CClinicalTrials.gg
Status unknownNCT00752960DIMSUpdated Sep 16, 2008

DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics

An observational study in Psychoses, sponsored by Genomas, Inc. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2008-09-16.

Sponsored by Genomas, Inc · Observational

The sponsor has not verified this record recently (last verified Sep 2008), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years to 59 Years
Sex
All
01

Study 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.

Read the detailed description

As many as 30% of psychiatric patients experience weight gain, central deposition of fat, dyslipidemia, increased blood glucose and hypertension--diabetic metabolic symptoms--upon treatment with atypical antipsychotic medication. As a result, cardiovascular disease risk is significantly increased.

The long-term goal of this collaborative study is to identify, for each individual atypical antipsychotic (AAP) medication, the gene variations associated with elevated risk of diabetic metabolic symptoms (DiMS). If such genes are identified, in the future genetic testing may help mental health care professionals choose treatment while minimizing the risk of undesirable side effects of antipsychotics. We propose to develop a novel product termed "Physiotype" to deliver personalized information for each patient on the drug specific risks among aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. The Physiotype consists of a multi-gene ensemble of single nucleotide polymorphisms (SNPs) that, interpreted with a biomathematical algorithm, may explain most of the inter-individual differences in DiMS among the 5 AAPs. If this study does identify related genes, genetic tests will be developed to provide patients and health care professionals with tools to identify those patients who are at risk of developing adverse metabolic side effects to antipsychotics.

02

Conditions studied

  • Psychoses

Browse trials for

Keywords

  • single nucleotide polymorphism, SNP, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome
03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 150 across 245 observational studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

Genomas, Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated for psychoses

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • A

    Patients receiving olanzapine

  • B

    patients receiving risperidone

  • C

    Patients receiving quetiapine

  • D

    Patients receiving aripiprazole

  • E

    patients receiving ziprasidone

06

What researchers measure

Primary outcomes

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

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

07

Study locations

2 of 2 sites recruiting
  • Hartford Hospital Institute of Living
    Hartford, Connecticut 06106, United States
    Recruiting
  • University of Kentucky
    Lexington, Kentucky 40508, United States
    • Jose de Leon, MD · Contact · jdeleon@uky.edu · 859-246-7563
    • Jose de Leon, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 17487003 ↗
  • 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. PubMed 17346932 ↗
  • 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. PubMed 17199131 ↗
  • 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. PubMed 21851846 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00752960
Lead sponsor
Genomas, Inc
Collaborators
Hartford Hospital, University of Kentucky
First posted
Sep 16, 2008
Start date
Jan 2007
Primary completion
Dec 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Sep 16, 2008

Study contacts

Steven Woolley, PhD
Contact
swoolle@harthosp.org
860-545-7329
Gualberto Ruano, MD, PhD
principal investigator · Genomas, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion