Relative Effectiveness of Schizophrenia Therapy Study (REST)

Medco Health Solutions

Status

Completed

Conditions

Schizophrenia

Bipolar Disorder

Treatments

Genetic: SULT4A1-1 genetic test

Study type

Observational

Funder types

Industry

Identifiers

NCT01245348

REST (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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