Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
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|ClinicalTrials.gov Identifier: NCT00145496|
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : March 25, 2010
Last Update Posted : September 25, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Asenapine Drug: Olanzapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||468 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia.|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
5-10 mg sublingually twice daily for up to 26 weeks
|Active Comparator: olanzapine||
5-20 mg by mouth once daily for up to 26 weeks
Primary Outcome Measures :
- Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score [ Time Frame: Day 182 ]The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.
Secondary Outcome Measures :
- Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score [ Time Frame: Day 182 ]The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.
- Change From Baseline in Body Weight [ Time Frame: Day 182 ]
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