Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00337662

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 Device: risperidone	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Predicting Response to Risperidone Treatment Through Identification of Early-Onset of Antipsychotic Drug Action in Schizophrenia.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Determine if early onset (EO) response to risperidone is linked to greater subsequent improvement in psychopathology as measured by comparison of PANSS total scores between risperidone-treated patients meeting EO criterion compared to those who do not. [ Time Frame: Visit 5 to 9 (9 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare mean changes in psychopathology as measured from a repeated measures analysis of PANSS total score in No Early Onset (NEO) patients who remain on risperidone (NEO-RIS) to NEO patients switched to olanzapine (NEO-OLZ). [ Time Frame: Visit 5 to 9 (9 weeks) ] [ Designated as safety issue: No ]
To compare the proportion of patients in the EO and NEO-RIS groups who show a 20% or greater reduction in PANSS total score. [ Time Frame: Visit 2 to 9 (12 weeks) ] [ Designated as safety issue: No ]
To compare the proportion of patients in the NEO-RIS and NEO-OLZ groups who show a 20% or greater reduction in PANSS total score. [ Time Frame: Visit 2 to 9 (12 weeks) ] [ Designated as safety issue: No ]
To compare the proportion of patients in the EO and NEO-RIS groups who show a 50% or greater reduction in PANSS total score from baseline or meet 'a priori' specified criteria for remission. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: No ]
To compare the proportion of patients in the NEO-RIS and NEO-OLZ groups who show a 50% or greater reduction in PANSS total score from baseline or meet 'a priori' specified criteria for remission. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: No ]
To compare the proportion of psychiatric hospitalizations for patients in the EO and NEO-RIS groups, as measured by the modified SCAP-HQ. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: No ]
To compare the safety of olanzapine and risperidone therapies among the three treatment groups using treatment emergent adverse events. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: Yes ]
To compare the safety of olanzapine and risperidone therapies among the three treatment groups using vital signs. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: Yes ]
To compare the safety of olanzapine and risperidone therapies among the three treatment groups using fasting laboratory analytes. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: Yes ]
To compare the safety of olanzapine and risperidone therapies among the three treatment groups using extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: Yes ]
To compare the safety of olanzapine and risperidone therapies among the three treatment groups using extrapyramidal symptoms as measured by the Barnes Akathisia Rating Scale. [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: Yes ]
To compare the safety of olanzapine and risperidone therapies among the three treatment groups using extrapyramidal symptoms as measured by the Abnormal Involuntary Movement Scale (AIMS). [ Time Frame: Visit 4 to 9 (10 weeks) ] [ Designated as safety issue: Yes ]

Enrollment:	524
Study Start Date:	June 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental olanzapine for NEO patients.	Drug: olanzapine 10-20mg, oral, daily, 10 weeks.
2: Active Comparator Risperidone for NEO patients	Drug: risperidone 2-6 mg, oral, daily, for 10 weeks.
3: Active Comparator Risperidone for EO patients	Device: risperidone 2-6mg, 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 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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10769, F1D-US-HGMN
Study First Received:	June 14, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00337662
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

Olanzapine
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009