Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846) (ACTAMESA)
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.
|Schizophrenia Schizoaffective Disorder||Drug: asenapine Drug: olanzapine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change in total PANSS score at endpoint [ Time Frame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint ]
- Changes in PANSS subscale scores and Marder factor scores [ Time Frame: Every 24 weeks after baseline ]
- Changes in CGI-S [ Time Frame: Every 12 weeks after baseline ]
- Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) [ Time Frame: Every 48 weeks after baseline ]
- Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) [ Time Frame: Every 24 weeks after baseline ]
- Resource utilization (as measured by frequency and length of hospital stay) [ Time Frame: During the entire study period ]
- Safety and tolerability: EPS (AIMS, BARS, SARS) [ Time Frame: Every 24 weeks after baseline ]
- Adverse Events [ Time Frame: Continuously and up to 7 days after endpoint ]
- Pregnancy Test [ Time Frame: At endpoint ]
- Blood Tests [ Time Frame: Every 12 weeks after baseline ]
- Weight and vital signs [ Time Frame: Every 4 weeks after baseline ]
- ECGs [ Time Frame: Every 24 weeks after baseline ]
|Study Start Date:||September 2004|
|Study Completion Date:||October 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
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.
|Active Comparator: Arm 2||
Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.
Other Name: Zyprexa
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