Back to resultsEfficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846) (ACTAMESA)
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. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent. Exclusion Criteria: Have an uncontrolled, unstable, clinically significant medical condition.
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
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)
Safety and tolerability: EPS (AIMS, BARS, SARS)
Adverse Events
Pregnancy Test
Blood Tests
Weight and vital signs
ECGs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00212771
Brief Title
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)
Acronym
ACTAMESA
Official Title
Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
October 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 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 maintaining productive employment.
Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.
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
440 (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
Other Intervention Name(s)
Zyprexa
Intervention Description
Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.
Primary Outcome Measure Information:
Title
Change in total PANSS score at endpoint
Time Frame
Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint
Secondary Outcome Measure Information:
Title
Changes in PANSS subscale scores and Marder factor scores
Time Frame
Every 24 weeks after baseline
Title
Changes in CGI-S
Time Frame
Every 12 weeks after baseline
Title
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Time Frame
Every 48 weeks after baseline
Title
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Time Frame
Every 24 weeks after baseline
Title
Resource utilization (as measured by frequency and length of hospital stay)
Time Frame
During the entire study period
Title
Safety and tolerability: EPS (AIMS, BARS, SARS)
Time Frame
Every 24 weeks after baseline
Title
Adverse Events
Time Frame
Continuously and up to 7 days after endpoint
Title
Pregnancy Test
Time Frame
At endpoint
Title
Blood Tests
Time Frame
Every 12 weeks after baseline
Title
Weight and vital signs
Time Frame
Every 4 weeks after baseline
Title
ECGs
Time Frame
Every 24 weeks after baseline
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. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.
Exclusion Criteria:
Have an uncontrolled, unstable, clinically significant medical condition.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22454251
Citation
Schoemaker J, Stet L, Vrijland P, Naber D, Panagides J, Emsley R. Long-term efficacy and safety of asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study. Pharmacopsychiatry. 2012 Jul;45(5):196-203. doi: 10.1055/s-0031-1301310. Epub 2012 Mar 27.
Results Reference
result
Learn more about this trial
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)
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