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Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia - Article


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Olanzapine Disintegrating Tablets

Zyprexa Zydis Injection

Clinical Trial: Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia

This study is currently recruiting patients.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company

Purpose

Key objectives of this clinical study are to:

  • Determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine
  • Evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine
  • Evaluate different doses of IM olanzapine depot to identify the best dose(s)
  • Determine the blood levels of IM olanzapine depot in patients at different points in time after an injection

Condition Treatment or Intervention Phase
Schizophrenic Disorders
  Drug: Intramuscular Olanzapine Depot
 Phase III

MedlinePlus related topics:  Schizophrenia

Study Type: Interventional
Study Design: Treatment

Official Title: A Double-Blind, Randomized Study Comparing Instramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Patients must have schizophrenia
  • Patients must be retrospectively judged by investigators, based on clinical interview and impression to have been stable on their antipsychotic medication (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study
  • Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
  • Patients must not have paticipated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.
  • Female patients must not be pregnant or breast-feeding
  • Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia

Location and Contact Information

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

Argentina
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Buenos Aires,  Argentina; Recruiting

      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Mendoza,  Argentina; Recruiting

Australia, Queensland
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., HERSTON,  Queensland,  Australia; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Nambour,  Queensland,  Australia; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Toowoomba,  Queensland,  Australia; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Southport BC,  Queensland,  Australia; Recruiting

Australia, South Australia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Glenside,  South Australia,  Australia; Recruiting

Australia, Tasmania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Hobart,  Tasmania,  Australia; Recruiting

Australia, Victoria
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Parkville,  Victoria,  Australia; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Richmond,  Victoria,  Australia; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Dandenong,  Victoria,  Australia; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Prahran,  Victoria,  Australia; Recruiting

Austria
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Wien,  Austria; Recruiting

Belgium
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Diest,  Belgium; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., LIEGE,  Belgium; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., St Denijs Westrem,  Belgium; Recruiting

Brazil
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Rio de Janeiro,  Brazil; Recruiting

      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Salvador,  Brazil; Recruiting

Brazil, Go
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Aparecida De Goian,  Go,  Brazil; Recruiting

Brazil, PR
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Curitiba,  PR,  Brazil; Recruiting

Finland
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Ekenas,  Finland; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Harjavalta,  Finland; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Helsinki,  Finland; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Pitkaniemi,  Finland; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Seinajoki,  Finland; Recruiting

France
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Paris,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Aix-en-Provence,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bayonne Cedex,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bourg-en-Bresse,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Creteil cedex,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Dijon Cedex,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Dole,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., La Roche-sur-Foron,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., La Seyne-sur-Mer,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Limoges Cedex,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Narbonne Cedex,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Nevers,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Saint-Cyr-au-Mont-d'Or,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Sanit Egreve Cedex,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Saint-Genis-Laval,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Strasbourg,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Suresnes,  France; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Toulouse,  France; Recruiting

Germany
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Hamburg,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physicianM, Muchen,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bad Saarow,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bamberg,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Berlin,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Dusseldorf,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Halle,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Kiel,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lauterbach,  Germany; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Regensburg,  Germany; Recruiting

Greece
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Chaidari,  Greece; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Larissa,  Greece; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., THESSALONIKI,  Greece; Recruiting

Hungary
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Budapest,  Hungary; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Szeged,  Hungary; Recruiting

Israel
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Bat Yam,  Israel; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Beer Yaacov,  Israel; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Hod-Hasharon,  Israel; Recruiting

Italy
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Torino,  Italy; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bari,  Italy; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Firenze,  Italy; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Porretta Terme BO,  Italy; Recruiting

Italy, CN
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Savigliano,  CN,  Italy; Recruiting

Mexico
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Mexico City,  Mexico; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Monterrey N.L.,  Mexico; Recruiting

Mexico, Guadalajara
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Zapopan,  Guadalajara,  Mexico; Recruiting

Mexico, Jalisco
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Zapopan,  Jalisco,  Mexico; Recruiting

Netherlands
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Den Haag,  Netherlands; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., ENSCHEDE,  Netherlands; Recruiting

Norway
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Hobol,  Norway; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Brattvag,  Norway; Recruiting

Poland
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Gdynia,  Poland; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Torun,  Poland; Recruiting

Portugal
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Braga,  Portugal; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Coimbra,  Portugal; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lisboa,  Portugal; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lisbon,  Portugal; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Porto,  Portugal; Recruiting

Puerto Rico
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Ponce,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Rio Piedras,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, San Juan,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Mayaguez,  Puerto Rico; Recruiting

Romania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Crajova,  Romania; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Iasi,  Romania; Recruiting

Romania, Sector 4
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bucuresti,  Sector 4,  Romania; Recruiting

Russian Federation
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Moscow,  Russian Federation; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Saint Petersburg,  Russian Federation; Recruiting

South Africa
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Randburg,  South Africa; Recruiting

South Africa, Gauteng
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Krugersdorp,  Gauteng,  South Africa; Recruiting

Spain
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Barcelona,  Spain; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Burgos,  Spain; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Malaga,  Spain; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Sevilla,  Spain; Recruiting

Sweden
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Danderyd,  Sweden; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Falkoping,  Sweden; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Huddinge,  Sweden; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Stockholm,  Sweden; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Umea,  Sweden; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Uppsala,  Sweden; Recruiting

Taiwan, Province of China
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Taipei,  Taiwan, Province of China; Recruiting

Taiwan, Province of China, Kuei-Shan
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Tao-Yaun,  Kuei-Shan,  Taiwan, Province of China; Recruiting

Taiwan, Province of China, Taiwan
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Taichung,  Taiwan,  Taiwan, Province of China; Recruiting

Turkey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Ankara,  Turkey; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Istanbul,  Turkey; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Izmir,  Turkey; Recruiting

More Information

Study ID Numbers:  5985
Record last reviewed:  April 2005
Last Updated:  April 6, 2005
Record first received:  July 26, 2004
ClinicalTrials.gov Identifier:  NCT00088491
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: June 1, 2005
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