6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
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 A7501013 trial to enter into this extension trial. Have demonstrated an acceptable degree of compliance and completed the A7501013 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
asenapine
olanzapine
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), 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
The QLS 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 (worst) to 126 (best), with greater values indicating better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174265
Brief Title
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
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 Protocol A7501013
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (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 of A7501013 (P05771/NCT00145496) 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
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
asenapine
Arm Type
Experimental
Arm Title
olanzapine
Arm Type
Active Comparator
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
Other Intervention Name(s)
Zyprexa
Intervention Description
5-20 mg by mouth once daily for 26 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
Description
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.
Time Frame
Baseline of A7501013 to Day 365
Secondary Outcome Measure Information:
Title
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
Description
The QLS 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 (worst) to 126 (best), with greater values indicating better quality of life.
Time Frame
Baseline of A7501013 to Day 365
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 A7501013 trial to enter into
this extension trial.
Have demonstrated an acceptable degree of compliance
and completed the A7501013 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 Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
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