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Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia

NCT ID: NCT00759460

Last Updated: 2013-09-20

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

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 metabolic parameters and syndrome in patients with schizophrenia.

Detailed Description

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The prevalence of metabolic syndrome is estimated to be around 20-25% of the population and is particularly high in patients with schizophrenia. Individuals with metabolic syndrome are twice as likely to die from, and three times as likely to suffer from a heart attack or stroke compared to individuals without the syndrome.

Patients on atypical antipsychotic medication should be considered a high risk group for diabetes and cardiovascular disease. Weight gain is common in patients taking neuroleptics and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.

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 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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CN002

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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11286C

Identifier Type: -

Identifier Source: org_study_id