Exploratory Cognition Study of Sertindole in Patients With Schizophrenia
The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on neurocognitive functioning in patients with schizophrenia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||An Exploratory Cognition Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Neurocognitive Effects of 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia|
- Global cognitive composite score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Cognitive performance in the following domains: 1) Working memory; 2) Attention and vigilance; 3) Verbal learning and memory; 4) Visual learning and memory; 5) Reasoning and problem solving; 6) Speed of processing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
|Active Comparator: 2||
10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Other Name: Zyprexa
Cognitive deficits, including impairments in areas such as memory, attention, and executive function, are major determinants and predictors of long-term disability in schizophrenia. At present, available antipsychotic medications are relatively ineffective in improving cognition. However, scientific discoveries during the past decade suggest that it may be possible to develop medications that are effective in improving cognition in schizophrenia.
One of the important reasons to focus on cognitive deficits as a target for pharmacological treatment, is the association found between cognitive impairment and social dysfunction observed in patients with schizophrenia. Pervasive cognitive deficits have a limiting effect on the quality of life of patients with schizophrenia including social interaction and problem solving, community living, and employment prospects.