Status:
COMPLETED
Lurasidone Effects on Tissue Glutamate in Schizophrenia
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
At study start all volunteers will be discontinued from their current antipsychotic drug (APD) and switched to haloperidol 4mg for 5 days. At the end of this discontinuation period, all baseline sympt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02199743
Start Date
February 1 2013
End Date
June 1 2016
Last Update
March 1 2021
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390