SchizophreniaPhase 1/2NCT03711500
D-serine Augmentation of Neuroplasticity
A Phase 1/2 study testing D-serine in people with Schizophrenia and Schizo Affective Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
Schizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder
- What is being tested?
- D-serine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2019to 30 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- Willing to provide informed consent
- Auditory Cognitive impairment demonstrated by:
- a .MCCB composite domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45) b. And at least one of the following:
- MCCB verbal memory domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45)
Show all 17Show fewer
- Tone matching score of less than or equal to 77.7%
- Clinically stable for 2 months (CGI less than or equal to 4)
- Moderate or lower cognitive disorganization (PANSS P2 less than or equal to 4)
- Medically stable for study participation
- Willing to use qualified methods of contraception for the study duration and up to 2 months after its end
- Fluent English speaker
- Normal hearing
- Visual acuity corrected to 20/30
- An estimated Glomerular Filtration Rate (GFR) greater than or equal to 60
- Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
- Judged clinically not to be at significant suicide or violence risk
Who cannot join
- ECG abnormality that is clinically significant in the context of study participation in the opinion of the study cardiologist
- Current clozapine use
- Presence of positive history of unstable significant medical or neurological illness
- Positive toxicology screen for any substances of abuse
- Substance use disorder (excluding nicotine) within last 60 days
- Pregnant women or women of child-bearing potential, who are either not surgically-sterile or for outpatients, using appropriate methods of birth control. Women of childbearing potential must have a negative serum -hCG pregnancy test at every visit.
- Participation in study of investigational medication/device within 4 weeks
- Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator Section
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute
New York, New York, 10032
Nathan Kline Institute
Orangeburg, New York, 10962
About this study
Official title: D-serine Augmentation of Neuroplasticity Based Auditory Learning in Schizophrenia
Schizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. In addition, schizophrenia patients show reduced "plasticity", defined as reduced learning.
D-serine is a naturally occurring activator of the N-methyl-d-aspartate-type glutamate receptors (NMDAR) in the brain, and this project will assess the optimal dose of D-serine treatment over three sessions of a program designed to measure auditory plasticity.
Read the detailed description
Schizophrenia (Sz) is a major public health problem associated with core cognitive deficits that are amongst the strongest predictors of impaired functional outcome. In addition, Sz patients show reduced cortical neuroplasticity, defined as reduced learning during training on exercises that place implicit, increasing demands on early auditory information processing. As improved auditory processing can facilitate gains in those cognitive processes that are more proximal to daily functioning (e.g., verbal memory, executive functioning), enhancing neuroplasticity for better auditory processing represents an unmet clinical need and a rate-limiting first step prior to remediating cognition and overall function.
As supported by recently published data and review, the study proposes that localized N-methyl-D-aspartate-type glutamate receptor (NMDAR) dysfunction leads to impaired auditory neuroplasticity, which in turn leads to impaired cognition. Over recent years, NMDAR glycine site agonists have increasingly been shown to facilitate neuroplasticity in both Sz and healthy volunteers.
D-serine is a NMDAR modulator that when combined with neuroplasticity-based auditory remediation, leads to highly significant, acute improvement in both auditory plasticity and the early auditory processing measures mismatch negativity (MMN) and theta intertrial coherence (theta). Both MMN and theta-ITC are sensitive measures of functional target engagement of both NMDAR agonism and auditory remediation. In a preliminary study, plasticity correlated with reading and working memory, suggesting plasticity improvements are predictive of functionally relevant outcomes. While D-serine appears to be efficacious for neuroplasticity enhancement and target engagement in a dose dependent manner, the optimal dose remains an open question, as does the ability of combined D-serine + neuroplasticity-based auditory remediation to produce sustained, functional improvement. This study utilizes the Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33): RFA-MH-17-702.
The ultimate goal of this study is to enhance efficacy and efficiency of auditory cognitive remediation by augmenting with D-serine. This study will confirm target engagement, pharmacodynamics, functional relationships and the optimal dose (80 vs.100 vs. 120 mg/kg, IND: 122821) of D-serine treatment combined with 3 sessions of our auditory remediation program. As previously, D-serine will be given 30 minutes before sessions, allowing for auditory remediation during peak serum levels and a pharmacodynamic assessment. Successful completion is defined by ≥moderate effect size change in auditory plasticity, MMN and theta, plus a moderate effect size correlation with functionally relevant cognitive measures ("auditory cognition") without safety issues. Successful completion of this study will pave the way for a larger, definitive study pairing D-serine with auditory remediation or testing alternative dose intervals (1x vs. 2x week). In addition to testing a potentially viable treatment, this project will stimulate industry to utilize this methodology to assess the efficacy of novel NMDAR modulators, using D-serine as a "gold-standard."
- Conditions
- Schizophrenia, Schizo Affective Disorder
- Being tested
- D-serine, Placebo
- Keywords
- plasticity
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-serineDrug
Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
PlaceboDrug
Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
| Study group | Role | What they receive |
|---|---|---|
| D-serine 80 mg/kg | Experimental | Not described Receives: Drug: D-serine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| D-serine 100 mg/kg | Experimental | Not described Receives: Drug: D-serine |
| D-serine 120 mg/g | Experimental | Not described Receives: Drug: D-serine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasticity Improvement (Change in Tone Matching Threshold)
Participants underwent three treatment sessions, 1x week.
This is the outcome of the auditory remediation. In Auditory Remediation, participants are presented with paired tones (e.g. Stimulus 1 ("reference") and Stimulus 2 ("test"): S1 and S2) and indicate which tone is higher in pitch (frequency). In the first pair, the ratio is 50% (e.g. 1000±500 Hz). A two-down/one-up staircase procedure is used to adjust the ratio to maintain a steady (~70% correct) level of performance across the trial.
The tone matching threshold was calculated at the initial plateau (trials 20-30 during treatment session 1) and at the end of treatment session three. Plasticity Improvement was operationalized as change in threshold from initial plateau to the end of treatment visit 3. Larger (more positive) values represent greater improvement in threshold. Zero would represent no improvement. Values were log transformed.
Measured: At the end of Treatment session 3 (3rd of three sessions)
Mismatch Negativity (MMN)
MMN is measured by electroencephalogram (EEG). MMN will be obtained independently to pitch stimuli utilizing the same base frequency as the plasticity task described in outcome 1. MMN was assessed immediately before the first dose and immediately after treatment sessions 2 and 3. MMN will be generated using previously published methods. Peak amplitude at frontocentral electrodes within predefined latency range will be primary outcome measure. This value represents the mean MMN to pitch post baseline (after sessions 2 and 3). More negative represents larger MMN.
Measured: Post baseline
Theta Intertrial Coherence (Theta)
Theta is measured by EEG, during the motor-preparation interval (200-500 ms post-the second tone: S2) during the auditory remediation task. Theta inter-trial coherence (ITC) reflects the consistency of spectral response across repeated trials ranging from 0 (no consistency) to 1 (perfect consistency). Higher values represent better consistency.
Measured: Week 1
Number of Patients With Granular Casts
This is a safety measure conducted by urinalysis after each D-serine dose. The outcome is the count of participants with granular casts.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start13 Mar 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Responsible party
- Principal investigator, Joshua Kantrowitz, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711500
- Sponsor's protocol ID
- 7725
- Status last verified
- May 2022
- First submitted
- 11 Oct 2018
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Govani V, Shastry AM, Iosifescu DV, Govil P, Mayer MR, Sobeih T, Choo TH, Wall MM, Sehatpour P, Kantrowitz JT. Augmentation of learning in schizophrenia by d-serine and auditory remediation is related to auditory and frontally-generated biomarkers: A randomized, double-blind, placebo-controlled study. Schizophr Res. 2023 Oct;260:205-208. doi: 10.1016/j.schres.2023.08.027. Epub 2023 Sep 11. No abstract available.
PubMed 37690312Govani V, Shastry A, Iosifescu D, Govil P, Mayer M, Sobeih T, Choo T, Wall M, Sehatpour P, Kantrowitz J. Augmentation of learning in schizophrenia by D-serine is related to auditory and frontally-generated biomarkers: A randomized, double-blind, placebo-controlled study. Res Sq [Preprint]. 2023 May 19:rs.3.rs-2943290. doi: 10.21203/rs.3.rs-2943290/v1.
PubMed 37293030Sehatpour P, Iosifescu DV, De Baun HM, Shope C, Mayer MR, Gangwisch J, Dias E, Sobeih T, Choo TH, Wall MM, Medalia A, Saperstein AM, Kegeles LS, Girgis RR, Carlson M, Kantrowitz JT. Dose-Dependent Augmentation of Neuroplasticity-Based Auditory Learning in Schizophrenia: A Double-Blind, Placebo-Controlled, Randomized, Target Engagement Clinical Trial of the NMDA Glutamate Receptor Agonist d-serine. Biol Psychiatry. 2023 Jul 15;94(2):164-173. doi: 10.1016/j.biopsych.2023.01.015. Epub 2023 Jan 28.
PubMed 36958998
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-serine Augmentation of Neuroplasticity Based Auditory Learning in Schizophrenia
- ClinicalTrials.gov ID
- NCT03711500
- Acronym / sponsor ID
- 7725
- Conditions
- Schizophrenia, Schizo Affective Disorder
- Keywords
- plasticity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 14 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. In addition, schizophrenia patients show reduced "plasticity", defined as reduced learning.
D-serine is a naturally occurring activator of the N-methyl-d-aspartate-type glutamate receptors (NMDAR) in the brain, and this project will assess the optimal dose of D-serine treatment over three sessions of a program designed to measure auditory plasticity.
Detailed description
Schizophrenia (Sz) is a major public health problem associated with core cognitive deficits that are amongst the strongest predictors of impaired functional outcome. In addition, Sz patients show reduced cortical neuroplasticity, defined as reduced learning during training on exercises that place implicit, increasing demands on early auditory information processing. As improved auditory processing can facilitate gains in those cognitive processes that are more proximal to daily functioning (e.g., verbal memory, executive functioning), enhancing neuroplasticity for better auditory processing represents an unmet clinical need and a rate-limiting first step prior to remediating cognition and overall function.
As supported by recently published data and review, the study proposes that localized N-methyl-D-aspartate-type glutamate receptor (NMDAR) dysfunction leads to impaired auditory neuroplasticity, which in turn leads to impaired cognition. Over recent years, NMDAR glycine site agonists have increasingly been shown to facilitate neuroplasticity in both Sz and healthy volunteers.
D-serine is a NMDAR modulator that when combined with neuroplasticity-based auditory remediation, leads to highly significant, acute improvement in both auditory plasticity and the early auditory processing measures mismatch negativity (MMN) and theta intertrial coherence (theta). Both MMN and theta-ITC are sensitive measures of functional target engagement of both NMDAR agonism and auditory remediation. In a preliminary study, plasticity correlated with reading and working memory, suggesting plasticity improvements are predictive of functionally relevant outcomes. While D-serine appears to be efficacious for neuroplasticity enhancement and target engagement in a dose dependent manner, the optimal dose remains an open question, as does the ability of combined D-serine + neuroplasticity-based auditory remediation to produce sustained, functional improvement. This study utilizes the Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33): RFA-MH-17-702.
The ultimate goal of this study is to enhance efficacy and efficiency of auditory cognitive remediation by augmenting with D-serine. This study will confirm target engagement, pharmacodynamics, functional relationships and the optimal dose (80 vs.100 vs. 120 mg/kg, IND: 122821) of D-serine treatment combined with 3 sessions of our auditory remediation program. As previously, D-serine will be given 30 minutes before sessions, allowing for auditory remediation during peak serum levels and a pharmacodynamic assessment. Successful completion is defined by ≥moderate effect size change in auditory plasticity, MMN and theta, plus a moderate effect size correlation with functionally relevant cognitive measures ("auditory cognition") without safety issues. Successful completion of this study will pave the way for a larger, definitive study pairing D-serine with auditory remediation or testing alternative dose intervals (1x vs. 2x week). In addition to testing a potentially viable treatment, this project will stimulate industry to utilize this methodology to assess the efficacy of novel NMDAR modulators, using D-serine as a "gold-standard."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D-serine 80 mg/kg | Experimental | Drug: D-serine |
| Placebo | Placebo comparator | Drug: Placebo |
| D-serine 100 mg/kg | Experimental | Drug: D-serine |
| D-serine 120 mg/g | Experimental | Drug: D-serine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age between 18 and 50
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- Willing to provide informed consent
- Auditory Cognitive impairment demonstrated by:
- a .MCCB composite domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45) b. And at least one of the following:
Key exclusion criteria (8 listed)
- ECG abnormality that is clinically significant in the context of study participation in the opinion of the study cardiologist
- Current clozapine use
- Presence of positive history of unstable significant medical or neurological illness
- Positive toxicology screen for any substances of abuse
- Substance use disorder (excluding nicotine) within last 60 days
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 |
|---|---|---|
| D-serineSubjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort | Drug | D-serine 100 mg/kg, D-serine 120 mg/g, D-serine 80 mg/kg |
| PlaceboSubjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort | Drug | Placebo |
Primary outcome
Plasticity Improvement (Change in Tone Matching Threshold)
Time frame: At the end of Treatment session 3 (3rd of three sessions)
Participants underwent three treatment sessions, 1x week. This is the outcome of the auditory remediation. In Auditory Remediation, participants are presented with paired tones (e.g. Stimulus 1 ("reference") and Stimulus 2 ("test"): S1 and S2) and indicate which tone is higher in pitch (frequency). In the first pair, the ratio is 50% (e.g. 1000±500 Hz). A two-down/one-up staircase procedure is used to adjust the ratio to maintain a steady (~70% correct) level of performance across the trial. The tone matching threshold was calculated at the initial plateau (trials 20-30 during treatment session 1) and at the end of treatment session three. Plasticity Improvement was operationalized as change in threshold from initial plateau to the end of treatment visit 3. Larger (more positive) values represent greater improvement in threshold. Zero would represent no improvement. Values were log transformed.
Mismatch Negativity (MMN)
Time frame: Post baseline
MMN is measured by electroencephalogram (EEG). MMN will be obtained independently to pitch stimuli utilizing the same base frequency as the plasticity task described in outcome 1. MMN was assessed immediately before the first dose and immediately after treatment sessions 2 and 3. MMN will be generated using previously published methods. Peak amplitude at frontocentral electrodes within predefined latency range will be primary outcome measure. This value represents the mean MMN to pitch post baseline (after sessions 2 and 3). More negative represents larger MMN.
Theta Intertrial Coherence (Theta)
Time frame: Week 1
Theta is measured by EEG, during the motor-preparation interval (200-500 ms post-the second tone: S2) during the auditory remediation task. Theta inter-trial coherence (ITC) reflects the consistency of spectral response across repeated trials ranging from 0 (no consistency) to 1 (perfect consistency). Higher values represent better consistency.
Number of Patients With Granular Casts
Time frame: Three weeks
This is a safety measure conducted by urinalysis after each D-serine dose. The outcome is the count of participants with granular casts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37690312Govani V, Shastry AM, Iosifescu DV, Govil P, Mayer MR, Sobeih T, Choo TH, Wall MM, Sehatpour P, Kantrowitz JT. Augmentation of learning in schizophrenia by d-serine and auditory remediation is related to auditory and frontally-generated biomarkers: A randomized, double-blind, placebo-controlled study. Schizophr Res. 2023 Oct;260:205-208. doi: 10.1016/j.schres.2023.08.027. Epub 2023 Sep 11. No abstract available.
- Derived from this study: PubMed 37293030Govani V, Shastry A, Iosifescu D, Govil P, Mayer M, Sobeih T, Choo T, Wall M, Sehatpour P, Kantrowitz J. Augmentation of learning in schizophrenia by D-serine is related to auditory and frontally-generated biomarkers: A randomized, double-blind, placebo-controlled study. Res Sq [Preprint]. 2023 May 19:rs.3.rs-2943290. doi: 10.21203/rs.3.rs-2943290/v1.
- Derived from this study: PubMed 36958998Sehatpour P, Iosifescu DV, De Baun HM, Shope C, Mayer MR, Gangwisch J, Dias E, Sobeih T, Choo TH, Wall MM, Medalia A, Saperstein AM, Kegeles LS, Girgis RR, Carlson M, Kantrowitz JT. Dose-Dependent Augmentation of Neuroplasticity-Based Auditory Learning in Schizophrenia: A Double-Blind, Placebo-Controlled, Randomized, Target Engagement Clinical Trial of the NMDA Glutamate Receptor Agonist d-serine. Biol Psychiatry. 2023 Jul 15;94(2):164-173. doi: 10.1016/j.biopsych.2023.01.015. Epub 2023 Jan 28.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D-serine in people with Schizophrenia and Schizo Affective Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
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 17 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: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasticity Improvement (Change in Tone Matching Threshold) (time frame: At the end of Treatment session 3 (3rd of three sessions)). The study lists 4 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 NCT03711500, which also lists 3 linked publications.
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 14 Jun 2022.