Relative Effectiveness of Schizophrenia Therapy Study

NCT01245348 | Completed

• 1 other identifier: REST
• Study Type: observational
• Target: 1,110
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Schizophrenia; Bipolar Disorder; atypical antipsychotic; adherence; cost effectiveness; pharmacogenetics; mental illness; SULT4A1

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (5)

• 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

  1 year

• 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

  1 year

• 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

  1 year

• 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

  1 year

• 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

  1 year

Study Arms (2)

Schizophrenia

Patient with schizophrenia

Genetic: SULT4A1-1 genetic test

Bipolar

Patient with bipolar disorder

Genetic: SULT4A1-1 genetic test

Interventions

SULT4A1-1 genetic test GENETIC

SULT4A1-1 haplotype result (+/-)

Bipolar; Schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medco Health Solutions, Inc.: lead
• SureGene, LLC: collaborator

Study Sites (1)

Medco Health Solutions, Inc.

Franklin Lakes, New Jersey, 07417, United States

Location

Related Publications (14)

• Nasrallah HA. The case for long-acting antipsychotic agents in the post-CATIE era. Acta Psychiatr Scand. 2007 Apr;115(4):260-7. doi: 10.1111/j.1600-0447.2006.00982.x.

  PMID: 17355516 BACKGROUND

• Stroup TS, McEvoy JP, Swartz MS, Byerly MJ, Glick ID, Canive JM, McGee MF, Simpson GM, Stevens MC, Lieberman JA. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development. Schizophr Bull. 2003;29(1):15-31. doi: 10.1093/oxfordjournals.schbul.a006986.

  PMID: 12908658 BACKGROUND

• Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.

  PMID: 16172203 BACKGROUND

• Sullivan PF, Lin D, Tzeng JY, van den Oord E, Perkins D, Stroup TS, Wagner M, Lee S, Wright FA, Zou F, Liu W, Downing AM, Lieberman J, Close SL. Genomewide association for schizophrenia in the CATIE study: results of stage 1. Mol Psychiatry. 2008 Jun;13(6):570-84. doi: 10.1038/mp.2008.25. Epub 2008 Mar 18.

  PMID: 18347602 BACKGROUND

• Liyou NE, Buller KM, Tresillian MJ, Elvin CM, Scott HL, Dodd PR, Tannenberg AE, McManus ME. Localization of a brain sulfotransferase, SULT4A1, in the human and rat brain: an immunohistochemical study. J Histochem Cytochem. 2003 Dec;51(12):1655-64. doi: 10.1177/002215540305101209.

  PMID: 14623933 BACKGROUND

• Minchin RF, Lewis A, Mitchell D, Kadlubar FF, McManus ME. Sulfotransferase 4A1. Int J Biochem Cell Biol. 2008;40(12):2686-91. doi: 10.1016/j.biocel.2007.11.010. Epub 2007 Dec 3.

  PMID: 18248844 BACKGROUND

• Hildebrandt MA, Carrington DP, Thomae BA, Eckloff BW, Schaid DJ, Yee VC, Weinshilboum RM, Wieben ED. Genetic diversity and function in the human cytosolic sulfotransferases. Pharmacogenomics J. 2007 Apr;7(2):133-43. doi: 10.1038/sj.tpj.6500404. Epub 2006 Jun 27.

  PMID: 16801938 BACKGROUND

• Lewis AG, Minchin RF. Lack of exonic sulfotransferase 4A1 mutations in controls and schizophrenia cases. Psychiatr Genet. 2009 Feb;19(1):53-5. doi: 10.1097/YPG.0b013e3283118776.

  PMID: 19125109 BACKGROUND

• Brennan MD, Condra J. Transmission disequilibrium suggests a role for the sulfotransferase-4A1 gene in schizophrenia. Am J Med Genet B Neuropsychiatr Genet. 2005 Nov 5;139B(1):69-72. doi: 10.1002/ajmg.b.30222.

  PMID: 16152568 BACKGROUND

• Condra JA, Neibergs H, Wei W, Brennan MD. Evidence for two schizophrenia susceptibility genes on chromosome 22q13. Psychiatr Genet. 2007 Oct;17(5):292-8. doi: 10.1097/YPG.0b013e3281ac2345.

  PMID: 17728668 BACKGROUND

• Meltzer HY, Brennan MD, Woodward ND, Jayathilake K. Association of Sult4A1 SNPs with psychopathology and cognition in patients with schizophrenia or schizoaffective disorder. Schizophr Res. 2008 Dec;106(2-3):258-64. doi: 10.1016/j.schres.2008.08.029. Epub 2008 Sep 27.

  PMID: 18823757 BACKGROUND

• Leucht S, Arbter D, Engel RR, Kissling W, Davis JM. How effective are second-generation antipsychotic drugs? A meta-analysis of placebo-controlled trials. Mol Psychiatry. 2009 Apr;14(4):429-47. doi: 10.1038/sj.mp.4002136. Epub 2008 Jan 8.

  PMID: 18180760 BACKGROUND

• Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, Moulis M, Aggarwal J. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry. 2005 Sep;66(9):1122-9. doi: 10.4088/jcp.v66n0906.

  PMID: 16187769 BACKGROUND

• Ascher-Svanum H, Zhu B, Faries D, Landbloom R, Swartz M, Swanson J. Time to discontinuation of atypical versus typical antipsychotics in the naturalistic treatment of schizophrenia. BMC Psychiatry. 2006 Feb 21;6:8. doi: 10.1186/1471-244X-6-8.

  PMID: 16504026 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Kelly Parsons, Ph.D.

  Medco Health Solutions, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Manager

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 22, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

US (1)