Clinical trial NCT01245348: Relative Effectiveness of Schizophrenia Therapy Study
Official title: Relative Effectiveness of Schizophrenia Therapy (REST) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Schizophrenia
Bipolar Disorder
atypical antipsychotic
adherence
cost effectiveness
pharmacogenetics
mental illness
SULT4A1
Lead sponsor: Medco Health Solutions, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SureGene, LLC
First posted: 2010-11-22
Enrollment: 1110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥18y/o) with either a schizophrenia or bipolar disorder diagnosis and were/are new to therapy for olanzapine, risperidone, quetiapine or ziprasidone.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess differences in time to discontinuation (TTD) of olanzapine and risperidone therapy between schizophrenia and bipolar disorder subjects (independently) who are SULT4A1-1 haplotype-positive and who are SULT4A1-1 haplotype-negative
timeFrame: 1 year
Secondary outcomes:
measure: Assess differences in time to discontinuation (TTD) of quetiapine and ziprasidone therapy between schizophrenia and bipolar disorder subjects (independently) who are SULT4A1-1 haplotype-positive and who are SULT4A1-1 haplotype-negative
timeFrame: 1 year
measure: For each drug under study assess hospitalization rates for psychiatric illness between schizophrenia and bipolar disorder subjects (independently) who are SULT4A1-1 haplotype-positive and who are SULT4A1-1 haplotype-negative
timeFrame: 1 year
measure: Evaluate whether there are differences in time to discontinuation (TTD) of each drug under study between schizophrenia and bipolar disorder subjects (combined) who are SULT4A1-1 haplotype-positive and who are SULT4A1-1 haplotype-negative
timeFrame: 1 year
measure: Evaluate whether there are differences in overall medical spending between schizophrenia and bipolar disorder subjects (independently and combined) who are SULT4A1-1 haplotype-positive and who are SULT4A1-1 haplotype-negative for each drug under study
timeFrame: 1 year
measure: Evaluate whether there are differences in adherence to each drug under study between schizophrenia and bipolar disorder subjects (independently and combined) who are SULT4A1-1 haplotype-positive and who are SULT4A1-1 haplotype-negative
timeFrame: 1 year
Other outcomes:
Locations:
city: Franklin Lakes
country: United States
facility: Medco Health Solutions, Inc.
state: New Jersey
Study officials:
affiliation: Medco Health Solutions, Inc.
name: Kelly Parsons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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