Relative Effectiveness of Schizophrenia Therapy Study (REST)

This study has been completed.
Sponsor:
Collaborator:
SureGene, LLC
Information provided by (Responsible Party):
Kelly Parsons, Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT01245348
First received: November 18, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Schizophrenia
Bipolar Disorder
Genetic: SULT4A1-1 genetic test

Study Type: Observational
Official Title: Relative Effectiveness of Schizophrenia Therapy (REST) Study

Resource links provided by NLM:


Further study details as provided by Medco Health Solutions, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

One milliliter of saliva will be self collected by study subjects for genetic testing.


Enrollment: 1110
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Schizophrenia
Patient with schizophrenia
Genetic: SULT4A1-1 genetic test
SULT4A1-1 haplotype result (+/-)
Bipolar
Patient with bipolar disorder
Genetic: SULT4A1-1 genetic test
SULT4A1-1 haplotype result (+/-)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245348

Locations
United States, New Jersey
Medco Health Solutions, Inc.
Franklin Lakes, New Jersey, United States, 07417
Sponsors and Collaborators
Medco Health Solutions, Inc.
SureGene, LLC
Investigators
Principal Investigator: Kelly Parsons, Ph.D. Medco Health Solutions, Inc.
  More Information

Publications:

Responsible Party: Kelly Parsons, Senior Research Manager, Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier: NCT01245348     History of Changes
Other Study ID Numbers: REST
Study First Received: November 18, 2010
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medco Health Solutions, Inc.:
Schizophrenia
Bipolar Disorder
atypical antipsychotic
adherence
cost effectiveness
pharmacogenetics
mental illness
SULT4A1

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders

ClinicalTrials.gov processed this record on September 22, 2014