to examine the effects in a larger sample.

NCT ID: NCT02734602 Recruiting - Clinical trials for Major Depressive Disorder

Imaging SV2A in Mood Disorders

Start date: April 2016
Phase: N/A
Study type: Interventional

This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses synaptic loss to determine whether ketamine administration could restore some of the structural changes associated with depression and PTSD. After a screening process to determine eligibility, all subjects will participate in an MRI, and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing and a stress test may also be done on scan days.

NCT ID: NCT02727972 Recruiting - Clinical trials for Major Depressive Disorder

Examination of Glutamate and mGluR5 in Psychiatric Disorders

Start date: August 2011
Phase: N/A
Study type: Interventional

This research study is designed to look at the involvement of the glutamate system in depression. Each subject will undergo a screening appointment to determine study eligibility. Thereafter, the study will take 2 or 3 visits depending on schedule availability and will consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing. Depending on camera time, staff availability and subject schedule, total study participation may last 1-2 months.

NCT ID: NCT02542709 Recruiting - Clinical trials for Post-traumatic Stress Disorder

The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder

Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.

NCT ID: NCT02512445 Recruiting - Clinical trials for Post-traumatic Stress Disorders

Trauma Informed Guilt Reduction Therapy

TrIGR
Start date: October 2015
Phase: N/A
Study type: Interventional

The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.

NCT ID: NCT02458521 Recruiting - Clinical trials for Traumatic Brain Injury

Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD

Start date: August 2015
Phase: N/A
Study type: Interventional

The overall objective of this project is to determine the efficacy and tolerability of TMS for mild Traumatic Brain Injury (mTBI) with PTSD symptoms and correlate treatment response with anatomical and biological factors unique to each service member (SM). Exploratory work will be done to look at the neuronal and biological changes that may occur over the course of TMS treatment.

NCT ID: NCT02443636 Recruiting - Depression Clinical Trials

The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Registry

Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

While effective interventions for depression exist, their success rates are unsatisfactory and their provision is haphazard. The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of outcomes for youths, adults and seniors with depression across the Maritimes. The investigators will establish an integrated system of assessment, treatment, research and education related to depression with the active involvement of those with lived experience. The establishment of a patient registry is a key step that will facilitate evaluation and reform of current services, integration of patient choice and community resources into treatment programs, monitoring long-term outcomes, and development of more effective treatment approaches through research. The registry will facilitate research that will include validation of new diagnostic and outcome measurement tools, low-cost clinical trials and collaborative projects with national and international partners. Educational programs will involve training the next generation of researchers, those with lived experience, clinicians, and health system managers in critical appraisal and will facilitate their involvement in research. The registry, the proposed systematic measurement of outcomes and the broad dissemination of information and skills will improve the quality of research and of care as well as the experience of patients and their families. The need for a registry: It is increasingly recognized that major advances in the treatment of mental disorders will require large scale clinical research. Recently demonstrated ways of completing large-scale research with finite resources include the routine use of electronic health records (EHR), data linkage and randomized registry trial. Use of EHR is the most efficient way of rapidly obtaining large amounts of information. However, EHR cannot completely exclude confounding by indication and other unmeasured variables. Therefore, tests of treatment effects require experimental designs that cannot be replaced by routine health records data. The gold standard for testing the effects of treatment in an unbiased way is the randomized controlled trial (RCT), where measured and unmeasured confounders are balanced through the randomization process and any remaining confounding is due to chance alone. RCTs are valued as the highest level of evidence, but are costly and take significant time to be completed, partly because of the need to screen a large group of individuals to identify eligible participants. The most efficient unbiased test of interventions, new treatment modalities and novel ways of treatment delivery is a method that combines EHR use with the randomized controlled trial (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a registry of individuals with available information to identify a large number of individuals suitable for an RCT. The RRT approach is efficient especially if the same information (e.g. diagnosis and treatment history) is used repeatedly for different purposes. The same information can be used for clinical purposes, service improvement and multiple research projects. RRT will allow obtaining answers about the efficacy of new treatments and management strategies significantly faster and at a much lower cost than traditional RCTs. Therefore, the investigators propose to establish a registry that has the capacity to conduct RRTs. The proposed registry will be integrated with similar efforts across Canada. Jointly, this collaborative network of registries will facilitate fast and economical testing of new treatments, which is urgently needed to advance the therapeutic options for people with depression and related conditions.

NCT ID: NCT02299583 Recruiting - Depression Clinical Trials

Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events

Start date: October 2014
Phase: N/A
Study type: Interventional

Background: International studies have shown that a substantial number of children and adolescents are exposed to potentially traumatic events. Many of these children and adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted to health care departments shortly after exposure as the most common types of traumatic events are accidental injury, serious somatic illness or death of someone close. There has been some research on early psychological interventions for prevention and treatment of PTSD. However, very little research has examined the efficacy of trauma-informed practice among health care professionals (HCPs). The present trial aims to evaluate and compare trauma-informed health care with usual practice. Methods/Design: The primary clinical question under investigation is the efficacy of an early, trauma-informed intervention for the prevention of PTSD in children and adolescents following exposure to a potentially traumatic event. The trail compares a standardized trauma-informed practice with usual care (no intervention) in health care departments receiving children and adolescents after exposure to determine if trauma-informed care is associated with a reduction in psychological outcome measures over time. Specifically, the investigators examine the efficacy of health care professional's active use of trauma-informed standards of action and a trauma training program for HCPs in the intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive symptoms on self-reports in the active intervention compared to usual care. Discussion: This trial will be the first controlled trial to examine a trauma-informed intervention carried out by HCPs. It will provide the first evidence on the efficacy of health care delivered by trauma-educated HCPs using trauma-informed standards of action. A successful implementation of this protocol will support the thesis that prevention of PTSD among children and adolescents benefits from a focus on the practice of HCPs. If efficacious, the results will be a call for future research to extend the investigation of interventions from psychological treatment to HCP-based care.

NCT ID: NCT02293291 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Thermal Clinic Treatment in Gulf War Illness

TCTGWI
Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Although thermal therapy has been utilized in the rehabilitation of war veterans since the Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This due to the fact that nobody knows that the cure for the syndrome in GWI veterans may exist in thermal therapy which is the primary objective of this investigation.