Suvorexant for Moral Injury
This study is evaluating whether a drug which reduces the amount of a chemical in the brain may help improve sleep and PTSD symptoms in Veterans. summary:
See full descriptionAbout the trial for Moral Injury
Treatment Groups
This trial involves 2 different treatments. Suvorexant is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
About The Treatment
Side Effect Profile for Drug
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Suvorexant will improve 2 primary outcomes, 2 secondary outcomes, and 1 other outcome in patients with Moral Injury. Measurement will happen over the course of Change in PTSD-related nightmares across the 12 week trial.
Patient Q & A Section
Can moral injury be cured?
The incidence of physical injury, in particular to health systems, is growing. The financial cost to the Australian public health system does significant harm. Given the potential for improving public health via the management of moral injury, it is of considerable fiscal and public health importance to minimise its occurrence by providing appropriate and effective support by which it can be prevented and managed. Preventive efforts to reduce morally injurious responses may be an effective way of mitigating the financial, ethical, and societal burden of moral injury.
What is moral injury?
Moral injury, as defined in this study, is an injury to the person that creates or exacerbates suffering of others. This is not limited to physical damage of the person but also the emotional hurt of the person and a loss of the person's sense of being part of a moral community. Moral injury, if not recognized, can lead to depression, anxiety, or even suicide.
What are common treatments for moral injury?
Moral injury is frequently treated with treatment as usual (TAU). More research is needed to define the best approach to treatment for moral injury in the chronic phase. Therapeutic [alli](https://www.withpower.com/clinical-trials/alli)ance can be improved for those suffering from moral injury if TAU is provided in therapy. Moral injury should be treated with psychoeducation, therapeutic alliance, and supportive psychotherapy and counseling. Treatment should be individualized with all patients receiving therapy.
What are the signs of moral injury?
Moral injury can be a major symptom of many internalizing disorders. A comprehensive assessment of the spiritual, emotional, and behavioral aspects of every patient's life may reveal signs of moral injury. In cases in which symptoms do not disappear with psychiatric intervention, the psychiatric team must consider the possibility of moral injury.
How many people get moral injury a year in the United States?
About 4.2 million adults in the United States are current victims of moral injury in a given year. Moral injury, a growing health problem, may be more common than reported, and patients should be encouraged to ask questions to their physician about moral injury.
What causes moral injury?
[The researchers concluded that the most important aspects of moral injury to study were the concept of self-esteem and the notion of the moral injury that results from the failure of the moral values that define us as a nation.
Is suvorexant typically used in combination with any other treatments?
There is evidence for the use of multiple agents to treat insomnia, and suvorexant is typically used in combination with drugs thought to be of low risk for serious drug interactions. However, suvorexant is rarely used alone. This may signify an area in which to further study is needed. Further research on the use of multiple agents to treat insomnia is needed.
How serious can moral injury be?
Current recommendations are for 'just look' procedures. This is supported by the low frequency of moral injury following standard clinical practice when compared with other clinical events such as adverse drug reactions, death, trauma related and malpractice claims. However, the frequency and complexity of the ethical situation is not well understood. Consideration of the potential harms and benefits of different interventions for determining a 'just look' approach or a 'good look' is needed.
Has suvorexant proven to be more effective than a placebo?
Suvorexant was more effective than a placebo for insomnia and sleepiness in the short-term treatment of insomnia as assessed by subjective self-rating scores (SPSEQ). ClinicalTrials.gov Identifier: NCT02015765.
Who should consider clinical trials for moral injury?
The most frequently cited ethical concerns about clinical trials are the desire to minimize suffering, the protection of the participant's autonomy, the potential for improper disclosure or deception of the investigator, respect for the investigator and/or the participant, and respect for the moral integrity of the trial. Given the variety of ethical concerns that have been reported by participants, researchers, and evaluators of clinical trials, and this analysis reinforces the need to ensure the integrity and safety of clinical trials and for evaluating the ethical considerations that surround their conduct.
Does suvorexant improve quality of life for those with moral injury?
It appears that QOL for individuals with moral injuries is significantly improved by using suvorexant. Given the poor outcomes of patients with moral injuries, it is imperative that research be performed to discover more effective treatments. Moreover, patients with moral injuries and comorbid psychiatric conditions should be offered treatment, including antidepressants or other psychotropic drugs.
What are the latest developments in suvorexant for therapeutic use?
Suvorexant is effective in reducing the severity of postoperatively sleep interrupted nighttime awakenings. Results from a recent clinical trial require confirmation in larger trials that include data from people with other sleep disorders and other neurologic or medical conditions such as neurological disorders.