Trial · NCT02199743
Lurasidone Effects on Tissue Glutamate in Schizophrenia
NCT02199743, Phase 4, Completed, University of Texas Southwestern Medical Center; results first posted 2021-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lurasidone Effects on Tissue Glutamate in Schizophrenia. Trials, record NCT02199743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02199743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lurasidone Effects on Tissue Glutamate in Schizophrenia
- NCT number
- NCT02199743
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 35 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Lurasidone, Haloperidol, Perphenazine
- First posted
- 2014-07-24
- Last updated
- 2021-03-01
- Results first posted
- 2021-03-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cerebral Glutamate Levels | Baseline and 4 weeks | Mean values of cerebral glutamate levels was measured by high resolution 3T magnetic resonance spectroscopy (MRS) in the anterior cingulate cortex (ACC). Data were acquired from the dorsal anterior cingulate cortex (ACC) using single voxel localized PRESS (TE1, TE2) = (32, 65) ms with an 8-channel head coil in a 3T whole-body scanner (Philips Medical Systems). Voxel size was 30x20x15 mm3 (9 mL) and were placed over the bilateral anterior cingulate cortex (ACC). All values are normalized to water. More negative values represent less cerebral glutamate levels. |
| Secondary | Brief Assessments of Cognition in Schizophrenia Scores (BACS) | Baseline and 4 weeks | Mean of cognition was assessed by BACS, which measures neurocognitive function in schizophrenia. BACs is a validated, composite measure of cognition which is used in schizophrenia. It is composed of Verbal memory (range: 0-75), Working memory (range: 0-28), Motor speed (range: 0-100), Verbal Fluency (number of words generated), Information processing (range: 0-110) and Executive functions (range: 0-22). Higher z-scores indicate a better performance and outcome. BACS composite score are represented as z-scores which can be positive or negative. There is no minimum or maximum as this is a continuous measure. |
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 | Cerebral Glutamate Levels | Baseline and 4 weeks | Of the original 22 participants, only 15 have both Baseline and Week 4 scans to compare. | relative unit (RU as compared to water) | MEAN |
| SECONDARY | Brief Assessments of Cognition in Schizophrenia Scores (BACS) | Baseline and 4 weeks | Of the original 22 participants, only 15 have both Baseline and Week 4 to compare. | BACS composite score (z score) | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cerebral Glutamate Levels | Lurasidone | Baseline (week 0) | -1.434662171 | Standard Deviation 0.741430931 | relative unit (RU as compared to water) |
| Cerebral Glutamate Levels | Non-Lurasidone | Baseline (week 0) | -1.933853656 | Standard Deviation 1.005387144 | relative unit (RU as compared to water) |
| Cerebral Glutamate Levels | Lurasidone | week 4 | -1.412294235 | Standard Deviation 0.952600355 | relative unit (RU as compared to water) |
| Cerebral Glutamate Levels | Non-Lurasidone | week 4 | -1.838991525 | Standard Deviation 1.20411535 | relative unit (RU as compared to water) |
| Brief Assessments of Cognition in Schizophrenia Scores (BACS) | Lurasidone | Baseline (week 0) | -1.596573107 | Standard Deviation 0.929835487 | BACS composite score (z score) |
| Brief Assessments of Cognition in Schizophrenia Scores (BACS) | Non-Lurasidone | Baseline (week 0) | -1.933853656 | Standard Deviation 1.005387144 | BACS composite score (z score) |
| Brief Assessments of Cognition in Schizophrenia Scores (BACS) | Lurasidone | week 4 | -2.002433521 | Standard Deviation 1.596431421 | BACS composite score (z score) |
| Brief Assessments of Cognition in Schizophrenia Scores (BACS) | Non-Lurasidone | week 4 | -1.500292967 | Standard Deviation 1.477111055 | BACS composite score (z score) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lurasidone | 14 | |
| Overall Study | STARTED | Non-Lurasidone | 10 | |
| Overall Study | COMPLETED | Lurasidone | 14 | |
| Overall Study | COMPLETED | Non-Lurasidone | 8 | |
| Overall Study | NOT COMPLETED | Lurasidone | 0 | |
| Overall Study | NOT COMPLETED | Non-Lurasidone | 2 |
Source ClinicalTrials.gov
Adverse events14
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 | Sedation | Psychiatric disorders | Lurasidone (LUR) | 3 | 14 | 3 |
| other | Sedation | Psychiatric disorders | NONLUR | 4 | 8 | 4 |
| other | Nausea | Gastrointestinal disorders | Lurasidone (LUR) | 0 | 14 | 0 |
| other | Nausea | Gastrointestinal disorders | NONLUR | 2 | 8 | 2 |
| other | Insomnia | General disorders | Lurasidone (LUR) | 3 | 14 | 3 |
| other | Insomnia | General disorders | NONLUR | 0 | 8 | 0 |
| other | Restlessness | General disorders | Lurasidone (LUR) | 0 | 14 | 0 |
| other | Restlessness | General disorders | NONLUR | 3 | 8 | 3 |
| other | Stiffness in jaw | Musculoskeletal and connective tissue disorders | Lurasidone (LUR) | 2 | 14 | 2 |
| other | Stiffness in jaw | Musculoskeletal and connective tissue disorders | NONLUR | 0 | 8 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lurasidone (LUR) | ||
| Total, all-cause mortality | NONLUR | ||
| Total, other adverse events | Lurasidone (LUR) | 3 | 14 |
| Total, other adverse events | NONLUR | 4 | 8 |
| Total, serious adverse events | Lurasidone (LUR) | 1 | 14 |
| Total, serious adverse events | NONLUR | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39831535 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lurasidone (LUR) vs NONLUR: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Fluency | Secondary outcome |
Source ConductCognition
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/NCT02199743
GET https://conductscience.org/api/trials/v1/NCT02199743/registered