Trial · NCT03711500
D-serine Augmentation of Neuroplasticity
NCT03711500, Phase 1, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2022-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. D-serine Augmentation of Neuroplasticity. Trials, record NCT03711500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03711500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- D-serine Augmentation of Neuroplasticity
- NCT number
- NCT03711500
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Schizophrenia, Schizo Affective Disorder
- Interventions
- D-serine, Placebo
- First posted
- 2018-10-18
- Last updated
- 2022-06-14
- Results first posted
- 2022-06-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasticity Improvement (Change in Tone Matching Threshold) | 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. |
| Primary | Mismatch Negativity (MMN) | 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. |
| Primary | Theta Intertrial Coherence (Theta) | 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. |
| Primary | Number of Patients With Granular Casts | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasticity Improvement (Change in Tone Matching Threshold) | At the end of Treatment session 3 (3rd of three sessions) | randomized | log ratio | MEAN |
| PRIMARY | Mismatch Negativity (MMN) | Post baseline | randomized | amplitude, micro volts | MEAN |
| PRIMARY | Theta Intertrial Coherence (Theta) | Week 1 | randomized | correlation coefficient (r) | MEAN |
| PRIMARY | Number of Patients With Granular Casts | Three weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasticity Improvement (Change in Tone Matching Threshold) | D-serine 80 mg/kg | 13.9 | Standard Deviation 17.5 | log ratio | |
| Plasticity Improvement (Change in Tone Matching Threshold) | Placebo | 5.3 | Standard Deviation 10.8 | log ratio | |
| Plasticity Improvement (Change in Tone Matching Threshold) | D-serine 100 mg/kg | 11 | Standard Deviation 16.4 | log ratio | |
| Plasticity Improvement (Change in Tone Matching Threshold) | D-serine 120 mg/g | -0.05 | Standard Deviation 14.1 | log ratio | |
| Mismatch Negativity (MMN) | D-serine 80 mg/kg | -1.83 | Standard Deviation 2.1 | amplitude, micro volts | |
| Mismatch Negativity (MMN) | Placebo | -1.05 | Standard Deviation 1.6 | amplitude, micro volts | |
| Mismatch Negativity (MMN) | D-serine 100 mg/kg | -2.71 | Standard Deviation 1.7 | amplitude, micro volts | |
| Mismatch Negativity (MMN) | D-serine 120 mg/g | -0.56 | Standard Deviation 1.5 | amplitude, micro volts | |
| Theta Intertrial Coherence (Theta) | D-serine 80 mg/kg | .229 | Standard Deviation .06 | correlation coefficient (r) | |
| Theta Intertrial Coherence (Theta) | Placebo | .241 | Standard Deviation .06 | correlation coefficient (r) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | D-serine 80 mg/kg | 12 | |
| Overall Study | STARTED | D-serine 100 mg/kg | 12 | |
| Overall Study | STARTED | D-serine 120 mg/kg | 12 | |
| Overall Study | STARTED | Placebo | 9 | |
| Overall Study | COMPLETED | D-serine 80 mg/kg | 12 | |
| Overall Study | COMPLETED | D-serine 100 mg/kg | 11 | |
| Overall Study | COMPLETED | D-serine 120 mg/kg | 12 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | D-serine 80 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | D-serine 100 mg/kg | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | D-serine 80 mg/kg | 0 | 12 |
| Total, all-cause mortality | Placebo | 0 | 9 |
| Total, all-cause mortality | D-serine 100 mg/kg | 0 | 12 |
| Total, all-cause mortality | D-serine 120 mg/g | 0 | 12 |
| Total, other adverse events | D-serine 80 mg/kg | 0 | 12 |
| Total, other adverse events | Placebo | 0 | 9 |
| Total, other adverse events | D-serine 100 mg/kg | 0 | 12 |
| Total, other adverse events | D-serine 120 mg/g | 0 | 12 |
| Total, serious adverse events | D-serine 80 mg/kg | 0 | 12 |
| Total, serious adverse events | Placebo | 0 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03711500
GET https://conductscience.org/api/trials/v1/NCT03711500/registered