Lurasidone Effects on Tissue Glutamate in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Lurasidone; Haloperidol; Perphenazine
Intervention description: Compare to haloperidol and perphenazine; Compare to lurasidone; Compare to lurasidone
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride; Perphenazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective; cognition; lurasidone; Latuda

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 < 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