Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034801
First received: May 2, 2002
Last updated: July 18, 2006
Last verified: July 2006

May 2, 2002
July 18, 2006
September 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00034801 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression

This is a research study comparing the safety and efficacy of two active study medications

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Depression
  • Schizophrenia
  • Schizoaffective Disorder
  • Drug: olanzapine
  • Drug: ziprasidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
378
March 2003
Not Provided

Inclusion Criteria:

  • Male or female subjects 18-60 years of age
  • Female subjects of childbearing potential must be using a medically accepted means of contraception
  • Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
  • Subjects must be considered reliable

Exclusion Criteria:

  • Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
  • Female subjects who are either pregnant or nursing
  • Uncorrected hypothyroidism or hyperthyroidism
  • Narrow-angle glaucoma
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00034801
5529, F1D-US-HGJU
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Not Provided
Eli Lilly and Company
July 2006

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