NCT00190749

Brief Summary

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2009

Completed
Last Updated

May 4, 2010

Status Verified

April 1, 2010

Enrollment Period

4.7 years

First QC Date

September 12, 2005

Results QC Date

June 3, 2009

Last Update Submit

April 26, 2010

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate

    Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]

    baseline and 12 weeks

Secondary Outcomes (29)

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.

    12 weeks

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)

    12 weeks

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.

    12 weeks

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.

    12 weeks

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.

    12 weeks

  • +24 more secondary outcomes

Study Arms (2)

Olanzapine

EXPERIMENTAL
Drug: olanzapine

Risperidone

ACTIVE COMPARATOR
Drug: risperidone

Interventions

olanzapineDRUG

5-20 mg, oral, capsules, daily, 12 weeks.

Also known as: LY170053, Zyprexa
Olanzapine
risperidoneDRUG

2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Risperidone

Eligibility Criteria

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

You may qualify if:

  • years old
  • Diagnosed with Schizophrenia or Schizoaffective disorder
  • Ability to visit the doctor's office for scheduled visits

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Have a body mass index (BMI) greater than 40
  • Have diabetes, heart disease or any other unstable illness
  • Have known positive human immunodeficiency virus (HIV)
  • Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Diego, California, 92161, United States

Location

Related Publications (1)

  • Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.

    PMID: 20840778DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

OlanzapineRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 4, 2010

Results First Posted

July 23, 2009

Record last verified: 2010-04

Locations

US(1)