Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Eli Lilly and Company628 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

628

Conditions

Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Interventions

olanzapineDRUG

10-20 milligrams (mg), oral, daily, 10 weeks.

risperidoneDRUG

2-6 mg, oral, daily, for 10 weeks.

risperidoneDRUG

2-6 mg, oral, daily, 10 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

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

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).

Time frame: Weeks 0, 3, 4, 6, 8, 12

Secondary Outcomes

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

The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.

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

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Escondido, California, United States

Garden Grove, California, United States

Glendale, California, United States

National City, California, United States

Orange, California, United States

San Diego, California, United States

Santa Ana, California, United States

Washington D.C., District of Columbia, United States

Fort Lauderdale, Florida, United States

...and 24 more locations

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

'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.

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

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.

Time frame: Week 2 to Week 12

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index

Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.

Time frame: Week 2 to Week 12

Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants

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.

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

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.

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

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).

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

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.

Time frame: Week 2 to Week 12

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate

Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.