Phase 4
N=628
Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00337662 ↗Enrolled (actual)
628
Serious AEs
8.6%
Results posted
Aug 2009
Primary outcome: Primary: 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 — -11.90; -30.80; -14.81; -32.53 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- olanzapine (Drug); risperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-11.90; -30.80; -14.81; -32.53; -16.23; -32.90 | <0.001 sig |
| SECONDARY 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 |
-6.94; -5.85; -9.82; -9.67; -11.25; -13.06 | 0.266 |
| SECONDARY 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 |
94; 119; 95; 19 | <0.001 sig |
| SECONDARY 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 |
94; 94; 95; 85 | 0.604 |
| SECONDARY 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 |
67; 87; 122; 51 | <0.001 sig |
| SECONDARY 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 |
67; 67; 122; 112 | 0.745 |
| SECONDARY Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups |
9; 10; 175; 127 | 0.474 |
| SECONDARY Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index |
29.97; 31.05; 31.13; 0.63; 0.43; 0.10 | 0.034 sig |
| SECONDARY Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants |
5; 3; 2; 6; 1; 5 | >0.05 |
| SECONDARY Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale |
-0.06; -0.03; -0.02 | 0.355 |
| SECONDARY Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score |
-0.31; -0.13; -0.24 | 0.998 |
| SECONDARY Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score |
-0.38; 0.11; -0.16 | 0.266 |
| SECONDARY Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate |
80.49; 80.84; 77.90; -0.98; -2.52; -0.94 | 0.140 |
| SECONDARY Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure |
78.69; 78.57; 80.29; 1.01; -0.20; -1.73 | 0.254 |
| SECONDARY Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure |
93.53; 93.81; 94.60; 0.68; -0.58; -1.94 | 0.291 |
| SECONDARY Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate |
85.57; 85.32; 82.39; -1.13; -2.05; -0.56 | 0.209 |
| SECONDARY Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure |
123.20; 124.30; 123.20; 0.01; -1.35; -2.36 | 0.544 |
| SECONDARY Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight |
88.28; 90.25; 90.67; 1.85; 1.29; 0.30 | 0.026 sig |
Summary
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00337662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.