Text Size

Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00759421
First received: September 24, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 24, 2008
September 24, 2008
October 2006
March 2008   (final data collection date for primary outcome measure)
Global cognitive composite score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ]
Same as current
 
 
 
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

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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
    Other Name: Zyprexa
  • Experimental: 1
    Intervention: Drug: Sertindole
  • Active Comparator: 2
    Intervention: Drug: Olanzapine
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
April 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with schizophrenia
  • Participation in 11286 study
  • Capable of completing all study-related psychometric activities for the duration of the study
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00759421
11286B
No
H. Lundbeck A/S
H. Lundbeck A/S
 
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP