6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543(25544)(COMPLETED)(P05777)
This study has been completed.
Information provided by (Responsible Party):
First received: December 12, 2005
Last updated: October 25, 2013
Last verified: October 2013
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ] [ Designated as safety issue: No ]Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].
Secondary Outcome Measures:
- Change in Quality of Life Measured by Quality of Life Scale (QLS) [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ] [ Designated as safety issue: No ]Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].
|Study Start Date:||December 2005|
|Study Completion Date:||January 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
5-10 mg sublingually twice daily for 26 weeks
Active Comparator: 2
5-20 mg by mouth once daily for 26 weeks
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