Trial · NCT01911676
Translational Neuroscience Optimization of GlyT1 Inhibitor
NCT01911676, Phase 2, Completed, Yale University; results first posted 2023-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Translational Neuroscience Optimization of GlyT1 Inhibitor. Trials, record NCT01911676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01911676
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Translational Neuroscience Optimization of GlyT1 Inhibitor
- NCT number
- NCT01911676
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Cognitive Impairments Associated With Schizophrenia
- Interventions
- PF-03463275, Placebo
- First posted
- 2013-07-30
- Last updated
- 2024-08-19
- Results first posted
- 2023-02-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm. | To test the efficacy of PF-03463275 on cognitive test performance specifically, the MCCB composite score was used. The MCCB consists of 10 tests and provides standard scores and percentiles for each of seven cognitive domains and an overall composite score. Domains assessed include: speed of processing, attention/vigilance, working memory (verbal and visual), verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB overall composite score is presented as a T-score. The range of T-scores is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning. |
| Secondary | Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275 | Change from Baseline at approximately 1 week | To determine whether PF-03463275 impacts symptom domain scores and visual event related potentials (ERPs), analogous to long-term potentiation (LTP) with PF-03463275 treatment. A more positive value reflects a better outcome - there is no established range to report. A Z-score of 0 indicates the mean score. A positive z-score indicates the mean is higher than average. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm. | The 3 arms that subjects can be randomized to are: A) Period 1: Active 60mg PF-03463275 then Period 2: Placebo; B) Period 1: Active 40mg PF-03463275 then Period 2: Placebo; C) Period 1: Placebo then Period 2: Active 60mg or 40mg PF-03463275. The following completed both period 1 and period 2 of the study: A) 15 subjects; B) 21 subjects; and C) 18 subjects (11 randomized to period 1-placebo/period 2-60mg PF-03463275; and 8 randomized to period 1-placebo/period 2-40mg PF-03463275). | score on scale | MEAN |
| SECONDARY | Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275 | Change from Baseline at approximately 1 week | Noncompleters and unusable data of completers led to differences between the total number of participants and the sample for this outcome measure. | Mean LTP Standard (z) Score +1 SE | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | PF-03463275 Active Dose #1 | Pre-Dose Period 1 | 28.15 | Standard Deviation 13.54 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | PF-03463275 Active Dose #2 | Pre-Dose Period 1 | 25.22 | Standard Deviation 13.86 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Placebo, Active Dose #1 | Pre-Dose Period 1 | 31.71 | Standard Deviation 17.24 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Placebo, Active Dose #2 | Pre-Dose Period 1 | 28.3 | Standard Deviation 17.7 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | PF-03463275 Active Dose #1 | Post-Dose Period 1 | 29.25 | Standard Deviation 12.38 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | PF-03463275 Active Dose #2 | Post-Dose Period 1 | 26.33 | Standard Deviation 14.96 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Placebo, Active Dose #1 | Post-Dose Period 1 | 30.86 | Standard Deviation 17.45 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | Placebo, Active Dose #2 | Post-Dose Period 1 | 30.11 | Standard Deviation 14.75 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | PF-03463275 Active Dose #1 | Pre-Dose Period 2 | 29.39 | Standard Deviation 12.68 | score on scale |
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | PF-03463275 Active Dose #2 | Pre-Dose Period 2 | 27.11 | Standard Deviation 12.46 | score on scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 of Study | STARTED | PF-03463275 Active Dose #1 | 23 | |
| Period 1 of Study | STARTED | PF-03463275 Active Dose #2 | 23 | |
| Period 1 of Study | STARTED | Placebo, Active Dose #1 | 12 | |
| Period 1 of Study | STARTED | Placebo, Active Dose #2 | 13 | |
| Period 1 of Study | COMPLETED | PF-03463275 Active Dose #1 | 17 | |
| Period 1 of Study | COMPLETED | PF-03463275 Active Dose #2 | 21 | |
| Period 1 of Study | COMPLETED | Placebo, Active Dose #1 | 11 | |
| Period 1 of Study | COMPLETED | Placebo, Active Dose #2 | 10 | |
| Period 1 of Study | NOT COMPLETED | PF-03463275 Active Dose #1 | 6 | |
| Period 1 of Study | NOT COMPLETED | PF-03463275 Active Dose #2 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased Anxiety | Psychiatric disorders | PF-03463275 Active Dose #1 | 2 | 34 | 2 |
| other | Increased Anxiety | Psychiatric disorders | PF-03463275 Active Dose #2 | 1 | 33 | 1 |
| other | Increased Anxiety | Psychiatric disorders | Placebo | 2 | 63 | 2 |
| other | Increased Anxiety | Psychiatric disorders | Washout | 0 | 59 | 0 |
| other | Blurry Vision | General disorders | PF-03463275 Active Dose #1 | 0 | 34 | 0 |
| other | Blurry Vision | General disorders | PF-03463275 Active Dose #2 | 2 | 33 | 2 |
| other | Blurry Vision | General disorders | Placebo | 2 | 63 | 2 |
| other | Blurry Vision | General disorders | Washout | 0 | 59 | 0 |
| other | Sleep Disturbance | General disorders | PF-03463275 Active Dose #1 | 0 | 34 | 0 |
| other | Sleep Disturbance | General disorders | PF-03463275 Active Dose #2 | 2 | 33 | 2 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03463275 Active Dose #1 | 0 | 34 |
| Total, all-cause mortality | PF-03463275 Active Dose #2 | 0 | 33 |
| Total, all-cause mortality | Placebo | 0 | 63 |
| Total, all-cause mortality | Washout | 0 | 59 |
| Total, other adverse events | PF-03463275 Active Dose #1 | 13 | 34 |
| Total, other adverse events | PF-03463275 Active Dose #2 | 13 | 33 |
| Total, other adverse events | Placebo | 9 | 63 |
| Total, other adverse events | Washout | 7 | 59 |
| Total, serious adverse events | PF-03463275 Active Dose #1 | 0 | 34 |
| Total, serious adverse events | PF-03463275 Active Dose #2 | 2 | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37141764 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH3TR000960 | Translational Neuroscience Optimization of GlyT1 Inhibitor | KRYSTAL, JOHN H. | YALE UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2014 to 2017 |
Source NIH RePORTER
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/NCT01911676
GET https://conductscience.org/api/trials/v1/NCT01911676/results?page=2