CLINICAL TRIAL

Suvorexant for Moral Injury

Recruiting · 18+ · All Sexes · Salisbury, NC

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 description

About the trial for Moral Injury

Eligible Conditions
Disease · Dyssomnias · Stress Disorders, Post-Traumatic · Parasomnias · Stress Disorders, Traumatic · Sleep Initiation and Maintenance Disorders · Post Traumatic Stress Disorder (PTSD)

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Suvorexant
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
FDA approved

Side Effect Profile for Drug

Drug
Show all side effects
0%
Fatigue
0%
Facial swelling
Fatigue
0%
Facial swelling
0%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT02491788) in the Drug ARM group. Side effects include: Fatigue with 0%, Facial swelling with 0%.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Insomnia indicated by an ISI score > 14
Sertraline
Men and Women, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide written informed consent
Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma
Chronic full syndromal PTSD diagnosis >3 months duration as indexed by CAPS-5 score >12 at screening
Paroxetine
Fluoxetine
Fluvoxamine
Citalopram
Escitalopram
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Change from 1 week at baseline, and weeks 4, 8, and 12
Screening: ~3 weeks
Treatment: Varies
Reporting: Change from 1 week at baseline, and weeks 4, 8, and 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from 1 week at baseline, and weeks 4, 8, and 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Pittsburgh Sleep Quality Index-PTSD Addendum (PSQI-A)
CHANGE IN PTSD-RELATED NIGHTMARES ACROSS THE 12 WEEK TRIAL
PSQI-A will be used to assess disruptive nocturnal behaviors related to PTSD, including nightmares, hot flashes and episodes of terror during sleep. Scores ranges from 0 (normal) to 21 (severe). The investigators plan to evaluate nightmares as a secondary outcome.
CHANGE IN PTSD-RELATED NIGHTMARES ACROSS THE 12 WEEK TRIAL
Insomnia Severity Index (ISI)
CHANGE FROM BASELINE TO WEEK 12
The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.
CHANGE FROM BASELINE TO WEEK 12
Clinical Global Impression (CGI)
CHANGE ACROSS THE 12 WEEK TRIAL
The Clinician and patient reports of improvement on the CGI (depression, mood, vigor, suicidality, daytime somnolence, and functional disability rating scales.) The CGI measures psychiatric treatment response by evaluating global severity of illness and change in the clinical condition over time. It consists of 3 global subscales: Severity of Illness, Global Improvement, and Efficacy Index. Item 1 is rated on a seven-point scale (1=normal to 7=extremely ill); item 2 on a seven-point scale (1=very much improved to 7=very much worse); and item 3 on a four-point scale (from 'none' to 'outweighs therapeutic effect'). The CGI will be used as a secondary measure of remission (i.e., CGI-I of 1 "very much improved" or 2 "much improved").
CHANGE ACROSS THE 12 WEEK TRIAL
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
CHANGE FROM BASELINE TO WEEK 12
The CAPS-5 is a 30-item interview that is the gold standard assessment for PTSD. The CAPS-5 provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score. The CAPS-5 will determine a threshold for PTSD severity (past week) at baseline (excluding change in item #20 falling and staying asleep). Possible scores range from 0 to 80. All trained and certified CAPS-raters will function independently and will not be involved in recruitment, study coordination, or evaluation of side effects.
CHANGE FROM BASELINE TO WEEK 12
Wrist Actigraphy
CHANGE FROM 1 WEEK AT BASELINE, AND WEEKS 4, 8, AND 12
Sleep wake schedule will be monitored with wrist actigraphy (Micro Motionlogger, Ambulatory Monitoring, Inc.). The actigraph provides continuous activity data using a battery-operated wristwatch-size microprocessor that senses motion with a three axis accelerometer. High-resolution data will be down-sampled to one-minute sample intervals for conventional actigraphic sleep-wake estimation and analyzed using ActionW-2 (Ambulatory Monitoring, Inc.) software. Sleep efficiency, sleep maintenance, total sleep time and wake after sleep onset will be used as secondary measures of sleep.
CHANGE FROM 1 WEEK AT BASELINE, AND WEEKS 4, 8, AND 12

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Moral Injury by sharing your contact details with the study coordinator.