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Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00337662
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : August 4, 2009
Last Update Posted : February 17, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Drug: olanzapine Drug: risperidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in Schizophrenia.
Study Start Date : May 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 1
Olanzapine for Not Early Onset response (NEO) patients
Drug: olanzapine
10-20 milligrams (mg), oral, daily, 10 weeks.
Other Names:
  • LY170053
  • Zyprexa

Active Comparator: 2
Risperidone for Not Early Onset response (NEO) patients
Drug: risperidone
2-6 mg, oral, daily, for 10 weeks.

Active Comparator: 3
Risperidone for Early Onset response (EO) patients
Drug: risperidone
2-6 mg, oral, daily, 10 weeks




Primary Outcome Measures :
  1. Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients [ Time Frame: Weeks 0, 3, 4, 6, 8, 12 ]

Secondary Outcome Measures :
  1. Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients [ Time Frame: Weeks 2, 3, 4, 6, 8, 12 ]
  2. The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Week 0 to Week 12 ]
  3. The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Week 0 to Week 12 ]
  4. Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission [ Time Frame: Week 0 to Week 12 ]
  5. Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission [ Time Frame: Week 2 to Week 12 ]
  6. Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups [ Time Frame: Week 2 to Week 12 ]
  7. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index [ Time Frame: Week 2 to Week 12 ]
  8. Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants [ Time Frame: Week 2 to Week 12 ]
  9. Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale [ Time Frame: Week 2 to Week 12 ]
  10. Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score [ Time Frame: Week 2 to Week 12 ]
  11. Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score [ Time Frame: Week 2 to Week 12 ]
  12. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate [ Time Frame: Week 2 and Week 12 ]
  13. Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure [ Time Frame: Week 2 and Week 12 ]
  14. Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure [ Time Frame: Week 2 and Week 12 ]
  15. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate [ Time Frame: Week 2 and Week 12 ]
  16. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure [ Time Frame: Week 2 and Week 12 ]
  17. Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight [ Time Frame: Week 2 and Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
  • Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
  • Patients in whom a switch to another antipsychotic medication is acutely indicated.

Exclusion Criteria:

  • Patients who are deemed nonresponsive to risperidone or olanzapine.
  • Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
  • Patients having received olanzapine or risperidone in the past 30 days.
  • Treatment with clozapine within 1 year prior to Visit 1.
  • Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
  • A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337662


Locations
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United States, Arkansas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Little Rock, Arkansas, United States, 72201
United States, California
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Escondido, California, United States, 92025
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Garden Grove, California, United States, 92845
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Glendale, California, United States, 91206
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National City, California, United States, 91950
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Orange, California, United States, 92868
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San Diego, California, United States, 92123
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Santa Ana, California, United States, 92701
United States, District of Columbia
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Washington, District of Columbia, United States, 20016
United States, Florida
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Fort Lauderdale, Florida, United States, 33319
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Hialeah, Florida, United States, 33016
United States, Illinois
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Chicago, Illinois, United States, 60640
United States, Kentucky
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
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Boston, Massachusetts, United States, 02118
United States, Mississippi
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jackson, Mississippi, United States, 39216
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kansas City, Missouri, United States, 64108
United States, Nebraska
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Omaha, Nebraska, United States, 68133
United States, New Jersey
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Clementon, New Jersey, United States, 08021
United States, New York
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Cedarhurst, New York, United States, 11516
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Olean, New York, United States, 14760
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Staten Island, New York, United States, 10312
United States, Ohio
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Toledo, Ohio, United States, 43623
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19131
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Memphis, Tennessee, United States, 38117
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin, Texas, United States, 78754
United States, Virginia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arlington, Virginia, United States, 22201
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Portsmouth, Virginia, United States, 23703
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Richmond, Virginia, United States, 23298
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kirkland, Washington, United States, 98033
Argentina
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Buenos Aires, Argentina, C1062ABF
Russian Federation
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Khotkovo, Russian Federation, 127025
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Moscow, Russian Federation, 115522
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00337662    
Obsolete Identifiers: NCT00373321
Other Study ID Numbers: 10769
F1D-US-HGMN ( Other Identifier: Eli Lilly and Company )
First Posted: June 16, 2006    Key Record Dates
Results First Posted: August 4, 2009
Last Update Posted: February 17, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators