Status:
COMPLETED
Relative Effectiveness of Schizophrenia Therapy Study
Lead Sponsor:
Medco Health Solutions, Inc.
Collaborating Sponsors:
SureGene, LLC
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to validate that SULT4A1-1 status stratification improves responses to atypical antipsychotics in schizophrenia and to extend these findings into bipolar disorder.
Detailed Description
The total economic burden for schizophrenia (SZ) in the U.S. is estimated to be more than $60 billion annually. A large contributor to the economic burden of this and other chronic mental disorders, i...
Eligibility Criteria
Inclusion
- Subjects ≥ 18 years of age
- Subjects with either a confirmed diagnosis of schizophrenia or bipolar disorder or subjects with self reported schizophrenia or bipolar disorder
- Subjects who were/are new to therapy for olanzapine, risperidone, quetiapine or ziprasidone
- Subjects who are willing and able to provide informed consent
Exclusion
- Subjects initially prescribed less than the generally accepted minimally effective dose of the drugs under study
- Subjects with Major Depressive Disorder (MDD) or another psychotic disorder other than schizophrenia or bipolar disorder
- Subjects with catatonic schizophrenia
- Subjects with moderate to severe mental retardation
- Subjects that refuse to participate in the study
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1110 Patients enrolled
Trial Details
Trial ID
NCT01245348
Start Date
December 1 2010
End Date
December 1 2012
Last Update
February 25 2013
Active Locations (1)
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1
Medco Health Solutions, Inc.
Franklin Lakes, New Jersey, United States, 07417