Phase 4 N=24 Randomized Quadruple-blind Treatment

Lurasidone Effects on Tissue Glutamate in Schizophrenia

Schizophrenia · Schizoaffective Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02199743 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Mar 2021

Primary outcome: Primary: Cerebral Glutamate Levels — -1.434662171; -1.933853656; -1.412294235; -1.838991525 relative unit (RU as compared to water)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lurasidone (Drug); Haloperidol (Drug); Perphenazine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Cerebral Glutamate Levels	-1.434662171; -1.933853656; -1.412294235; -1.838991525	—
SECONDARY Brief Assessments of Cognition in Schizophrenia Scores (BACS)	-1.596573107; -1.933853656; -2.002433521; -1.500292967	—

Summary

24 individuals with schizophrenia or schizoaffective disorders, who are currently considered stable, will be recruited, screened for entry criteria into a blinded study with a 4-week randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related outcomes with lurasidone as compared to haloperidol and perphenazine.

Eligibility Criteria

Inclusion Criteria

Subject at least 18 years old
Subject meets criteria diagnosis of schizophrenia or schizoaffective disorder.
Subject is not pregnant and is not planning pregnancy within the projected duration of the study.
Female subject who is of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study
Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
Eyesight corrected to 20-40 or better
Able to read, speak, and understand English*

Exclusion Criteria

Any medications being used as mood stabilizers (i.e., anticonvulsants)
Subject currently has a clinically significant medical condition(s) that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
Subject demonstrates evidence of acute/chronic hepatitis which is clinically significant
Subject has a history of malignancy 200 ng/mL at screening
Subject has a history or presence of abnormal ECG which is clinically significant
Subject has a history of hypersensitivity to more than two distinct chemical classes of drug (e.g., sulfas and penicillins).
Subjects have received depot neuroleptics within 12 weeks prior to randomization.
Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine within 4 months of randomization.
Subject does not have a stable residence for the 3 months prior to randomization.
Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study.
Subject has received electroconvulsive therapy (ECT) within 90 days prior to
Subject has been randomized in a prior clinical trial of lurasidone.
History of serious head injury with unconsciousness for >30 minutes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02199743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.