Pimavanserin for Moral Injury

3
Effectiveness
3
Safety
Michael E. DeBakey VA Medical Center, Houston, TX
Moral Injury+5 More
Pimavanserin - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Moral Injury

Study Summary

This study is evaluating whether a drug called pimavanserin may help improve sleep quality for veterans with posttraumatic stress disorder.

See full description

Eligible Conditions

  • Moral Injury
  • Stress Disorders, Post-Traumatic
  • Sleeplessness
  • Stress Disorders, Traumatic
  • Disease
  • Sleep Initiation and Maintenance Disorders
  • Post Traumatic Stress Disorder (PTSD)
  • Insomnia Chronic

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Pimavanserin will improve 2 primary outcomes and 3 secondary outcomes in patients with Moral Injury. Measurement will happen over the course of 6 weeks.

12 months
Completion rates of key outcome measures
Discontinuation rates due to adverse effects
Retention rates
6 weeks
Mean change in duration of stage N3 sleep pre- and post-treatment
7 months
Recruitment rates

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Pimavanserin
Somnolence
7%
Headache
7%
Insomnia
5%
Hallucination auditory
1%
Suicidal ideation
1%
Schizophrenia
1%
Self-injurious ideation
0%
Psychotic symptom
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02970292) in the Pimavanserin ARM group. Side effects include: Somnolence with 7%, Headache with 7%, Insomnia with 5%, Hallucination auditory with 1%, Suicidal ideation with 1%.

Trial Design

2 Treatment Groups

Control
open-label pimavanserin 34mg at bedtime for 6 weeks

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pimavanserin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

open-label pimavanserin 34mg at bedtime for 6 weeks
Drug
Subjects enrolled into treatment with open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
M. J.
Prof. Melissa Jones, Assistant Professor
Baylor College of Medicine

Closest Location

Michael E. DeBakey VA Medical Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
(irritability, fatigue, difficulty concentrating, and/or poor performance at work or school) The individual meets DSM-5 standards for chronic insomnia disorder if they have difficulty falling asleep (subjective sleep onset latency ≥30 minutes), difficulty staying asleep (subjective time awake after sleep onset ≥30 minutes), and/or awakening earlier in the morning (≥30 minutes before scheduled wake time and before a total sleep time of 6.5 hours) than desired at least three times a week and the insomnia complaint has been present for at least three months show original
The individual is determined to meet the criteria for current posttraumatic stress disorder according to the Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) and a total score of ≥33 on the PTSD Checklist (PCL-5). show original
The patient has moderate insomnia if their Insomnia Severity Index (ISI) total score is ≥ 15. show original
Male and female Veterans, aged 18-64
Willing and able to comply with all aspects of the protocol
The subject is willing to not start a concurrent behavioral or other treatment program for insomnia, PTSD, or other psychiatric disorders during the participation in the study. show original
If female subjects nor their partners are surgically sterile, and if they are not post- menopausal (absence of menses for at least 12 months), female subjects are considered to be of child-bearing potential. It is required that women of child-bearing potential who are sexually active agree to either refrain from sexual activity or use a two methods of contraception for the duration of the study (i.e., beginning 30 days prior to drug initiation and extending to 30 days after the last dose of study drug). The two methods should include: 1) A barrier method (e.g., condom with spermicidal gel, diaphragm with spermicide, intrauterine devices, cervical cap), and 2) One other method, including hormonal contraceptives (e.g., oral contraceptives, injectable contraceptives, contraceptive implant) or another barrier method.

Patient Q&A Section

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

What causes moral injury?

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Moral injury is the most commonly reported injury type in the context of medical emergencies, yet it is a relatively underreported phenomenon. The study shows that moral injury is not a trivial or unusual consequence of medical emergencies and offers some ways to help clinicians detect moral injury.

Unverified Answer

How many people get moral injury a year in the United States?

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The American Psychological Association has defined moral injury as a psychological term of mental distress as severe as physical illness, or a debilitating experience that negatively affects an individual's life. In an effort to understand one's mental health and encourage health promotion, the American Psychological Association's Task Force on Psychological Injury in America has described, “Moral injury is an injury that results from an event or experience in which the person is judged to do something morally wrong. Moral injury can be a long term disability.” The American Psychological Association estimates that moral injury costs the US U.S. economy $32.7 billion each year, in medical costs and lost productivity.

Unverified Answer

What are common treatments for moral injury?

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Therapists should be trained to address the core needs of victims of moral injury, including social support, safety, and justice. There is no one treatment that will fit all circumstances for all individuals, but therapists should know that moral injuries can disrupt interpersonal and family functioning, interfere with employment, and lead adolescents to substance abuse. Treatment should be individualized based on client's needs and history. Cognitive behavioral therapy (CBT) is a useful tool for addressing moral injury, with particular support to survivors who suffer moral injuries in professional. CBT can be delivered effectively by an experienced therapist and in a group setting.

Unverified Answer

Can moral injury be cured?

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Moral injury is usually associated with depression. A course of counselling has resulted in a statistically significant decrease in moral injury scores by half. Given the high prevalence of moral injury in this cohort, it can be concluded that counselling is worthwhile and can be beneficial to patients with depression.

Unverified Answer

What is moral injury?

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Moral injury is a term that has recently (in 2006) been adopted in the public health field. Although the term has been extensively used to describe psychological trauma in former prisoners of war in North Korean and former Soviet prisons, very little mention of it has been made in the international literature regarding war casualties. The definition of moral injury is a challenge for medical doctors. The core of moral injury is the experience of having been victimized by another's acts, and of having experienced shame or humiliation as a result of that experience. moral injury is frequently reported by patients (in more than 70 percent of cases of military personnel) as causal for their problems. Implications for the prevention and treatment of PTSD are discussed.

Unverified Answer

What are the signs of moral injury?

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The presence of a moral injury means that a person is in deep crisis; they are facing the loss of their sense of self or an unbearable loss of hope and of hope. To a lesser degree, these losses lead to difficulties with the responsibilities that come with living in a dynamic society. The presence of a moral injury is a marker for major crises in life in a person's life.

Unverified Answer

What is pimavanserin?

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Pimavanserin is the first oral tetradecapeptide antipsychotic to have been approved in the US or Europe. Preliminary data suggest pimavanserin may increase risk of death in those with dementia, and cause lower mood and irritability in those with depressive and anxiety disorders.

Unverified Answer

Does pimavanserin improve quality of life for those with moral injury?

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We found pimavanserin to be well tolerated. We found there to be significant benefit for patient-reported quality of life among individuals with MI. Copyright © 2016 John Wiley & Sons, Ltd.

Unverified Answer

How does pimavanserin work?

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Findings from a recent study demonstrate that pimavanserin is efficacious in ameliorating social and personal distress as well as functioning in both male and female subjects.

Unverified Answer

What are the latest developments in pimavanserin for therapeutic use?

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The PAMC was granted orphan drug designation status by the US FDA for the treatment of dementia associated with Alzheimer's disease and for Lewy body Dementia (LBD) and was approved in March 2006. In 2007 the Medicines and Healthcare products Regulatory Agency (MHRA) granted an update of designation from LBD to Alzheimer's Disease. The PAMC has been approved for marketing and sale throughout the European Union under the following brand names: PAMC Hoechst Marion Roussel, PAMC Bayer-Roussel, and PAMC Generics Ltd.

Unverified Answer

What is the average age someone gets moral injury?

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The age of the person who is harmed or the age at which the injury occurred did not necessarily influence perceptions of moral injury severity or perceived responsibility for the injury.

Unverified Answer
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