Effect of N-acetylcysteine on Brain Glutamate
Information source: King's College London
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psychosis
Intervention: N-Acetylcysteine (Dietary Supplement); Placebo (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: King's College London Official(s) and/or principal investigator(s): James H McCabe, Principal Investigator, Affiliation: King's College London
Overall contact: Alice Egerton, Phone: 00442078480721, Email: alice.egerton@kcl.ac.uk
Summary
A double-blind, placebo controlled, crossover study to determine whether a single dose of
N-acetylcysteine (a nutritional supplement) can reduce brain glutamate levels in patients
with a psychotic disorder. Secondary outcomes are to determine the pattern of alteration in
brain perfusion and activity following a single dose of N-acetylcysteine.
Clinical Details
Official title: A Randomised Controlled Double Blind Crossover Study of the Effect of a Single Dose of N-acetylcysteine Versus Placebo on Brain Glutamate in Patients With Psychotic Disorders
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Reduction in brain glutamate
Secondary outcome: Brain perfusionRegional activity and connectivity
Detailed description:
This is a physiological, proof-of-concept study designed to investigate whether a single
administration of N-acetylcysteine can reduce brain glutamate levels in people with
psychotic disorders.
Previous research suggests that poor response to antipsychotics may be linked to increased
levels of glutamate in the brain (Egerton et al., 2012Íž Demjaha, Egerton et al., 2013).
Reducing brain glutamate levels may therefore be therapeutic. This study tests whether it is
possible to reduce brain glutamate levels in psychotic disorders.
This is a small pilot study to determine whether a single administration of NAC can reduce
brain glutamate levels in psychosis. At the same time, we will also examine the effects of
NAC on brain resting perfusion and activity, to gain more information about how NAC may be
acting.
This study will recruit participants with a previous diagnosis of a psychotic disorder.
There will be three study visits, 1-2 weeks apart. The first visit will involve a physical
health check, blood sample and an interview to assess current symptoms and confirm medical
history. On the second and third visits participants will have an MRI scan, lasting one
hour, after taking capsules containing either 2400mg NAC or placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Over 18 years of age
- Diagnosis of a psychotic disorder
- Have mental capacity to consent
Exclusion Criteria:
- Diagnosed drug or alcohol dependency, with the exception of nicotine
- Pregnancy, as determined through a urine pregnancy test
- Presence of any physical health abnormality which may impact on safety to participate
in the research, as determined by a study clinician on the basis of the physical
health check and the available medical information.
- Presence of electronic or metallic implants contraindicated to MRI scanning at 3
Tesla, or presence of any other contraindication to MRI
- History of asthma
- History of epilepsy or any other seizure
- Under 18 years of age
- Lacking mental capacity to consent
- Current or previous use of NAC
- Currently prescribed clozapine
Locations and Contacts
Alice Egerton, Phone: 00442078480721, Email: alice.egerton@kcl.ac.uk Additional Information
Related publications: Egerton A, Brugger S, Raffin M, Barker GJ, Lythgoe DJ, McGuire PK, Stone JM. Anterior cingulate glutamate levels related to clinical status following treatment in first-episode schizophrenia. Neuropsychopharmacology. 2012 Oct;37(11):2515-21. doi: 10.1038/npp.2012.113. Epub 2012 Jul 4. Demjaha A, Egerton A, Murray RM, Kapur S, Howes OD, Stone JM, McGuire PK. Antipsychotic treatment resistance in schizophrenia associated with elevated glutamate levels but normal dopamine function. Biol Psychiatry. 2014 Mar 1;75(5):e11-3. doi: 10.1016/j.biopsych.2013.06.011. Epub 2013 Jul 25. Berk M, Copolov D, Dean O, Lu K, Jeavons S, Schapkaitz I, Anderson-Hunt M, Judd F, Katz F, Katz P, Ording-Jespersen S, Little J, Conus P, Cuenod M, Do KQ, Bush AI. N-acetyl cysteine as a glutathione precursor for schizophrenia--a double-blind, randomized, placebo-controlled trial. Biol Psychiatry. 2008 Sep 1;64(5):361-8. doi: 10.1016/j.biopsych.2008.03.004. Epub 2008 Apr 23.
Starting date: June 2015
Last updated: June 25, 2015
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