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Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00337662
First received: June 14, 2006
Last updated: February 8, 2010
Last verified: February 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups [ Time Frame: Week 2 to Week 12 ] [ Designated as safety issue: No ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index [ Time Frame: Week 2 to Week 12 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants [ Time Frame: Week 2 to Week 12 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate [ Time Frame: Week 2 and Week 12 ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure [ Time Frame: Week 2 and Week 12 ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure [ Time Frame: Week 2 and Week 12 ] [ Designated as safety issue: Yes ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate [ Time Frame: Week 2 and Week 12 ] [ Designated as safety issue: Yes ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure [ Time Frame: Week 2 and Week 12 ] [ Designated as safety issue: Yes ]
  • Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight [ Time Frame: Week 2 and Week 12 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional 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
Study First Received: June 14, 2006
Results First Received: December 3, 2008
Last Updated: February 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013