NCT00752960

Brief Summary

The purpose of this study is to assess patients treated with the antipsychotics aripiprazole (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), or ziprasidone (Geodon®) and to identify genetic variations more commonly found in individuals who develop diabetic metabolic signs and symptoms, which include changes in blood lipids, blood glucose, blood pressure, and body weight.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

2.9 years

First QC Date

September 12, 2008

Last Update Submit

September 12, 2008

Conditions

Psychoses

Keywords

single nucleotide polymorphism, SNP, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • diabetic metabolic symptoms (DiMS): body weight, body mass index, waist circumference, blood pressure, triglycerides, total, LDL, and HDL cholesterol, blood glucose

    after treatment with antipsychotic medication(s) for => 3 months

Study Arms (5)

A

Patients receiving olanzapine

B

patients receiving risperidone

C

Patients receiving quetiapine

D

Patients receiving aripiprazole

E

patients receiving ziprasidone

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients treated for psychoses

You may qualify if:

  • receiving atypical antipsychotic therapy (olanzapine, aripiprazole, quetiapine, risperidone, or ziprasidone) for 3 months
  • who have taken \>50% of the prescribed dose for the last month.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hartford Hospital Institute of Living

Hartford, Connecticut, 06106, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40508, United States

RECRUITING

Related Publications (4)

  • Ruano G, Blair CL, Bower B, Windemuth A, Kocherla M, Aleman Y, Pearlson G, Goethe JW, Schwartz HI. Somatic complications of psychotropic medications in a patient with multiple CYP2 drug metabolism deficiencies. Conn Med. 2007 Apr;71(4):197-200.

    PMID: 17487003BACKGROUND

  • de Leon J, Susce MT, Johnson M, Hardin M, Pointer L, Ruano G, Windemuth A, Diaz FJ. A clinical study of the association of antipsychotics with hyperlipidemia. Schizophr Res. 2007 May;92(1-3):95-102. doi: 10.1016/j.schres.2007.01.015. Epub 2007 Mar 8.

    PMID: 17346932BACKGROUND

  • Ruano G, Goethe JW, Caley C, Woolley S, Holford TR, Kocherla M, Windemuth A, de Leon J. Physiogenomic comparison of weight profiles of olanzapine- and risperidone-treated patients. Mol Psychiatry. 2007 May;12(5):474-82. doi: 10.1038/sj.mp.4001944. Epub 2007 Jan 2.

    PMID: 17199131BACKGROUND

  • Windemuth A, de Leon J, Goethe JW, Schwartz HI, Woolley S, Susce M, Kocherla M, Bogaard K, Holford TR, Seip RL, Ruano G. Validation of candidate genes associated with cardiovascular risk factors in psychiatric patients. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Mar 30;36(2):213-9. doi: 10.1016/j.pnpbp.2011.08.001. Epub 2011 Aug 6.

    PMID: 21851846DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from whole blood

MeSH Terms

Conditions

Psychotic DisordersMetabolic Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gualberto Ruano, MD, PhD

    Genomas, Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Woolley, PhD

CONTACT

860-545-7329swoolle@harthosp.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 16, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

US(2)