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Trial record 41 of 580 for:    reduced glutathione

Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine (NAC2)

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ClinicalTrials.gov Identifier: NCT02505477
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Yvonne S. Yang, University of California, Los Angeles

Brief Summary:

The purpose of this study is to attempt to treat cognitive and negative symptoms of schizophrenia, with the nutritional supplement N-acetylcysteine (NAC).

Schizophrenia is a chronic mental disorder that affects approximately 65 million people worldwide, and causes significant disability and suffering. Patients with schizophrenia often hear voices and have persecutory delusions. Though these are the most recognizable features of the illness, the deficits most closely linked to disability are known as cognitive deficits and negative symptoms. Cognitive abilities refer to the ability to perform mental tasks that require focus and attention, and also include memory and verbal skills. Negative symptoms refer to a lack of interest in the world, and decreased social interactions. In our study, the investigators aim to improve these symptoms and deficits by targeting the glutamate system.

Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at others. As well, free radicals surrounding glutamate receptors also interfere with their proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement that may restore glutamate to its correct levels in the brain, and may also help protect the brain from antioxidant damage.

In our study, patients with schizophrenia will be randomly assigned to receive either NAC or placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione, will be measured before and after treatment, using a neuroimaging technique known as magnetic resonance spectroscopy. Cognitive and negative symptoms will also be assessed before, during and after treatment. The investigators hypothesize that glutamate and glutathione will be normalized in patients' brains, and that their negative and cognitive symptoms will be improved, too.


Condition or disease Intervention/treatment Phase
Schizophrenia Cognitive Deficits Schizophrenia; Negative Type Drug: N-acetylcysteine Other: Treatment as Usual Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms of Improving Cognition and Negative Symptoms in Schizophrenia With N-Acetylcysteine: a Magnetic Resonance Spectroscopy Study of Glutamate and Glutathione
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: N-acetylcysteine
Patients in this group will receive N-acetylcysteine (NAC) 1200mg orally twice daily (total daily dose 2400mg), for eight weeks. Each individual tablet contains 300mg NAC, therefore patients will take two tablets by mouth each morning and two tablets by mouth each evening. Manufacturer: Jarrow Industries, Inc.; Brand name: N-A-C Sustain
Drug: N-acetylcysteine
N-acetylcysteine is a safe, widely available supplement currently FDA-approved for treatment of acetaminophen antidote and as a mucolytic. It has effects on glutamate in the brain via the NMDA receptor as well as the glutathione antioxidant system (it is a precursor to glutathione).
Other Name: NAC, acetylcysteine, cysteine, Acetadote

Other: Treatment as Usual
Treatment for schizophrenia which may include medications, therapy, or other types of treatment as determined by the subject's VA or community psychiatrist or mental health treatment team

Placebo Comparator: Placebo
Patients in this group will receive placebo tablets indistinguishable from NAC tablets, with the same protocol as NAC: two placebo tablets by mouth each morning, and two placebo tablets by mouth each evening. Manufacturer: Jarrow Industries, Inc.; Brand name: N-A-C Sustain
Other: Treatment as Usual
Treatment for schizophrenia which may include medications, therapy, or other types of treatment as determined by the subject's VA or community psychiatrist or mental health treatment team




Primary Outcome Measures :
  1. Improvement of negative symptoms [ Time Frame: 0 weeks (baseline), 4 weeks and 8 weeks of treatment with NAC ]
    Negative symptoms will be assessed with the PANSS and the CAINS

  2. Glutamate levels in prefrontal cortex [ Time Frame: 0 weeks (baseline) and 8 weeks of treatment with NAC ]
    Patients will undergo a magnetic resonance spectroscopy scan to measure glutamate levels in prefrontal cortex

  3. Glutathione levels in prefrontal cortex [ Time Frame: 0 weeks (baseline) and 8 weeks of treatment with NAC ]
    Patients will undergo a magnetic resonance spectroscopy scan to measure glutathione levels in prefrontal cortex


Secondary Outcome Measures :
  1. Whole blood glutathione level [ Time Frame: 0 weeks (baseline) and 8 weeks of treatment with NAC ]

Other Outcome Measures:
  1. Cognitive Performance on the MCCB [ Time Frame: 0 weeks (baseline) and 8 weeks of treatment with NAC ]
    Patients will be evaluated for performance on the Matrics Consensus Cognitive Battery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet DSM-5 criteria for schizophrenia or schizoaffective disorder
  • Must be able to provide informed consent to participate in the research project

Exclusion Criteria:

  • Actively participating in other experimental drug trial(s) either currently or within the past month
  • Psychiatric hospitalization within the previous three months
  • Medical hospitalization or other acute medical problem within the previous three months
  • A greater than 50% change in dose of antipsychotic medication within the previous three months
  • They have met DSM-5 criteria for substance use disorder within the previous three months
  • History of neurological illness including stroke, epilepsy, or loss of consciousness for 60 minutes or more

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505477


Contacts
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Contact: Yvonne S Yang, MD, PhD 2038877674 ysyang@mednet.ucla.edu

Locations
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United States, California
UCLA Semel Institute for Neuroscience and Human Behavior Recruiting
Los Angeles, California, United States, 90024
Contact: Yvonne Yang, MD,PHD    310-478-3711 ext 42540    ysyang@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Yvonne Yang, MD, PhD Assistant Clinical Professor

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Responsible Party: Yvonne S. Yang, Health Sciences Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02505477     History of Changes
Other Study ID Numbers: FOS53929
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yvonne S. Yang, University of California, Los Angeles:
schiozphrenia
cognition
negative symptoms
glutamate
glutathione
N-acetylcysteine

Additional relevant MeSH terms:
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Schizophrenia
Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes