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SchizophreniaRESTNCT01245348

Relative Effectiveness of Schizophrenia Therapy Study

An observational study of Schizophrenia and Bipolar Disorder, run by Medco Health Solutions, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia, Bipolar Disorder
What is being tested?
SULT4A1-1 genetic test
How many people
1,110 participants
Where
1 siteUnited States
Study dates
Dec 2010to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medco Health Solutions, Inc.

    Franklin Lakes, New Jersey, 07417

Other trials in United States

About this study

Official title: Relative Effectiveness of Schizophrenia Therapy (REST) Study

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.

Read the 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.

Being tested
SULT4A1-1 genetic test
Keywords
Schizophrenia, Bipolar Disorder, atypical antipsychotic, adherence, cost effectiveness, pharmacogenetics, mental illness, SULT4A1
Medical subject headings
Schizophrenia, Bipolar Disorder, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SULT4A1-1 genetic testGenetic

    SULT4A1-1 haplotype result (+/-)

Study groups in NCT01245348
Study groupRoleWhat they receive
SchizophreniaPatient with schizophrenia
Receives: Genetic: SULT4A1-1 genetic test
BipolarPatient with bipolar disorder
Receives: Genetic: SULT4A1-1 genetic test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (5)

  1. 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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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

    Measured: 1 year

  5. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
1,110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245348
Sponsor's protocol ID
REST
Acronym
REST
Status last verified
Feb 2013
First submitted
18 Nov 2010
Last updated
25 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17355516

  • 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.

    PubMed 12908658

  • 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.

    PubMed 16172203

  • 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.

    PubMed 18347602

  • 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.

    PubMed 14623933

  • 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.

    PubMed 18248844

  • 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.

    PubMed 16801938

  • 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.

    PubMed 19125109

  • 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.

    PubMed 16152568

  • 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.

    PubMed 17728668

  • 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.

    PubMed 18823757

  • 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.

    PubMed 18180760

  • 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.

    PubMed 16187769

  • 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.

    PubMed 16504026

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Bipolar Disorder, run by Medco Health Solutions, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01245348, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.

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