Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088478
First received: July 26, 2004
Last updated: June 11, 2007
Last verified: June 2007

July 26, 2004
June 11, 2007
June 2004
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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
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Complete list of historical versions of study NCT00088478 on ClinicalTrials.gov Archive Site
  • 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
  • To evaluate the safety and tolerability of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo
  • To characterize the pharmacokinetics of olanzapine following multiple dosing with IM olanzapine depot at each of the prescribed dosing regimens
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Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

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).
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
  • Drug: Intramuscular Olanzapine Depot
  • Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
April 2005
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Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
  • One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Croatia,   Russian Federation
 
NCT00088478
5984, F1D-MC-HGJZ
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Eli Lilly and Company
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Study Director: 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
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP