NCT00759421

Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on neurocognitive functioning in patients with schizophrenia.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Sertindole	12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
DRUG	Olanzapine	10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-03-01
• Completion: 2008-04-01
• First posted: 2008-09-25
• Last updated: 2013-09-16

Locations

1 site across 1 country: Taiwan