NCT01245348

Relative Effectiveness of Schizophrenia Therapy Study

Relative Effectiveness of Schizophrenia Therapy (REST) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,110 (actual)
• Sponsor: Medco Health Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Schizophrenia
• Bipolar Disorder

Interventions

Type	Name	Description
GENETIC	SULT4A1-1 genetic test	SULT4A1-1 haplotype result (+/-)

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-11-22
• Last updated: 2013-02-25

Locations

1 site across 1 country: United States