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

NCT00088465 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 931

Last updated 2012-01-11

Study results available
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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

Conditions

  • Schizophrenic Disorders
  • Schizoaffective Disorder

Interventions

DRUG

Intramuscular olanzapine depot

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

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00088465 on ClinicalTrials.gov