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Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00759421
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : September 16, 2013
Information provided by (Responsible Party):
H. Lundbeck A/S

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 Type : Interventional  (Clinical Trial)
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 : October 2006
Primary Completion Date : March 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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 Name: Zyprexa

Primary Outcome Measures :
  1. Global cognitive composite score [ Time Frame: 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 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759421

Tapei, Taiwan, 112
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00759421     History of Changes
Other Study ID Numbers: 11286B
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by H. Lundbeck A/S:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents