NCT00338949

Brief Summary

This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Jun 2006

Typical duration 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

June 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
3.5 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
10.7 years until next milestone

Results Posted

Study results publicly available

August 21, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

3.5 years

First QC Date

June 16, 2006

Results QC Date

May 17, 2016

Last Update Submit

October 5, 2020

Conditions

SchizophreniaMetabolic Syndrome XInsulin Resistance

Keywords

ZiprasidoneOlanzapineRisperidoneSchizoaffective DisorderInsulin SensitivityVisceral AdiposityMetabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min)

    As measured by frequently sampled intravenous glucose tolerance testing (units: 1/mU/L) x 1/Min)

    Measured at Baseline and Week 26

  • Change in Visceral Fat Mass From Baseline to Week 26

    CT measured change in visceral fat mass from baseline to week 26 (mm\^3)

    Baseline and Week 26

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone

Drug: Control

Switch

EXPERIMENTAL

Participants who enter on risperidone or olanzapine and switch to ziprasidone

Drug: Switch

Interventions

SwitchDRUG

Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.

Also known as: ziprasidone
Switch
ControlDRUG

Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.

Also known as: risperidone, olanzapine
Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Currently receiving antipsychotic therapy with risperidone or olanzapine
  • Overweight

You may not qualify if:

  • Diagnosis of diabetes
  • Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
  • Refractory schizophrenia or schizoaffective disorder
  • Currently receiving therapy with clozapine
  • No stable residence and phone number for 90 days prior to study entry
  • Prior unsuccessful treatment with ziprasidone
  • Intolerance to ziprasidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

  • McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. doi: 10.1016/j.schres.2005.07.014. Epub 2005 Aug 30.

    PMID: 16137860BACKGROUND

MeSH Terms

Conditions

SchizophreniaMetabolic SyndromeInsulin ResistancePsychotic Disorders

Interventions

ziprasidoneRisperidoneOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Open label, stable patients.

Results Point of Contact

Title
Jonathan Meyer MD
Organization
UCSD/VA San Diego
jmmeyer@ucsd.edu
8589640777

Study Officials

  • Jonathan M. Meyer, MD

    University of California, San Diego & VA San Diego Healthcare System

    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
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 30, 2020

Results First Posted

August 21, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)