Back to resultsEfficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
Primary Purpose
Schizophrenia, Schizoaffective Disorder
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: Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent. Exclusion Criteria: Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
Secondary Outcome Measures
Changes in PANSS subscale scores and Marder factor scores
Changes in CGI-S
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Resource utilization (as measured by frequency and length of hospital stay)
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
Population kinetics
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
Safety and tolerability: EPS (AIMS, BARS, SARS)
Adverse Events
Pregnancy Test
Blood Test
Weight and vital signs
ECGs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00212784
Brief Title
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
Official Title
A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 4, 2003 (Actual)
Primary Completion Date
March 15, 2006 (Actual)
Study Completion Date
March 15, 2006 (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
The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
asenapine
Other Intervention Name(s)
Org 5222, SCH 900274
Intervention Description
Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
Primary Outcome Measure Information:
Title
Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
Time Frame
Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
Secondary Outcome Measure Information:
Title
Changes in PANSS subscale scores and Marder factor scores
Time Frame
At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Title
Changes in CGI-S
Time Frame
At each assessment time point from baseline
Title
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Time Frame
At weeks 8, 20, 28, 36, 44 and endpoint
Title
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Time Frame
At weeks 6, 28 and endpoint
Title
Resource utilization (as measured by frequency and length of hospital stay)
Time Frame
During the study period
Title
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
Time Frame
At endpoint
Title
Population kinetics
Time Frame
Plasma samples at weeks 2 and 6 in comparison with baseline
Title
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
Time Frame
During the study period
Title
Safety and tolerability: EPS (AIMS, BARS, SARS)
Time Frame
At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Title
Adverse Events
Time Frame
continuously and up to 7 days after endpoint
Title
Pregnancy Test
Time Frame
At endpoint
Title
Blood Test
Time Frame
At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Title
Weight and vital signs
Time Frame
at all assessment time points from baseline
Title
ECGs
Time Frame
Weeks 3, 6, 24, and endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.
Exclusion Criteria:
Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20205074
Citation
Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4. Erratum In: Pharmacopsychiatry. 2011 Nov;44(7):343.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
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