Status:

COMPLETED

Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)

Lead Sponsor:

Eli Lilly and Company

Conditions:

Schizophrenia

Schizoaffective Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Patients must):
  • Be at least 18 years old
  • Have gained weight while taking olanzapine
  • Be able to visit the doctor's office seven times over 4 months (17 weeks)
  • Exclusion Criteria (Patients must NOT):
  • Have started a weight loss program within the last 8 weeks
  • Have an illness that might affect patient's weight during the study
  • Have an allergy to phenylalanine, mannitol or saccharine
  • Be taking any medication (except for olanzapine) that might affect patient's weight

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2007

    Estimated Enrollment :

    149 Patients enrolled

    Trial Details

    Trial ID

    NCT00303602

    Start Date

    March 1 2006

    End Date

    December 1 2007

    Last Update

    June 10 2009

    Active Locations (21)

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    Page 1 of 6 (21 locations)

    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.

    Escondido, California, United States, 92025

    2

    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.

    Garden Grove, California, United States, 92845

    3

    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.

    National City, California, United States, 91950

    4

    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.

    Orange, California, United States, 92868