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The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm
We will enroll 8 subjects in an open label, three session pilot in patients will receive three sessions of tone matching SBR.
5 Subjects will receive D-serine (60mg/kg) taken 1x each week during the SBR sessions. Subjects will receive study drug 30 minutes prior to session.
3 subjects received no intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-serine | Experimental | D-serine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-serine | Drug | D-serine 60 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mismatch Negativity (MMN) | An MMN event is evoked by a discernible change in the pitch of a repetitive auditory stimulation. The stronger the response to a difference (i.e., the more negative the amplitude of the MMN), the better the outcome. MMN was obtained to pitch deviant stimuli pre-post auditory plasticity training, utilizing deviants to the same base frequencies as the auditory plasticity sessions, (i.e. 500, 1000, and 2000 Hz), with ~10 minutes of each base frequency. MMN will be conducted at baseline and after the final session. Reported outcome is change in MMN between baseline and final within session. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tone Matching Threshold | Change tone matching threshold (the percent difference in pitch of two consecutively played tones that can be distinguished), higher numbers represent better outcomes. D-serine outcomes are for 2 consecutive D-serine sessions | three weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua T Kantrowitz, MD | Nathan Kline Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nathan Kline Institute | Orangeburg | New York | 10962 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27913408 | Result | Kantrowitz JT, Epstein ML, Beggel O, Rohrig S, Lehrfeld JM, Revheim N, Lehrfeld NP, Reep J, Parker E, Silipo G, Ahissar M, Javitt DC. Neurophysiological mechanisms of cortical plasticity impairments in schizophrenia and modulation by the NMDA receptor agonist D-serine. Brain. 2016 Dec;139(Pt 12):3281-3295. doi: 10.1093/brain/aww262. |
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Please see NCT01474395 for a related parallel study involving 13 schizophrenia patients and 13 healthy controls. Participants in NCT01474395 were not enrolled in the current study, i.e., both studies included separate groups of participants
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| ID | Title | Description |
|---|---|---|
| FG000 | D-serine | D-serine D-serine: D-serine 60 mg/kg (3 sessions, open label) |
| FG001 | No Intervention | 3 sessions without D-serine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | D-serine | D-serine D-serine: D-serine 60 mg/kg |
| BG001 | No Intervention | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mismatch Negativity (MMN) | An MMN event is evoked by a discernible change in the pitch of a repetitive auditory stimulation. The stronger the response to a difference (i.e., the more negative the amplitude of the MMN), the better the outcome. MMN was obtained to pitch deviant stimuli pre-post auditory plasticity training, utilizing deviants to the same base frequencies as the auditory plasticity sessions, (i.e. 500, 1000, and 2000 Hz), with ~10 minutes of each base frequency. MMN will be conducted at baseline and after the final session. Reported outcome is change in MMN between baseline and final within session. | Posted | Mean | Standard Deviation | micro volts | 3 weeks |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-serine | D-serine D-serine: D-serine 60 mg/kg | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Kantrowitz | Nathan Kline Institute | 646-774-6738 | josh.kantrowitz@nki.rfmh.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Tone Matching Threshold | Change tone matching threshold (the percent difference in pitch of two consecutively played tones that can be distinguished), higher numbers represent better outcomes. D-serine outcomes are for 2 consecutive D-serine sessions | Posted | Mean | Standard Deviation | percentage of difference in pitch | three weeks |
|
|
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| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | no Intervention | no intervention | 0 | 3 | 0 | 3 | 0 | 3 |
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