N-acetyl cysteine for Suicide

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Minnesota, Minneapolis, MN
Suicide+3 More
N-acetyl cysteine - Drug
Eligibility
< 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether NAC may help reduce the severity of self-injury in adolescents and young adults.

See full description

Eligible Conditions

  • Suicide
  • Self-Harm
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Suicide

Study Objectives

This trial is evaluating whether N-acetyl cysteine will improve 1 primary outcome and 2 secondary outcomes in patients with Suicide. Measurement will happen over the course of 28 days.

28 days
Change in GSH reduced-to-oxidized ratio
Change in glutamate concentrations
Change in glutathione concentrations in ACC

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Suicide

Side Effects for

Treatment With N-Acetyl Cysteine
Pruritis
35%
Nausea
10%
This histogram enumerates side effects from a completed 2017 Phase 1 & 2 trial (NCT02206152) in the Treatment With N-Acetyl Cysteine ARM group. Side effects include: Pruritis with 35%, Nausea with 10%.

Trial Design

3 Treatment Groups

High-Dose NAC
1 of 3
Low-Dose NAC
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 43 total participants across 3 different treatment groups

This trial involves 3 different treatments. N-acetyl Cysteine is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

High-Dose NAC
Drug
5400 NAC mg/day
Low-Dose NAC
Drug
3600 NAC mg/day
Placebo
Drug
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cysteine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 28 days for reporting.

Closest Location

University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The ability to understand study procedures and to comply with them throughout the study. show original
≥ 5 episodes of self-injury that have caused damage to the skin, where there are visible signs of the injury. show original
This means that the dosage of the medication does not change for a month. show original
The current frequency of at least one NSSI episode in the past 2 months is 9.5%. show original

Patient Q&A Section

What are the signs of self-injurious behavior?

"Self-injurious behavior is often associated with multiple psychiatric diagnoses including depression, anxiety disorder, schizophrenia, antisocial personality disorder, personality disorder and personality disorders. It is likely that these diagnoses overlap in some clinical patterns or symptoms, but may have different causal factors, mechanisms and therapeutics. Thus, different assessment strategies and treatment considerations have been proposed or investigated." - Anonymous Online Contributor

Unverified Answer

Can self-injurious behavior be cured?

"Self-injurious behavior is an extremely difficult condition to treat. However, these self-injurious behaviors may be treated successfully with psychotherapy provided to the sufferer as well as close family members. We recommend that these techniques be systematically evaluated, replicated, and refined over time in an effort to ensure that all involved will derive benefit." - Anonymous Online Contributor

Unverified Answer

What are common treatments for self-injurious behavior?

"There is no single treatment approach that shows clinical effectiveness in all cases of self-injurious behavior. To get the most effective treatment, it is crucial to differentiate self-injurious behavior and self-harm." - Anonymous Online Contributor

Unverified Answer

What causes self-injurious behavior?

"Autistic behavior is characterized by the degree to which it deviates from typical social behavior. While some people are reluctant to use this diagnostic term, others find autism to be an essential feature of the disability. Both conditions are pervasive and debilitating to the individual and their family and close associates, and most of those affected seek treatment. In most cases, autism is due to a genetic disorder involving a malfunctioning genetic code, like fragile X syndrome, known to cause self-injurious behavior in both unaffected siblings and others. We conclude that self-injurious behavior is associated with genetic disorders such as fragile X syndrome; however, the exact extent of its association is not yet ascertained." - Anonymous Online Contributor

Unverified Answer

How many people get self-injurious behavior a year in the United States?

"Self-injurious behavior is not a new occurrence. Its prevalence remains a concern. When people get self-injurious behavior, they are usually individuals who live alone, often lack mental health services, have some psychiatric conditions, and are experiencing emotional disruption, including some instances of psychosis. Therefore, in addition to providing counseling, care providers and treatment providers should be aware of this behavior and provide referrals to other agencies." - Anonymous Online Contributor

Unverified Answer

What is self-injurious behavior?

"Given the many different terms and ways of describing self-injury, it is hard to establish a common definition of self-injury. Therefore, we do not use the term in our research. Rather, we use the term self-injurious behavior, which is part of a broader term that is used to describe the behaviors associated with self-injury. In summary, there is no consensus in the scientific literature as to what constitutes self-injurious behavior. That is true of self-injury generally, and especially when applied to children and adolescents. Our work is not intended to be the first examination of self-injurious behavior; rather, it seeks to describe the best research designs and methodology for studying this behavior." - Anonymous Online Contributor

Unverified Answer

Is n-acetyl cysteine safe for people?

"This is the first study to demonstrate safety and tolerability of NAC in a population with a high-risk of developing ALPS. The lack of evidence for a reduction in the risk of ALPS in this population suggests that the evidence supporting the efficacy of acetylcysteine in the prevention of this adverse cutaneous reaction is weak at present. Further randomized control studies are required to establish if this form of treatment is effective in preventing allergic reactions." - Anonymous Online Contributor

Unverified Answer

Is n-acetyl cysteine typically used in combination with any other treatments?

"The data from this study suggest that, in addition to any conventional psychiatric treatment that may also be necessary, n-acetyl cysteine may be a useful adjuvant treatment for obsessive-compulsive disorder. The mechanism by which n-acetyl cysteine may be useful in this context is unclear, but is consistent with the findings of some clinical studies indicating that it may be useful for treating other neuropsychiatric disorders and may reduce the extent to which some neuropsychiatric disorders persist after conventional treatment is discontinued." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in n-acetyl cysteine for therapeutic use?

"The only data available to evaluate safety and efficacy of NAC in children comes from one randomized clinical trial for the treatment of pediatric acute pancreatitis. Since this study was published the only report of a placebo-controlled, double-blind, randomized clinical trial of NAC for the adjunctive treatment of autistic spectrum disorders. In the past several years, NAC has also been used in studies of preclinical models of schizophrenia, neuropathic pain, and ischemia. All studies suggest that NAC is safe and effective as an aid in the treatment of these conditions." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of n-acetyl cysteine?

"NAC has been shown to be well tolerated in a number of human studies. The observed side effects are typical of an antiepileptic drug and are not serious. Most people who take NAC do not have symptomatic abnormalities. Rare side effects may include nausea, abdominal pain, and vomiting." - Anonymous Online Contributor

Unverified Answer

Has n-acetyl cysteine proven to be more effective than a placebo?

"NAC may have some beneficial effects in the treatment of self-injurious behavior. Further research is needed to prove its effectiveness, especially its effectiveness while taking acetylcholinesterase inhibitors as most patients with self-injury are also prescribed AChE inhibitors." - Anonymous Online Contributor

Unverified Answer

What does n-acetyl cysteine usually treat?

"A Cochrane review concluded that there was limited evidence to support NAC for the management of a burning sensation, itching, skin or mucous membrane irritation following dermal exposure, or pain from skin/mucous membrane injuries due to physical activity injury. No evidence was found supporting NAC for skin conditions that were not physical activity." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Suicide by sharing your contact details with the study coordinator.