Anti-N-Methyl-D-Aspartate Receptor EncephalitisDANCE-AENCT05280600
Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis
An observational study of Anti-N-Methyl-D-Aspartate Receptor Encephalitis and Autoimmune Encephalitis, run by King's College London at 1 site in United Kingdom.
Trial summary
Autoimmune encephalitis is brain inflammation caused by the immune system mistakenly reacting against proteins in the brain. The commonest form is called NMDAR-antibody encephalitis (N-methyl-D-aspartate receptor antibody encephalitis), a rare condition which mainly affects children and young people and causes… Read more about this study
- Who is it for?
- Ages 8 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Autoimmune Encephalitis
- What is being tested?
- Not applicable - non-interventional study
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2022to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All participants will be recruited in the United Kingdom. NMDAR-antibody encephalitis and antibody-negative autoimmune encephalitis groups: Identified by neurologists/paediatric neurologists in secondary/tertiary healthcare settings, or by self-referral via the Encephalitis Society. Healthy control group: Identified from King's College London volunteer databases, friends and siblings of autoimmune encephalitis cases, or recruited from local schools and colleges.
Who may be able to join
- NMDAR-antibody encephalitis group:
- Age 8-24 years at study enrollment.
- Disease onset in the last 12 months before study enrollment.
- Meets consensus diagnostic criteria (Graus et al., 2016) for either probable anti-NMDAR encephalitis OR definite anti-NMDAR encephalitis.
- Antibody-negative autoimmune encephalitis group:
- Age 8-24 years at study enrollment.
Show all 10Show fewer
- Disease onset in the last 12 months before study enrollment.
- Meets consensus diagnostic criteria (Graus et al., 2016) for either autoantibody-negative but probable autoimmune encephalitis OR definite autoimmune limbic encephalitis.
- Healthy control group:
- 1. Age 8-24 years at study enrollment.
Who cannot join
- All participants:
- 1. Any clear contra-indication for an MRI scan. In particular this would be due to the presence of any implanted devices or metal from previous surgery or accident.
- Healthy control group:
- 1. A known neurological or neurodevelopmental disorder.
- NMDAR-antibody encephalitis and antibody-negative autoimmune encephalitis groups:
- Alternative more likely cause of neurological symptoms than autoimmune encephalitis, i.e. reasonable exclusion of other diagnoses as per consensus criteria (Graus et al., 2016).
- Severe movement disorder/uncontrolled epilepsy/dysautonomia.
- Previous infective encephalitis with major destructive brain lesions.
Trial locations and contacts
1 site in 1 country.
David W Carmichael, PhD MSci contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 7EH
Michael R Eyre, MBBS MRes, michael.eyre@kcl.ac.uk
Ming J Lim, MBBS PhD, ming.lim@gstt.nhs.uk
About this study
Autoimmune encephalitis is brain inflammation caused by the immune system mistakenly reacting against proteins in the brain. The commonest form is called NMDAR-antibody encephalitis (N-methyl-D-aspartate receptor antibody encephalitis), a rare condition which mainly affects children and young people and causes difficulties in memory, thinking and mental health which can have significant long-term impacts on education, employment and quality of life.
In this project we will use advanced magnetic resonance imaging (MRI) to measure changes in the structure, function and chemistry of the brains of children and young people who are in early recovery from NMDAR-antibody encephalitis and other forms of immune-mediated encephalitis. We will investigate if MRI measurements in patients differ from those in healthy people, and if they can help predict patient outcome one year later, assessed by tests of memory, thinking, mental health and functioning in daily life.
Read the detailed description
This study aims to develop non-invasive, in vivo measures of neurobiological dysfunction derived from the overarching hypothesis that dysfunction of inhibitory interneurons alters the cerebral concentrations of gamma-aminobutyric acid (GABA) and glutamate (Glu) and underlies T2 changes and deficient connectivity in functional networks in early recovery from NMDAR-antibody encephalitis. Our ambition is to identify the best potential prognostic biomarkers from these neurometabolite measurements and structural and functional MRI.
Our primary objective is to test the following specific hypotheses in children and young people with NMDAR-antibody encephalitis:
- Hypothesis 1: GABA is decreased, and Glu increased, on MR spectroscopy of the medial temporal lobe and medial prefrontal cortex in NMDAR-antibody encephalitis.
- Hypothesis 2: Local GABA and Glu are correlated with (i) resting-state functional MRI (fMRI) based functional connectivity and (ii) parameter map-based microstructural changes. Specifically, we hypothesise that (i) GABA is positively correlated and Glu inversely correlated with functional connectivity, assessed by whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity; and (ii) Glu is positively correlated and GABA inversely correlated with median T2 values within the hippocampus.
- Hypothesis 3: Local neurometabolites, network measures and microstructural changes predict cognitive, psychiatric and functional outcome at one year. Specifically, we hypothesise that medial temporal Glu, GABA and hippocampal T2 predict memory performance, and prefrontal Glu and GABA predict attention, executive function and fluid intelligence.
- Being tested
- Not applicable - non-interventional study
- Keywords
- Magnetic resonance imaging (MRI), Magnetic resonance spectroscopy (MRS), Resting-state functional MRI, Cognition, Ultra-high field MRI
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - non-interventional studyOther
Not applicable - non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| NMDAR-antibody encephalitis | Children and young people (ages 8-24 years) with a diagnosis of NMDAR-antibody encephalitis. Receives: Other: Not applicable - non-interventional study | |
| Antibody-negative autoimmune encephalitis | Children and young people (ages 8-24 years) with a diagnosis of autoantibody-negative but probable autoimmune encephalitis or definite autoimmune limbic encephalitis. Receives: Other: Not applicable - non-interventional study | |
| Healthy control | Healthy children and young people (ages 8-24 years). Receives: Other: Not applicable - non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral concentrations of GABA and glutamate at the prefrontal cortex and left medial temporal lobe
Measured with MR spectroscopy - stimulated echo acquisition mode (STEAM) sequence
Measured: Baseline
Structural MRI
Quantitative MRI parameter maps including measurement of median T2 values in the hippocampus
Measured: Baseline
Resting-state fMRI
Whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity
Measured: Baseline
Secondary outcomes (16)
Wechsler Abbreviated Scale of Intelligence 2nd Edition (WASI-II)
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Rey Auditory Verbal Learning Test (RAVLT)
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Doors & People Test
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Paired Associates Learning
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Rapid Visual Information Processing
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Spatial Span
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Intra-Extra Dimensional Set Shift
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Stockings of Cambridge
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Stop Signal Task
Cognitive test (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Prodromal Questionnaire Brief Version (PQ-B)
Questionnaire-based psychiatric symptom score (lower score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Patient Health Questionnaire (PHQ-9)
Questionnaire-based psychiatric symptom score (lower score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Questionnaire-based psychiatric symptom score (lower score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales
Questionnaire-based functional outcome score (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
PedsQL Multidimensional Fatigue Scale
Questionnaire-based functional outcome score (higher score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Behaviour Rating Inventory of Executive Function (BRIEF)
Questionnaire-based functional outcome score (lower score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Conners 3 Short Form / Conners' Adult ADHD Rating Scale
Questionnaire-based functional outcome score (lower score indicating better outcome)
Measured: Baseline (all groups), 1 year (patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start19 May 2022
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-N-Methyl-D-Aspartate Receptor EncephalitisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Action Medical Research
- Responsible party
- Sponsor
- Investigators
- David W Carmichael, PhD MSci, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280600
- Sponsor's protocol ID
- KCL21-018
- Other IDs
- GN2835, IRAS 297793
- Acronym
- DANCE-AE
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consent will be requested from participants to share imaging data and summary clinical and demographic data. Where participants consent, imaging data will be de-identified, removing facial features from the magnetic resonance images and all identifying information will be removed from the image header (the part of the file that describes how the image data was acquired). The resulting data will be shared together with anonymised clinical data at the request of other researchers.
Publications
Graus F, Titulaer MJ, Balu R, Benseler S, Bien CG, Cellucci T, Cortese I, Dale RC, Gelfand JM, Geschwind M, Glaser CA, Honnorat J, Hoftberger R, Iizuka T, Irani SR, Lancaster E, Leypoldt F, Pruss H, Rae-Grant A, Reindl M, Rosenfeld MR, Rostasy K, Saiz A, Venkatesan A, Vincent A, Wandinger KP, Waters P, Dalmau J. A clinical approach to diagnosis of autoimmune encephalitis. Lancet Neurol. 2016 Apr;15(4):391-404. doi: 10.1016/S1474-4422(15)00401-9. Epub 2016 Feb 20.
PubMed 26906964
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT05280600
- Acronym / sponsor ID
- DANCE-AE / KCL21-018
- Keywords
- Magnetic resonance imaging (MRI), Magnetic resonance spectroscopy (MRS), Resting-state functional MRI, Cognition, Ultra-high field MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Action Medical Research
- Study start
- 19 May 2022 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autoimmune encephalitis is brain inflammation caused by the immune system mistakenly reacting against proteins in the brain. The commonest form is called NMDAR-antibody encephalitis (N-methyl-D-aspartate receptor antibody encephalitis), a rare condition which mainly affects children and young people and causes difficulties in memory, thinking and mental health which can have significant long-term impacts on education, employment and quality of life.
In this project we will use advanced magnetic resonance imaging (MRI) to measure changes in the structure, function and chemistry of the brains of children and young people who are in early recovery from NMDAR-antibody encephalitis and other forms of immune-mediated encephalitis. We will investigate if MRI measurements in patients differ from those in healthy people, and if they can help predict patient outcome one year later, assessed by tests of memory, thinking, mental health and functioning in daily life.
Detailed description
This study aims to develop non-invasive, in vivo measures of neurobiological dysfunction derived from the overarching hypothesis that dysfunction of inhibitory interneurons alters the cerebral concentrations of gamma-aminobutyric acid (GABA) and glutamate (Glu) and underlies T2 changes and deficient connectivity in functional networks in early recovery from NMDAR-antibody encephalitis. Our ambition is to identify the best potential prognostic biomarkers from these neurometabolite measurements and structural and functional MRI.
Our primary objective is to test the following specific hypotheses in children and young people with NMDAR-antibody encephalitis:
- Hypothesis 1: GABA is decreased, and Glu increased, on MR spectroscopy of the medial temporal lobe and medial prefrontal cortex in NMDAR-antibody encephalitis.
- Hypothesis 2: Local GABA and Glu are correlated with (i) resting-state functional MRI (fMRI) based functional connectivity and (ii) parameter map-based microstructural changes. Specifically, we hypothesise that (i) GABA is positively correlated and Glu inversely correlated with functional connectivity, assessed by whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity; and (ii) Glu is positively correlated and GABA inversely correlated with median T2 values within the hippocampus.
- Hypothesis 3: Local neurometabolites, network measures and microstructural changes predict cognitive, psychiatric and functional outcome at one year. Specifically, we hypothesise that medial temporal Glu, GABA and hippocampal T2 predict memory performance, and prefrontal Glu and GABA predict attention, executive function and fluid intelligence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMDAR-antibody encephalitis | – | Other: Not applicable - non-interventional studyChildren and young people (ages 8-24 years) with a diagnosis of NMDAR-antibody encephalitis. |
| Antibody-negative autoimmune encephalitis | – | Other: Not applicable - non-interventional studyChildren and young people (ages 8-24 years) with a diagnosis of autoantibody-negative but probable autoimmune encephalitis or definite autoimmune limbic encephalitis. |
| Healthy control | – | Other: Not applicable - non-interventional studyHealthy children and young people (ages 8-24 years). |
Who may qualify
- Ages
- 8 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All participants will be recruited in the United Kingdom. NMDAR-antibody encephalitis and antibody-negative autoimmune encephalitis groups: Identified by neurologists/paediatric neurologists in secondary/tertiary healthcare settings, or by self-referral via the Encephalitis Society. Healthy control group: Identified from King's College London volunteer databases, friends and siblings of autoimmune encephalitis cases, or recruited from local schools and colleges.
Key inclusion criteria (10 listed)
- Age 8-24 years at study enrollment.
- Disease onset in the last 12 months before study enrollment.
- Meets consensus diagnostic criteria (Graus et al., 2016) for either probable anti-NMDAR encephalitis OR definite anti-NMDAR encephalitis.
- Age 8-24 years at study enrollment.
- Disease onset in the last 12 months before study enrollment.
Key exclusion criteria (8 listed)
- 1. Any clear contra-indication for an MRI scan. In particular this would be due to the presence of any implanted devices or metal from previous surgery or accident.
- 1. A known neurological or neurodevelopmental disorder.
- Alternative more likely cause of neurological symptoms than autoimmune encephalitis, i.e. reasonable exclusion of other diagnoses as per consensus criteria (Graus et al., 2016).
- Severe movement disorder/uncontrolled epilepsy/dysautonomia.
- Previous infective encephalitis with major destructive brain lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable - non-interventional studyNot applicable - non-interventional study | Other | Antibody-negative autoimmune encephalitis, Healthy control, NMDAR-antibody encephalitis |
Primary outcome
Cerebral concentrations of GABA and glutamate at the prefrontal cortex and left medial temporal lobe
Time frame: Baseline
Measured with MR spectroscopy - stimulated echo acquisition mode (STEAM) sequence
Structural MRI
Time frame: Baseline
Quantitative MRI parameter maps including measurement of median T2 values in the hippocampus
Resting-state fMRI
Time frame: Baseline
Whole-brain mapping of the default mode network and seed-based analysis of hippocampal-frontal connectivity
16 secondary outcomes
Wechsler Abbreviated Scale of Intelligence 2nd Edition (WASI-II)
Time frame: Baseline (all groups), 1 year (patients)
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline (all groups), 1 year (patients)
Doors & People Test
Time frame: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Paired Associates Learning
Time frame: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Rapid Visual Information Processing
Time frame: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Spatial Span
Time frame: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Intra-Extra Dimensional Set Shift
Time frame: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Stockings of Cambridge
Time frame: Baseline (all groups), 1 year (patients)
CANTAB (Cambridge Cognition, UK): Stop Signal Task
Time frame: Baseline (all groups), 1 year (patients)
Prodromal Questionnaire Brief Version (PQ-B)
Time frame: Baseline (all groups), 1 year (patients)
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (all groups), 1 year (patients)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Baseline (all groups), 1 year (patients)
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales
Time frame: Baseline (all groups), 1 year (patients)
PedsQL Multidimensional Fatigue Scale
Time frame: Baseline (all groups), 1 year (patients)
Behaviour Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline (all groups), 1 year (patients)
Conners 3 Short Form / Conners' Adult ADHD Rating Scale
Time frame: Baseline (all groups), 1 year (patients)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 26906964Graus F, Titulaer MJ, Balu R, Benseler S, Bien CG, Cellucci T, Cortese I, Dale RC, Gelfand JM, Geschwind M, Glaser CA, Honnorat J, Hoftberger R, Iizuka T, Irani SR, Lancaster E, Leypoldt F, Pruss H, Rae-Grant A, Reindl M, Rosenfeld MR, Rostasy K, Saiz A, Venkatesan A, Vincent A, Wandinger KP, Waters P, Dalmau J. A clinical approach to diagnosis of autoimmune encephalitis. Lancet Neurol. 2016 Apr;15(4):391-404. doi: 10.1016/S1474-4422(15)00401-9. Epub 2016 Feb 20.
- Individual participant dataSharing planned: Yes. Consent will be requested from participants to share imaging data and summary clinical and demographic data. Where participants consent, imaging data will be de-identified, removing facial features from the magnetic resonance images and all identifying information will be removed from the image header (the part of the file that describes how the image data was acquired). The resulting data will be shared together with anonymised clinical data at the request of other researchers.
Related trials for Anti-N-Methyl-D-Aspartate Receptor Encephalitis
RecruitingPhase 2
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE), Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis
NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis
Not yet recruitingObservational study
Clinical Evaluation of a Novel DAB Chromogenic Tissue-Based Assay for Detecting Anti-GABABR Antibodies
Autoimmune Encephalitis, Anti-NMDAR Encephalitis
RecruitingPhase 2
Efgartigimod in Anti-NMDA Receptor Encephalitis.
Encephalitis Autoimmune
RecruitingPhase 3
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Carmichael, PhD MSci contact
David W Carmichael, PhD MSci principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-N-Methyl-D-Aspartate Receptor Encephalitis and Autoimmune Encephalitis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael R Eyre, MBBS MRes (+44 207 1887188 ext. 56322, michael.eyre@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral concentrations of GABA and glutamate at the prefrontal cortex and left medial temporal lobe (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.