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Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

NCT ID: NCT00759421

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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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

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Schizophrenia

Keywords

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Sertindole

Intervention Type DRUG

12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

2

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Interventions

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Sertindole

12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Intervention Type DRUG

Olanzapine

10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Intervention Type DRUG

Other Intervention Names

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Zyprexa

Eligibility Criteria

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Inclusion Criteria

* Patients with schizophrenia
* Participation in 11286 study
* Capable of completing all study-related psychometric activities for the duration of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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TWN001

Tapei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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11286B

Identifier Type: -

Identifier Source: org_study_id