Lurasidone Effects on Tissue Glutamate in Schizophrenia

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Sunovion
• Treatments: Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride; Perphenazine

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 < 5 years prior

• Subject has a history of neuroleptic malignant syndrome (NMS).

• Subject has a history of alcohol or substance abuse within 3 months prior to screening or alcohol or substance dependence within 12 months prior to screening

• Subject tests positive for drugs of abuse at screening. In the event a subject tests positive for cannabis, the investigator will evaluate the subject's ability to abstain from cannabis during the study.

• Subjects diagnosed with type 1 diabetes

• Subject has a prolactin concentration > 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