Phase 3
Completed N=306
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
Source: ClinicalTrials.gov NCT00265343 ↗Enrolled (actual)
306
Serious AEs
4.9%
Results posted
Feb 2010
Primary outcomePrimary: Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale — -16.9; -15.4 Units on a Scale
Summary
This is an extension study to further test
the efficacy and safety of asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale |
-16.9; -15.4 | — |
| SECONDARY Change in Quality of Life Measured by Quality of Life Scale (QLS) |
18.7; 16.4 | — |
Eligibility Criteria
Inclusion Criteria
- Continue to meet all demographic and procedural
inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into
this extension trial.
- Have demonstrated an acceptable
degree of compliance and completed the 25543
trial, and would benefit from continued treatment
according to the investigator.
Exclusion Criteria
- Have an uncontrolled, unstable clinically significant
medical condition.
- Have been judged to be medically
noncompliant in the management of their disease.
Data sourced from ClinicalTrials.gov (NCT00265343). 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. Informational only — not medical advice.