NCT00088478

Brief Summary

Key objectives of this clinical study are to:

  • Determine how well intramuscular (IM) olanzapine depot works compared to placebo
  • Evaluate the safety and tolerability of IM olanzapine depot compared to placebo
  • Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
402

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
3 countries

37 active sites

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, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

June 12, 2007

Status Verified

June 1, 2007

First QC Date

July 26, 2004

Last Update Submit

June 11, 2007

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Demonstrate superiority of IM olanzapine depot 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks dosages compared with placebo in the treatment of patients with schizophrenia

Secondary Outcomes (7)

  • To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-I

  • To determine the earliest time point at which 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot show superior clinical improvement compared with placebo

  • To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-S

  • To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in terms of change in PANSS Positive, PANSS Negative and PANSS General Psychopathology subscales

  • To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in change from baseline to endpoint in quality of life

  • +2 more secondary outcomes

Interventions

Intramuscular Olanzapine DepotDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have schizophrenia and be experiencing a psychotic episode
  • Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
  • Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
  • Female patients must not be pregnant or breast-feeding
  • Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia

You may not qualify if:

  • Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
  • Treatment with clozapine within 4 weeks prior to visit 1
  • DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days
  • Treatment with remoxipride within 6 months (180 days) prior to visit 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

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 hrs, EST), or speak with your personal physician.

National City, California, United States

Location

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Orange, California, United States

Location

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Rosemead, California, United States

Location

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San Diego, California, United States

Location

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Santa Ana, California, United States

Location

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Denver, Colorado, United States

Location

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Washington D.C., District of Columbia, United States

Location

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Bradenton, Florida, United States

Location

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Honolulu, Hawaii, United States

Location

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Chicago, Illinois, United States

Location

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Hoffman Estates, Illinois, United States

Location

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Lake Charles, Louisiana, United States

Location

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Baltimore, Maryland, United States

Location

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Rockville, Maryland, United States

Location

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Saint Louis, Michigan, United States

Location

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Kansas City, Missouri, United States

Location

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Las Vegas, Nevada, United States

Location

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Reno, Nevada, United States

Location

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Clementon, New Jersey, United States

Location

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Lawrence, New York, United States

Location

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New York, New York, United States

Location

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Rochester, New York, United States

Location

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Staten Island, New York, United States

Location

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Beachwood, Ohio, United States

Location

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 hrs, EST), or speak with your personal physician.

Chagrin Falls, Ohio, United States

Location

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Oklahoma City, Oklahoma, United States

Location

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Norristown, Pennsylvania, United States

Location

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Philadelphia, Pennsylvania, United States

Location

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Columbia, South Carolina, United States

Location

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Travelers Rest, South Carolina, United States

Location

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Houston, Texas, United States

Location

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 hrs, EST), or speak with your personal physician.

Kirkland, Texas, United States

Location

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 hrs, EST), or speak with your personal physician.

San Antonio, Texas, United States

Location

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 hrs, EST), or speak with your personal physician.

Kirkland, Washington, United States

Location

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Zagreb, Croatia

Location

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 hrs, EST), or speak with your personal physician.

Moscow, Russia

Location

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 hrs, EST), or speak with your personal physician.

Saint Petersburg, Russia

Location

Related Publications (7)

  • Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.

    PMID: 24423017DERIVED

  • Detke HC, Zhao F, Witte MM. Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data. BMC Psychiatry. 2012 May 30;12:51. doi: 10.1186/1471-244X-12-51.

    PMID: 22646847DERIVED

  • Witte MM, Case MG, Schuh KJ, Ascher-Svanum H. Effects of olanzapine long-acting injection on levels of functioning among acutely ill patients with schizophrenia. Curr Med Res Opin. 2012 Mar;28(3):315-23. doi: 10.1185/03007995.2012.657300. Epub 2012 Jan 31.

    PMID: 22236137DERIVED

  • Ascher-Svanum H, Zhao F, Detke HC, Nyhuis AW, Lawson AH, Stauffer VL, Montgomery W, Witte MM, McDonnell DP. Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia. BMC Psychiatry. 2011 Sep 23;11:152. doi: 10.1186/1471-244X-11-152.

    PMID: 21943257DERIVED

  • McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.

    PMID: 20537130DERIVED

  • Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.

    PMID: 20537128DERIVED

  • Lauriello J, Lambert T, Andersen S, Lin D, Taylor CC, McDonnell D. An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia. J Clin Psychiatry. 2008 May;69(5):790-9. doi: 10.4088/jcp.v69n0512.

    PMID: 18452346DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

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

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2004

First Posted

July 28, 2004

Study Start

June 1, 2004

Study Completion

April 1, 2005

Last Updated

June 12, 2007

Record last verified: 2007-06

Locations

US(34)RU(2)CR(1)