Phase 3
N=468
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00145496 ↗Enrolled (actual)
468
Serious AEs
10.3%
Results posted
Mar 2010
Primary outcome: Primary: Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score — 60.4; 61.3; -9.7; -9.2 Units on a Scale — p=0.7177
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Asenapine (Drug); Olanzapine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score |
60.4; 61.3; -9.7; -9.2 | 0.7177 |
| SECONDARY Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score |
46.3; 44.2; 11.1; 7.1 | 0.0565 |
| SECONDARY Change From Baseline in Body Weight |
84.2; 84.7; 0.0; 2.6 | <0.0001 sig |
Summary
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
Eligibility Criteria
Inclusion Criteria
- Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
- No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
- Caregiver required.
Exclusion Criteria
- Have an uncontrolled, unstable clinically significant medical condition.
- Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Data sourced from ClinicalTrials.gov (NCT00145496). 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.