Schizophrenia Clinical Trial
Official title:
Relative Effectiveness of Schizophrenia Therapy (REST) Study
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.
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, including bipolar disorder (BPD), is the exacerbation of symptoms and
disability due to lack of drug efficacy. For these disorders, clinicians typically choose a
first line antipsychotic therapy without the support of a diagnostic tool; often, patients
are switched to another drug after less than six months of treatment due to what is
perceived by patients and clinicians as both insufficient efficacy and unacceptable side
effects.
Originally, the sulfotransferase family 4A, member 1 (SULT4A1) gene was selected as a
biomarker of interest in SZ based on results showing associations between the gene and
disease severity. Later on, SULT4A1 gene status was also associated with better efficacy of
atypical antipsychotic (e.g. Zyprexa® (olanzapine) and Risperdal® (risperidone)), with
respect to both time to discontinuation and quantitative measures of clinical improvement.
In this prospectively designed, non-randomized retrospective study, we will recruit and
genotype subjects with schizophrenia or bipolar disorder that were/are new to therapy for
any of the four drugs under evaluation. By looking at retrospective and prospective
longitudinal medical and pharmacy data stored within the integrated claims database, we will
validate the association of the SULT4A1 gene to the efficacy of selected atypical
antipsychotic therapies.
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