N-acetylcysteine (NAC) for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Maryland Psychiatric Research Center (MPRC) ; the Treatment Research Program (TRP), Catonsville, MD
Schizophrenia+4 More
N-acetylcysteine (NAC) - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia

See full description

Eligible Conditions

  • Schizophrenia
  • Schizophreniform Disorders
  • Schizoaffective Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether N-acetylcysteine (NAC) will improve 5 primary outcomes and 4 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of The measure will be collected at baseline..

Hour 3
Electrophysiological measure
Medial prefrontal cortex glutamate levels using magnetic resonance spectroscopy (MRS)
Medial prefrontal cortex glutathione metabolite levels using magnetic resonance spectroscopy (MRS)
Whole brain gray matter and frontal gray matter cerebral blood flow (CBF)
Hour 7
Kynurenic acid levels
Serum kynurenine levels
Hour 5
Improvement in cognitive function
The measure will be collected at baseline.
Peripheral Blood Mononuclear Cell (PBMC) kynurenine 3-monooxygenase (KMO) activity
Serum kynurenic acid (KYNA) level

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

N-acetylcysteine & Tryptophan
1 of 2
Placebo & Tryptophan
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. N-acetylcysteine (NAC) 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 1 & 2 and have already been tested with other people.

N-acetylcysteine & TryptophanN-acetylcysteine 140 mg/kg up to a maximum of 15 g. Thirty minutes after N-acetylcysteine administration participants will receive Tryptophan, 6 grams.
Placebo & TryptophanPlacebo 140 mg/kg up to a maximum of 15 g. Thirty minutes after placebo administration participants will receive Tryptophan, 6 grams.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcysteine
FDA approved
Tryptophan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline after 3 hours on each challenge day.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline after 3 hours on each challenge day. for reporting.

Who is running the study

Principal Investigator
R. B.
Robert Buchanan, Principal Investigator
University of Maryland, Baltimore

Closest Location

Maryland Psychiatric Research Center (MPRC) ; the Treatment Research Program (TRP) - Catonsville, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Males and females
Age: 18 to 55 years
DSM-5 Criteria for schizophrenia, schizoaffective disorder or schizophreniform disorder (documented by SCID)
Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first or second generation antipsychotics permitted)
Female participants must agree to use a medically accepted means of contraception

Patient Q&A Section

What are the signs of schizophrenia?

"Persistent negative symptoms and deficits in cognition and social abilities are key components of schizophrenia. Schizoaffective disorder is a diagnostic and therapeutic entity which can often co-occur with schizophrenia and may be part of the clinical picture." - Anonymous Online Contributor

Unverified Answer

Can schizophrenia be cured?

"The question of whether schizophrenic patients can have their symptoms completely suppressed is difficult to answer. The current research has limitations because the results are inconsistent, the control was non-blind and the research included only schizophrenic mothers, with very few studies in men, for whom the results might have been much less convincing. However, the current research has shown that schizophrenia can, in some cases, be cured using antipsychotic medication." - Anonymous Online Contributor

Unverified Answer

What are common treatments for schizophrenia?

"The treatments of schizophrenia rely upon the diagnosis of schizophrenia and are therefore highly variable. Common treatments vary from group psychoeducational support to medication and antipsychotic treatment. Despite this, there is some consistency, with a general focus on anti-psychotic medication." - Anonymous Online Contributor

Unverified Answer

What is schizophrenia?

"It is clear that all the commonalities between schizophrenia and anxiety disorders are due to overlapping genetic risk factors. We suggest that a better clinical picture can be achieved by considering how common the common risk factors might be in each disorder. These common risk factors would include: dysfunctions of dopamine and glutamate networks. This article is based on the report of the Fourth International Conference on Schizophrenia held in Beijing, China, 21–26 November 2012. This report is available on the Internet at http://ejournal.sjo.org/content/2013/01/00/article.epfnr.13.en.page/ejournal/10/S01504013413011291." - Anonymous Online Contributor

Unverified Answer

How many people get schizophrenia a year in the United States?

"Between 0 and 5 persons may be affected by schizophrenia a year and between 0 and 100 persons may have been in contact with a diagnosable case of schizophrenia in the previous year. Persons in long-term care facilities or inpatient wards are more than 2-fold more likely to be affected by schizophrenia in a year than their overall counterparts." - Anonymous Online Contributor

Unverified Answer

What causes schizophrenia?

"Schizophrenia should be understood as a complex disease that is multifactorial in its nature. Many factors, most of which are unknown, may contribute to the emergence of schizophrenia." - Anonymous Online Contributor

Unverified Answer

Does schizophrenia run in families?

"The odds of any close relative of a patient having the disease increased as family size was increased. The authors concluded that environmental risk factors are likely, but no genetic/genetic linkage evidence was found. The high correlation of schizophrenia family history in families from Central and Southern Italy makes it the main area of interest for a genetic linkage scan in future genetic studies." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets schizophrenia?

"“At one end (mean 42) one estimate of average onset is 42 years for schizophrenia; some of the highest figures come from reports in the late 19th century of early-onset disorders from the first half of the 20th century, particularly in Scandinavia”. From late 2011 to mid 2014, the first world-wide study of schizophrenia onset conducted by a global partnership of experts from the World Health Organisation (WHO,) the World Bank, the U.S. National Institute of Mental Health, the University of Pittsburgh, and the University of Toronto, projected that the lifetime prevalence of schizophrenia spectrum disorders (including major depressive disorder, bipolar disorder, and first episode psychosis) jumped from 9.8% in 1990 to 12." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in n-acetylcysteine (nac) for therapeutic use?

"NAC is well tolerated and shows promise in the treatment of a range of N-acetyl-DL-serine-esterase inhibitors (NAESTIs) and is currently undergoing clinical trials for the treatment of schizophrenia." - Anonymous Online Contributor

Unverified Answer

Has n-acetylcysteine (nac) proven to be more effective than a placebo?

"Significant decreases in symptoms were observed when nac was used as add-on therapy to olanzapine in schizophrenia patients. This trial was stopped early because of elevated alanine aminotransferase levels in the nac vs the placebo group." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving n-acetylcysteine (nac)?

"A small trial to date has shown nac has a trend to be beneficial for schizophrenia and psychosis; however, further research seems necessary before it can be recommended. Further trials could add to the current evidence by providing additional evidence for the potential clinical benefits of nac in other psychotic disorders." - Anonymous Online Contributor

Unverified Answer

Is n-acetylcysteine (nac) typically used in combination with any other treatments?

"Nac is typically used in combination with any other treatments and can be used alone. For patients with severe delusions or hallucinations, a combination with risperidone can be considered." - 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.
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