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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryCerebral Glutamate LevelsBaseline 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.
SecondaryBrief 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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCerebral Glutamate LevelsBaseline and 4 weeksOf the original 22 participants, only 15 have both Baseline and Week 4 scans to compare.relative unit (RU as compared to water)MEAN
SECONDARYBrief Assessments of Cognition in Schizophrenia Scores (BACS)Baseline and 4 weeksOf the original 22 participants, only 15 have both Baseline and Week 4 to compare.BACS composite score (z score)MEAN

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Cerebral Glutamate LevelsLurasidoneBaseline (week 0)-1.434662171Standard Deviation 0.741430931relative unit (RU as compared to water)
Cerebral Glutamate LevelsNon-LurasidoneBaseline (week 0)-1.933853656Standard Deviation 1.005387144relative unit (RU as compared to water)
Cerebral Glutamate LevelsLurasidoneweek 4-1.412294235Standard Deviation 0.952600355relative unit (RU as compared to water)
Cerebral Glutamate LevelsNon-Lurasidoneweek 4-1.838991525Standard Deviation 1.20411535relative unit (RU as compared to water)
Brief Assessments of Cognition in Schizophrenia Scores (BACS)LurasidoneBaseline (week 0)-1.596573107Standard Deviation 0.929835487BACS composite score (z score)
Brief Assessments of Cognition in Schizophrenia Scores (BACS)Non-LurasidoneBaseline (week 0)-1.933853656Standard Deviation 1.005387144BACS composite score (z score)
Brief Assessments of Cognition in Schizophrenia Scores (BACS)Lurasidoneweek 4-2.002433521Standard Deviation 1.596431421BACS composite score (z score)
Brief Assessments of Cognition in Schizophrenia Scores (BACS)Non-Lurasidoneweek 4-1.500292967Standard Deviation 1.477111055BACS composite score (z score)

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDLurasidone14
Overall StudySTARTEDNon-Lurasidone10
Overall StudyCOMPLETEDLurasidone14
Overall StudyCOMPLETEDNon-Lurasidone8
Overall StudyNOT COMPLETEDLurasidone0
Overall StudyNOT COMPLETEDNon-Lurasidone2

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherSedationPsychiatric disordersLurasidone (LUR)3143
otherSedationPsychiatric disordersNONLUR484
otherNauseaGastrointestinal disordersLurasidone (LUR)0140
otherNauseaGastrointestinal disordersNONLUR282
otherInsomniaGeneral disordersLurasidone (LUR)3143
otherInsomniaGeneral disordersNONLUR080
otherRestlessnessGeneral disordersLurasidone (LUR)0140
otherRestlessnessGeneral disordersNONLUR383
otherStiffness in jawMusculoskeletal and connective tissue disordersLurasidone (LUR)2142
otherStiffness in jawMusculoskeletal and connective tissue disordersNONLUR080

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityLurasidone (LUR)
Total, all-cause mortalityNONLUR
Total, other adverse eventsLurasidone (LUR)314
Total, other adverse eventsNONLUR48
Total, serious adverse eventsLurasidone (LUR)114
Total, serious adverse eventsNONLUR08

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
39831535DERIVED

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

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Verbal FluencySecondary outcome

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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