NCT00205660

Brief Summary

This proposal aims to use well-validated methodologies such as dual energy x-ray absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine, risperidone or ziprasidone. We hypothesize that switching to aripiprazole treatment will induce improvements in total body adiposity, inflammation (e.g., high sensitivity C-reactive protein \[hsCRP\]), glucose metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and quetiapine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

January 15, 2019

Completed
Last Updated

January 15, 2019

Status Verified

July 1, 2018

Enrollment Period

4.5 years

First QC Date

September 12, 2005

Results QC Date

July 20, 2018

Last Update Submit

July 20, 2018

Conditions

SchizophreniaType 2 Diabetes Mellitus

Keywords

SchizophreniaObesityHyperglycemiaDyslipidemiaType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change in Total Body Fat (kg).

    This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.

    12 Weeks

  • Change in Whole Body Sensitivity (mg/kg/Min)

    This study hypothesized that switching to aripiprazole treatment will be associated with statistically significant improvements in whole body sensitivity (mg/kg/min) in comparison to chronic pretreatment with olanzapine.

    12 Weeks

Study Arms (2)

Stayers

OTHER

Subjects are randomized to stay on their current antipsychotic.

Other: Stayers

Switchers

OTHER

Subjects are randomized to switch to aripiprazole from their current antipsychotic.

Other: Switchers

Interventions

StayersOTHER

Participants remain on their current antipsychotic.

Stayers
SwitchersOTHER

Subjects are randomized to switch to aripiprazole from their current antipsychotic.

Switchers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient meets DSM-IV criteria for Schizophrenia
  • years of age or older
  • Able to give informed consent
  • Treated with olanzapine, quetiapine, risperidone or ziprasidone for greater than or equal to 3 months prior to enrollment

You may not qualify if:

  • pregnant or breastfeeding women will be excluded
  • Meets DSM-IV criteria for substance abuse or dependence within past 6 months
  • involuntary legal status (as per Missouri law)
  • any serious medical disorder that may confound assessment of symptoms
  • subjects taking prescription medications except psychotropic meds
  • meets DSM-IV criteria for Mental Retardation (mild or worse)
  • Subjects taking tricyclic antidepressants or mood stabilizers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1.

    PMID: 11806485BACKGROUND

MeSH Terms

Conditions

SchizophreniaDiabetes Mellitus, Type 2ObesityHyperglycemiaDyslipidemias

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism Disorders

Results Point of Contact

Title
Michael Yingling
Organization
Washington University
yinglinm@wustl.edu
5735791412

Study Officials

  • John W. Newcomer, MD

    Washington University School of Medicine and Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 15, 2019

Results First Posted

January 15, 2019

Record last verified: 2018-07

Locations

US(1)