Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)
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
Lead Sponsor: Merck Sharp & Dohme Corp.
|Source||Merck Sharp & Dohme Corp.|
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.
|Start Date||September 2004|
|Completion Date||October 2006|
|Primary Completion Date||September 2006|
Intervention Type: Drug
Intervention Name: asenapine
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.
Arm Group Label: Arm 1
Intervention Type: Drug
Intervention Name: olanzapine
Description: Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.
Arm Group Label: Arm 2
Other Name: Zyprexa
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.
- Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.
- Have an uncontrolled, unstable, clinically significant medical condition.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
|Has Expanded Access||No|
|Number Of Arms||2|
Label: Arm 1
Label: Arm 2
Type: Active Comparator
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)