Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Interventions: Drug: olanzapine
Drug: risperidone

Registration Number: NCT00337662

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 628

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olanzapine	Olanzapine for Not Early Onset response (NEO) patients
2	risperidone	Risperidone for Not Early Onset response (NEO) patients
3	risperidone	Risperidone for Early Onset response (EO) patients

Primary Outcome Measures

Name	Time	Method
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	Weeks 0, 3, 4, 6, 8, 12	Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).

Secondary Outcome Measures

Name	Time	Method
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	Weeks 2, 3, 4, 6, 8, 12	Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 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	Week 0 to Week 12	The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.
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	Week 0 to Week 12	The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.
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	Week 0 to Week 12	'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
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	Week 2 to Week 12	'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups	Week 2 to Week 12	Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index	Week 2 to Week 12	Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants	Week 2 to Week 12	Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale	Week 2 to Week 12	Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score	Week 2 to Week 12	Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score	Week 2 to Week 12	A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate	Week 2 and Week 12	Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure	Week 2 and Week 12	Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure	Week 2 and Week 12	Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate	Week 2 and Week 12	Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure	Week 2 and Week 12	Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight	Week 2 and Week 12	Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.

Trial Locations

Locations (1): 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.
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Moscow, Russian Federation