Effect of N-acetylcysteine on Brain Glutamate (NAC)
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|ClinicalTrials.gov Identifier: NCT02483130|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment|
|Psychosis||Dietary Supplement: N-Acetylcysteine Other: Placebo|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|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 Start Date :||June 2015|
|Primary Completion Date :||February 28, 2017|
|Study Completion Date :||February 28, 2017|
NAC or Placebo
Participants will receive 2400mg capsules of N-Acetylcysteine or placebo
Dietary Supplement: N-Acetylcysteine
Participants will receive 2400mg of N-Acetylcysteine orally via 6 x 400mg capsules.Other: Placebo
Participants will receive 2400mg of placebo orally via 6 x 400mg capsules.
- Reduction in brain glutamate [ Time Frame: One hour post capsule ]The within-subjects difference in brain glutamate concentration following a single oral administration of placebo compared to 2400mg N-acetylcysteine
- Brain perfusion [ Time Frame: One hour post capsule ]The within-subjects change in regional brain perfusion, as assessed using pulsed continuous arterial spin labelling (pCASL) MRI, following a single oral administration of placebo compared to 2400mg N-acetylcysteine.
- Regional activity and connectivity [ Time Frame: One hour post capsule ]The within-subjects change in regional brain activity or connectivity, as assessed using resting state functional magnetic resonance imaging (rsfMRI), following a single oral administration of placebo compared to 2400mg N-acetylcysteine.
Biospecimen Retention: Samples With DNA
Samples are collected for two purposes.
- Participants are invited to donate samples to the BRC Bioresource. These samples may be used in the future for genetic, epigenetic, metabolomic or proteomic analysis.
- Participants will also be asked for a blood sample after completion of each MRI scan. These will be used to measure blood glutathione levels, which may be altered by N-acetylcysteine and therefore provide indication of pharmacological effect.
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): NCT02483130
|Institute of Psychiatry, Psychology and Neuroscience|
|Denmark Hill, London, United Kingdom, SE5 8AF|
|Principal Investigator:||James H McCabe||King's College London|