6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
asenapine
olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
asenapine
olanzapine
Outcomes
Primary Outcome Measures
Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
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)
Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00265343
Brief Title
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
asenapine
Arm Title
2
Arm Type
Active Comparator
Arm Description
olanzapine
Intervention Type
Drug
Intervention Name(s)
asenapine
Intervention Description
5-10 mg sublingually twice daily for 26 weeks
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
5-20 mg by mouth once daily for 26 weeks
Primary Outcome Measure Information:
Title
Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
Description
Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].
Time Frame
Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Secondary Outcome Measure Information:
Title
Change in Quality of Life Measured by Quality of Life Scale (QLS)
Description
Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].
Time Frame
Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22198451
Citation
Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
Results Reference
result
Learn more about this trial
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
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