Effect of N-acetylcysteine on Brain Glutamate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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., 2012; 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.

Conditions

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Psychosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NAC or Placebo

Participants will receive 2400mg capsules of N-Acetylcysteine or placebo

N-Acetylcysteine

Intervention Type DIETARY_SUPPLEMENT

Participants will receive 2400mg of N-Acetylcysteine orally via 6 x 400mg capsules.

Placebo

Intervention Type OTHER

Participants will receive 2400mg of placebo orally via 6 x 400mg capsules.

Interventions

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N-Acetylcysteine

Participants will receive 2400mg of N-Acetylcysteine orally via 6 x 400mg capsules.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will receive 2400mg of placebo orally via 6 x 400mg capsules.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No