Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00759421
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Sertindole; Drug: Olanzapine	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Sertindole; 12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Active Comparator: 2	Drug: Olanzapine; 10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days; Other Names: Zyprexa

Outcome Measures

Primary Outcome Measures

1. Global cognitive composite score [12 weeks]

Secondary Outcome Measures

1. 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 [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with schizophrenia

• Participation in 11286 study

• Capable of completing all study-related psychometric activities for the duration of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TWN001	Tapei		Taiwan	112

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT00759421
• Other Study ID Numbers: 11286B
• First Posted: Sep 25, 2008
• Last Update Posted: Sep 16, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by H. Lundbeck A/S: Schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Olanzapine; Sertindole

Study Results

No Results Posted as of Sep 16, 2013