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Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337662
First Posted: June 16, 2006
Last Update Posted: February 17, 2010
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.
Information provided by:
Eli Lilly and Company
  Purpose
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Drug: olanzapine Drug: risperidone Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups [ Time Frame: Week 2 to Week 12 ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index [ Time Frame: Week 2 to Week 12 ]
  • Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants [ Time Frame: Week 2 to Week 12 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate [ Time Frame: Week 2 and Week 12 ]
  • Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure [ Time Frame: Week 2 and Week 12 ]
  • Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure [ Time Frame: Week 2 and Week 12 ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate [ Time Frame: Week 2 and Week 12 ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure [ Time Frame: Week 2 and Week 12 ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight [ Time Frame: Week 2 and Week 12 ]

Enrollment: 628
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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


  Show 34 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00337662     History of Changes
Obsolete Identifiers: NCT00373321
Other Study ID Numbers: 10769
F1D-US-HGMN ( Other Identifier: Eli Lilly and Company )
First Submitted: June 14, 2006
First Posted: June 16, 2006
Results First Submitted: December 3, 2008
Results First Posted: August 4, 2009
Last Update Posted: February 17, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Antipsychotic Agents
Olanzapine
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