CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 931 enrolled
Drug / intervention
Intramuscular olanzapine depotdrug
Likely dose
Intramuscular olanzapine depot 45-405 mg on a 2-, 3-, or 4-week intervalAI-extracted
Key inclusion· 3
  • ✓Confirmed diagnosis of schizophrenia or schizoaffective disorder
  • ✓Completion of prior IM olanzapine depot study within 10 days (if permitted by that study)
  • ✓Female patients of childbearing potential must use medically accepted contraception
Key exclusion· 4
  • ✕Participation in another investigational drug trial (including olanzapine) within 30 days prior to entry
  • ✕Pregnancy or breastfeeding
  • ✕Acute, serious, or unstable medical conditions (other than schizophrenia or schizoaffective disorder)
  • ✕Substance dependence (except nicotine or caffeine) within 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00088465
NCT00088465Phase 3Completed
CompareCT.gov

An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

Eli Lilly and Company·interventional·Posted Jul 27, 2004·Updated Jan 11, 2012

In Brief

A Phase 3 clinical trial evaluating Intramuscular olanzapine depot for Schizophrenic Disorders and Schizoaffective Disorder. Completed, enrolled 931 participants across 92 sites in 25 countries.

Detailed Summary

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: * Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, * Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, * Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenic Disorders, Schizoaffective Disorder
CountriesArgentina, Australia, Austria, Belgium, Brazil, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2004
Enrollment StartAug 1, 2004
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 21.9 years ago

Interventions

Intramuscular olanzapine depotdrug

45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.