Phase 4
Completed N=24
Lurasidone Effects on Tissue Glutamate in Schizophrenia
Source: ClinicalTrials.gov NCT02199743 ↗Enrolled (actual)
24
Serious AEs
4.6%
Results posted
Mar 2021
Primary outcomePrimary: Cerebral Glutamate Levels — -1.434662171; -1.933853656; -1.412294235; -1.838991525 relative unit (RU as compared to water)
◆ Published Evidence
Not yet cited
0citations
Lurasidone versus typical antipsychotics for schizophrenia.
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.
Linked Publications
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Lurasidone versus typical antipsychotics for schizophrenia.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02199743) and the linked publication. 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. Informational only — not medical advice.